Pain
Conditions
Keywords
Analgesia, Cesarean section, Opiates
Brief summary
The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system.
Detailed description
The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system. As a double-blinded, randomized, placebo controlled study, women undergoing first, second or third cesarean section will be randomly assigned to one of 3 different groups. Group 1 will receive saline, group 2 will be given ropivacaine 0.1%, group 3 will be given ropivacaine 0.2%, all at a rate of 8ml/hr via the OnQ® pump system. Each group will also receive an 8mL bolus of the previously assigned infusate. The investigator will assess pain at rest and with movement at different time periods during the recovery process through 3 months post operatively. The investigator will also assess if the use of this system decreases the need for other pain medications and reduces the potential side-effects of pain treatment.
Interventions
Ropivacaine 0.1% is a local anaesthetic drug and will be administered as a single bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump. The bolus dose of 8ml of 0.1% ropivacaine will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr of 0.1% ropivacaine for 72 hours post-operatively.
Ropivacaine 0.2% is a local anaesthetic drug and will be administered as a single bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump. The bolus dose of 8ml of 0.2% ropivacaine will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr of 0.2% ropivacaine for 72 hours post-operatively.
Normal saline will be administered as a single bolus dose of 8ml of normal saline followed by an infusion of normal saline using the On-Q® elastomeric pump. The bolus dose of 8ml of normal saline will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr normal saline for 72 hours post-operatively.
The On-Q® elastomeric pump automatically and continuously delivers a regulated flow of 0.1% or 0.2% ropivacaine or normal saline locally to the surgical site for 72 hours post-operatively. The infusion will be delivered by pre-setting the On-Q® elastomeric pump to deliver at the rate of 8ml/hr for 72 hours post-operatively.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Female patients at Emory University Hospital Midtown undergoing non-emergent, scheduled or unscheduled first, second or third Cesarean sections 2. Patients who are American Society of Anesthesiology (ASA) Class I-III 3. Patients are at least 34 weeks pregnant 4. Patients to receive spinal anesthesia for their procedure 5. Patients who are 18 years of age or older 6. Patient willing and able to provide written informed consent
Exclusion criteria
1. Patients with 3 or more prior Cesarean sections 2. Patients undergoing emergent cesarean section with or without general anesthesia 3. Patients with known allergy to morphine, ketorolac, and/or amide local anesthetics 4. Patients who will not receive spinal anesthesia 5. Patients who are less than 34 weeks pregnant 6. Patients with significant maternal cardiac, liver or renal disease 7. Patients with maternal history of narcotic abuse or dependency 8. Patient with pre-operative fever (\>100.4 degrees F) 9. Patients less than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scores During Cough From Baseline | 2 hours post baseline, 6, 12, 24, 48, 72 hours post baseline | The intensity of pain during cough will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with no pain at the bottom and worst imaginable pain at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain. |
| Change in Pain Scores During 20°Straight Leg Raise | Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2, 6, 12, 24, 48, 72 hours post baseline | The intensity of pain during 20° straight leg raise will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with no pain at the bottom and worst imaginable pain at the top. Higher scores indicate higher intensities of pain. |
| Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline | 6 weeks, 3 months | Post-operative pain will be measured using a numerical pain scale (NPS). Subjects will be asked to indicate the level of pain with 0 being no pain and 10 being the worst imaginable pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain at the week 6 and 3 month time points through a telephone call. |
| Change in Intensity of Pain: VAPS From Baseline | 24 hours post-intervention, 48 hrs, and 72hr post-intervention. | Incisional pain will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with no pain at the bottom and worst imaginable pain at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain 2hrs post intervention, 6hr, 12hr, 24hr, 48hr, and 72hr post-intervention. |
| Change in McGill Pain Questionnaire Score From Baseline | 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months post-intervention | Pain with movement will be assessed using the self-report mini-McGill pain questionnaire, consisting of the first 15 questions of the McGill questionnaire, scores 0-3 points for each. It can theoretically range from 0 to 45, with 45 correlating with worse pain. |
| Change in Pain Scores at Rest From Baseline | 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 48 hous, 72 hours post baseline | The intensity of pain at rest will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with no pain at the bottom and worst imaginable pain at the top. Higher scores indicate higher intensities of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosing Amount of Non-steroidal Anti-inflammatory Drugs | 24 post-operatively, 72 hours post-operatively | The total dose of non-steroidal anti-inflammatory drugs (NSAIDs) in mg will be recorded for each of the first three post-operative days and after discharge as indicated, along with a cumulative total. Higher doses of NSAIDs usage indicate higher intensities of pain. |
| Change in Time From Baseline to First Dose of Rescue Medications | Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operatively | The time to dosing with the first rescue medications like, non-steroidal anti-inflammatory drugs and morphine, for breakthrough pain will be noted. A shorter time to dosing indicates an increased intensity of pain. It will be recorded in hours post intervention. |
| Amount of Opioid Use | 24 post-operatively, 72 hours post-operatively | The amount of opioid use will be quantified in terms of morphine equivalents given in mg both by post -operative day and with a cumulative total. Higher amounts of opioid use indicates higher degrees of pain. |
| Breastfeeding Success | In the post-anesthesia care unit (up to 2 hours post-operatively), 72 hours post-operatively | Breastfeeding success will be measured using LATCH scores. The LATCH system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding: L is for how well the infant latches onto the breast, A is for the amount of audible swallowing noted, T is for the mother's nipple type, C is for the mother's level of comfort and H is for the amount of help the mother needs to hold her infant to the breast. The theoretical range of the Latch score is 0 to 10. Higher scores indicate higher success with breastfeeding. |
| Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 24 hours, 48 hours, 72 hours post intervention | The cesarean section incision and the catheter insertion site will be evaluated. Any catheter or infiltrate-related issues like wound infection and seroma formation will be noted. It will be reported as number of issues. Wounds will be assessed for infection or dehiscence. Clean wound lines with no evidence of infection indicate better healing. |
| Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 weeks postintervention, 3 months postintervention | At the 6 week and 3-month follow-up phone calls the participant will be asked about the presence of wound dysesthesia (numbness, tingling, burning, pricking, allodynia, or hyperesthesia), occurrence of infection, dehiscence, and keloid formation. |
| Cost Analysis | At the time of hospital discharge (average of 3 days) | A cost analysis will occur for the inpatient stay. Costs to be assessed include cost for preparation of the drugs and devices, monitoring/supervision costs based on nursing and physician interventions and cost of days spent in the hospital. |
| Patient Satisfaction at 72 Hours Post Intervention | 72 hours post-operatively | Patient satisfaction will be assessed by using the visual analog scale (VAS). The visual analog scale (VAS) for satisfaction is a horizontal line 100mm long. At the beginning and the end, there are two descriptors representing extremes of satisfaction. The subjects will be asked to rate their satisfaction by making a vertical mark on the 100mm line, where, 0= least satisfied and 100=most satisfied. Higher scores indicate higher levels of satisfaction. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between July 2015 and July 2019.
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine 0.1% Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. | 20 |
| Ropivacaine 0.2% Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. | 19 |
| Normal Saline Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section. | 20 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Screen Failure | 2 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Ropivacaine 0.1% | Total | Normal Saline | Ropivacaine 0.2% |
|---|---|---|---|---|
| Age, Continuous | 29.3 years STANDARD_DEVIATION 4.7 | 31.2 years STANDARD_DEVIATION 5.2 | 31.9 years STANDARD_DEVIATION 5.7 | 32.1 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 56 Participants | 19 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 42 Participants | 14 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 10 Participants | 4 Participants | 5 Participants |
| Region of Enrollment United States | 20 participants | 59 participants | 20 participants | 19 participants |
| Sex: Female, Male Female | 20 Participants | 59 Participants | 20 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 0 / 20 |
Outcome results
Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline
Post-operative pain will be measured using a numerical pain scale (NPS). Subjects will be asked to indicate the level of pain with 0 being no pain and 10 being the worst imaginable pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain at the week 6 and 3 month time points through a telephone call.
Time frame: 6 weeks, 3 months
Population: The difference reflects the number of patients who were lost to follow up at 6 weeks and 3 months.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine 0.1% | Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline | Change at 6 weeks post intervention | 3 units on a scale |
| Ropivacaine 0.1% | Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline | Change at 3 months post intervention | 0 units on a scale |
| Ropivacaine 0.2% | Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline | Change at 6 weeks post intervention | 2 units on a scale |
| Ropivacaine 0.2% | Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline | Change at 3 months post intervention | 0 units on a scale |
| Normal Saline | Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline | Change at 6 weeks post intervention | 5 units on a scale |
| Normal Saline | Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline | Change at 3 months post intervention | 0 units on a scale |
Change in Intensity of Pain: VAPS From Baseline
Incisional pain will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with no pain at the bottom and worst imaginable pain at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain 2hrs post intervention, 6hr, 12hr, 24hr, 48hr, and 72hr post-intervention.
Time frame: 24 hours post-intervention, 48 hrs, and 72hr post-intervention.
Population: The differences in the number of participants reflect patients who were discharged earlier than 72 hours and patients whose assessments could not be completed because they were not available (out of the room, etc). All 0 values are real reports of no pain, which was the median score for Outcome 3. None of them represent missing values or NA.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine 0.1% | Change in Intensity of Pain: VAPS From Baseline | Change in score at 48 hours post intervention | 0 units on a scale |
| Ropivacaine 0.1% | Change in Intensity of Pain: VAPS From Baseline | Change in score at 24 hours post intervention | 0 units on a scale |
| Ropivacaine 0.1% | Change in Intensity of Pain: VAPS From Baseline | Change in score at 72 hours post intervention | 0 units on a scale |
| Ropivacaine 0.2% | Change in Intensity of Pain: VAPS From Baseline | Change in score at 48 hours post intervention | 0 units on a scale |
| Ropivacaine 0.2% | Change in Intensity of Pain: VAPS From Baseline | Change in score at 24 hours post intervention | 0 units on a scale |
| Ropivacaine 0.2% | Change in Intensity of Pain: VAPS From Baseline | Change in score at 72 hours post intervention | 0 units on a scale |
| Normal Saline | Change in Intensity of Pain: VAPS From Baseline | Change in score at 24 hours post intervention | 0 units on a scale |
| Normal Saline | Change in Intensity of Pain: VAPS From Baseline | Change in score at 72 hours post intervention | 0 units on a scale |
| Normal Saline | Change in Intensity of Pain: VAPS From Baseline | Change in score at 48 hours post intervention | 0 units on a scale |
Change in McGill Pain Questionnaire Score From Baseline
Pain with movement will be assessed using the self-report mini-McGill pain questionnaire, consisting of the first 15 questions of the McGill questionnaire, scores 0-3 points for each. It can theoretically range from 0 to 45, with 45 correlating with worse pain.
Time frame: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months post-intervention
Population: The differences in number of participants reflect patients who were discharged earlier than 72 hours and patients whose assessments could not be completed because they were not available (out of the room, etc. )
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine 0.1% | Change in McGill Pain Questionnaire Score From Baseline | 2 hrs post Baseline | 1.5 score on a scale |
| Ropivacaine 0.1% | Change in McGill Pain Questionnaire Score From Baseline | 6 hrs post Baseline | 2 score on a scale |
| Ropivacaine 0.1% | Change in McGill Pain Questionnaire Score From Baseline | 12 hrs post Baseline | 1 score on a scale |
| Ropivacaine 0.1% | Change in McGill Pain Questionnaire Score From Baseline | 24 hrs post Baseline | 1.5 score on a scale |
| Ropivacaine 0.1% | Change in McGill Pain Questionnaire Score From Baseline | 48 hrs post Baseline | 2.5 score on a scale |
| Ropivacaine 0.1% | Change in McGill Pain Questionnaire Score From Baseline | 6 weeks post Baseline | 0 score on a scale |
| Ropivacaine 0.1% | Change in McGill Pain Questionnaire Score From Baseline | 3 months post Baseline | 0 score on a scale |
| Ropivacaine 0.1% | Change in McGill Pain Questionnaire Score From Baseline | 72 hrs post Baseline | 2 score on a scale |
| Ropivacaine 0.2% | Change in McGill Pain Questionnaire Score From Baseline | 48 hrs post Baseline | 3 score on a scale |
| Ropivacaine 0.2% | Change in McGill Pain Questionnaire Score From Baseline | 2 hrs post Baseline | 2 score on a scale |
| Ropivacaine 0.2% | Change in McGill Pain Questionnaire Score From Baseline | 24 hrs post Baseline | 3 score on a scale |
| Ropivacaine 0.2% | Change in McGill Pain Questionnaire Score From Baseline | 3 months post Baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in McGill Pain Questionnaire Score From Baseline | 6 hrs post Baseline | 2 score on a scale |
| Ropivacaine 0.2% | Change in McGill Pain Questionnaire Score From Baseline | 72 hrs post Baseline | 3 score on a scale |
| Ropivacaine 0.2% | Change in McGill Pain Questionnaire Score From Baseline | 6 weeks post Baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in McGill Pain Questionnaire Score From Baseline | 12 hrs post Baseline | 1 score on a scale |
| Normal Saline | Change in McGill Pain Questionnaire Score From Baseline | 72 hrs post Baseline | 1 score on a scale |
| Normal Saline | Change in McGill Pain Questionnaire Score From Baseline | 6 weeks post Baseline | 0 score on a scale |
| Normal Saline | Change in McGill Pain Questionnaire Score From Baseline | 24 hrs post Baseline | 2 score on a scale |
| Normal Saline | Change in McGill Pain Questionnaire Score From Baseline | 3 months post Baseline | 0 score on a scale |
| Normal Saline | Change in McGill Pain Questionnaire Score From Baseline | 48 hrs post Baseline | 2 score on a scale |
| Normal Saline | Change in McGill Pain Questionnaire Score From Baseline | 12 hrs post Baseline | 2 score on a scale |
| Normal Saline | Change in McGill Pain Questionnaire Score From Baseline | 2 hrs post Baseline | 2 score on a scale |
| Normal Saline | Change in McGill Pain Questionnaire Score From Baseline | 6 hrs post Baseline | 2 score on a scale |
Change in Pain Scores at Rest From Baseline
The intensity of pain at rest will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with no pain at the bottom and worst imaginable pain at the top. Higher scores indicate higher intensities of pain.
Time frame: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 48 hous, 72 hours post baseline
Population: The differences in number of participants reflect patients who were discharged earlier than 72 hours and patients whose assessments could not be completed because they were not available (out of the room, etc. )
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine 0.1% | Change in Pain Scores at Rest From Baseline | Change in score at 6-hours post baseline | 3 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores at Rest From Baseline | Change in score at 24-hours post baseline | 8 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores at Rest From Baseline | Change in score at 48-hours post baseline | 4.5 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores at Rest From Baseline | Change in score at 12-hours post baseline | 5 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores at Rest From Baseline | Change in score at 2-hours post baseline | 5 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores at Rest From Baseline | Change in score at 72-hours post baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores at Rest From Baseline | Change in score at 12-hours post baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores at Rest From Baseline | Change in score at 72-hours post baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores at Rest From Baseline | Change in score at 6-hours post baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores at Rest From Baseline | Change in score at 2-hours post baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores at Rest From Baseline | Change in score at 24-hours post baseline | 5.5 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores at Rest From Baseline | Change in score at 48-hours post baseline | 3 score on a scale |
| Normal Saline | Change in Pain Scores at Rest From Baseline | Change in score at 72-hours post baseline | 2 score on a scale |
| Normal Saline | Change in Pain Scores at Rest From Baseline | Change in score at 2-hours post baseline | 7 score on a scale |
| Normal Saline | Change in Pain Scores at Rest From Baseline | Change in score at 6-hours post baseline | 5.5 score on a scale |
| Normal Saline | Change in Pain Scores at Rest From Baseline | Change in score at 12-hours post baseline | 1.5 score on a scale |
| Normal Saline | Change in Pain Scores at Rest From Baseline | Change in score at 24-hours post baseline | 4.5 score on a scale |
| Normal Saline | Change in Pain Scores at Rest From Baseline | Change in score at 48-hours post baseline | 2.5 score on a scale |
Change in Pain Scores During 20°Straight Leg Raise
The intensity of pain during 20° straight leg raise will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with no pain at the bottom and worst imaginable pain at the top. Higher scores indicate higher intensities of pain.
Time frame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2, 6, 12, 24, 48, 72 hours post baseline
Population: The drop of participants at 72 hours reflects patients who were discharged early, prior to the 72 hr Visit. Other missing values occurred when patients could not be located at the scheduled time because they were not in their room.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine 0.1% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 2-hours post baseline | 4 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 6-hours post baseline | 8 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 12-hours post baseline | -6.5 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 24-hours post baseline | 9 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 48-hours post baseline | 9.5 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 72-hours post baseline | 1 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 72-hours post baseline | 3 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 2-hours post baseline | 5 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 24-hours post baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 48-hours post baseline | 3 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 6-hours post baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 12-hours post baseline | 0 score on a scale |
| Normal Saline | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 6-hours post baseline | 5 score on a scale |
| Normal Saline | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 12-hours post baseline | -6.5 score on a scale |
| Normal Saline | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 24-hours post baseline | 16 score on a scale |
| Normal Saline | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 72-hours post baseline | 2.5 score on a scale |
| Normal Saline | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 2-hours post baseline | 10.5 score on a scale |
| Normal Saline | Change in Pain Scores During 20°Straight Leg Raise | Change in score at 48-hours post baseline | 17 score on a scale |
Change in Pain Scores During Cough From Baseline
The intensity of pain during cough will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with no pain at the bottom and worst imaginable pain at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain.
Time frame: 2 hours post baseline, 6, 12, 24, 48, 72 hours post baseline
Population: The drop of participants at 72 hours reflects patients who were discharged early, prior to the 72 hr Visit. Other missing values occurred when patients could not be located at the scheduled time because they were not in their room.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine 0.1% | Change in Pain Scores During Cough From Baseline | Change in score at 2-hours post baseline | 4 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During Cough From Baseline | Change in score at 6-hours post baseline | 10 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During Cough From Baseline | Change in score at 12-hours post baseline | 14.5 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During Cough From Baseline | Change in score at 24-hours post baseline | 20 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During Cough From Baseline | Change in score at 48-hours post baseline | 13 score on a scale |
| Ropivacaine 0.1% | Change in Pain Scores During Cough From Baseline | Change in score at 72-hours post baseline | 6.5 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During Cough From Baseline | Change in score at 72-hours post baseline | 0 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During Cough From Baseline | Change in score at 2-hours post baseline | 1 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During Cough From Baseline | Change in score at 24-hours post baseline | 27 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During Cough From Baseline | Change in score at 48-hours post baseline | 2 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During Cough From Baseline | Change in score at 6-hours post baseline | 3 score on a scale |
| Ropivacaine 0.2% | Change in Pain Scores During Cough From Baseline | Change in score at 12-hours post baseline | 2 score on a scale |
| Normal Saline | Change in Pain Scores During Cough From Baseline | Change in score at 6-hours post baseline | 10.5 score on a scale |
| Normal Saline | Change in Pain Scores During Cough From Baseline | Change in score at 12-hours post baseline | 15.5 score on a scale |
| Normal Saline | Change in Pain Scores During Cough From Baseline | Change in score at 72-hours post baseline | 3 score on a scale |
| Normal Saline | Change in Pain Scores During Cough From Baseline | Change in score at 24-hours post baseline | 15.5 score on a scale |
| Normal Saline | Change in Pain Scores During Cough From Baseline | Change in score at 2-hours post baseline | 20.5 score on a scale |
| Normal Saline | Change in Pain Scores During Cough From Baseline | Change in score at 48-hours post baseline | 15 score on a scale |
Amount of Opioid Use
The amount of opioid use will be quantified in terms of morphine equivalents given in mg both by post -operative day and with a cumulative total. Higher amounts of opioid use indicates higher degrees of pain.
Time frame: 24 post-operatively, 72 hours post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine 0.1% | Amount of Opioid Use | 24 hours post intervention | 0.35 mg | Standard Deviation 1.77 |
| Ropivacaine 0.1% | Amount of Opioid Use | 72 hours post intervention | 24.98 mg | Standard Deviation 37.81 |
| Ropivacaine 0.2% | Amount of Opioid Use | 24 hours post intervention | 6.45 mg | Standard Deviation 27.5 |
| Ropivacaine 0.2% | Amount of Opioid Use | 72 hours post intervention | 54.28 mg | Standard Deviation 164.3 |
| Normal Saline | Amount of Opioid Use | 24 hours post intervention | 1.65 mg | Standard Deviation 5.28 |
| Normal Saline | Amount of Opioid Use | 72 hours post intervention | 31.25 mg | Standard Deviation 41.33 |
Breastfeeding Success
Breastfeeding success will be measured using LATCH scores. The LATCH system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding: L is for how well the infant latches onto the breast, A is for the amount of audible swallowing noted, T is for the mother's nipple type, C is for the mother's level of comfort and H is for the amount of help the mother needs to hold her infant to the breast. The theoretical range of the Latch score is 0 to 10. Higher scores indicate higher success with breastfeeding.
Time frame: In the post-anesthesia care unit (up to 2 hours post-operatively), 72 hours post-operatively
Population: Data was not obtained/recorded by nurses during shift and some patients were not available (out of the room, etc).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine 0.1% | Breastfeeding Success | 2 hours post intervention | 10 score on a scale |
| Ropivacaine 0.1% | Breastfeeding Success | 72 hours post intervention | 10 score on a scale |
| Ropivacaine 0.2% | Breastfeeding Success | 2 hours post intervention | 6.5 score on a scale |
| Ropivacaine 0.2% | Breastfeeding Success | 72 hours post intervention | 10 score on a scale |
| Normal Saline | Breastfeeding Success | 2 hours post intervention | 6.5 score on a scale |
| Normal Saline | Breastfeeding Success | 72 hours post intervention | 10 score on a scale |
Change in Time From Baseline to First Dose of Rescue Medications
The time to dosing with the first rescue medications like, non-steroidal anti-inflammatory drugs and morphine, for breakthrough pain will be noted. A shorter time to dosing indicates an increased intensity of pain. It will be recorded in hours post intervention.
Time frame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ropivacaine 0.1% | Change in Time From Baseline to First Dose of Rescue Medications | 9.05 Hours |
| Ropivacaine 0.2% | Change in Time From Baseline to First Dose of Rescue Medications | 3.50 Hours |
| Normal Saline | Change in Time From Baseline to First Dose of Rescue Medications | 2 Hours |
Cost Analysis
A cost analysis will occur for the inpatient stay. Costs to be assessed include cost for preparation of the drugs and devices, monitoring/supervision costs based on nursing and physician interventions and cost of days spent in the hospital.
Time frame: At the time of hospital discharge (average of 3 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.1% | Cost Analysis | 27.9 Dollars | Standard Deviation 16.6 |
| Ropivacaine 0.2% | Cost Analysis | 26.8 Dollars | Standard Deviation 18.8 |
| Normal Saline | Cost Analysis | 31.6 Dollars | Standard Deviation 19.8 |
Dosing Amount of Non-steroidal Anti-inflammatory Drugs
The total dose of non-steroidal anti-inflammatory drugs (NSAIDs) in mg will be recorded for each of the first three post-operative days and after discharge as indicated, along with a cumulative total. Higher doses of NSAIDs usage indicate higher intensities of pain.
Time frame: 24 post-operatively, 72 hours post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine 0.1% | Dosing Amount of Non-steroidal Anti-inflammatory Drugs | 24 hours post intervention | 80 mg | Standard Deviation 246 |
| Ropivacaine 0.1% | Dosing Amount of Non-steroidal Anti-inflammatory Drugs | 72 hours post intervention | 2040 mg | Standard Deviation 799 |
| Ropivacaine 0.2% | Dosing Amount of Non-steroidal Anti-inflammatory Drugs | 24 hours post intervention | 211 mg | Standard Deviation 645 |
| Ropivacaine 0.2% | Dosing Amount of Non-steroidal Anti-inflammatory Drugs | 72 hours post intervention | 1726 mg | Standard Deviation 1075 |
| Normal Saline | Dosing Amount of Non-steroidal Anti-inflammatory Drugs | 24 hours post intervention | 379 mg | Standard Deviation 899 |
| Normal Saline | Dosing Amount of Non-steroidal Anti-inflammatory Drugs | 72 hours post intervention | 1095 mg | Standard Deviation 1228 |
Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention
The cesarean section incision and the catheter insertion site will be evaluated. Any catheter or infiltrate-related issues like wound infection and seroma formation will be noted. It will be reported as number of issues. Wounds will be assessed for infection or dehiscence. Clean wound lines with no evidence of infection indicate better healing.
Time frame: 24 hours, 48 hours, 72 hours post intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ropivacaine 0.1% | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 48 hours post intervention | 0 Participants |
| Ropivacaine 0.1% | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 24 hours post intervention | 0 Participants |
| Ropivacaine 0.1% | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 72 hours post intervention | 0 Participants |
| Ropivacaine 0.2% | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 48 hours post intervention | 0 Participants |
| Ropivacaine 0.2% | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 24 hours post intervention | 0 Participants |
| Ropivacaine 0.2% | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 72 hours post intervention | 1 Participants |
| Normal Saline | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 24 hours post intervention | 0 Participants |
| Normal Saline | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 72 hours post intervention | 0 Participants |
| Normal Saline | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | 48 hours post intervention | 0 Participants |
Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
At the 6 week and 3-month follow-up phone calls the participant will be asked about the presence of wound dysesthesia (numbness, tingling, burning, pricking, allodynia, or hyperesthesia), occurrence of infection, dehiscence, and keloid formation.
Time frame: 6 weeks postintervention, 3 months postintervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ropivacaine 0.1% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Keloid Formation | 0 Participants |
| Ropivacaine 0.1% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Wound Dysesthesia | 2 Participants |
| Ropivacaine 0.1% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months - Infection | 0 Participants |
| Ropivacaine 0.1% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months- Wound Dysesthesia | 1 Participants |
| Ropivacaine 0.1% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months- Keloid Formation | 0 Participants |
| Ropivacaine 0.1% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Dehiscence | 0 Participants |
| Ropivacaine 0.1% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Infection | 0 Participants |
| Ropivacaine 0.1% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months- Dehiscence | 0 Participants |
| Ropivacaine 0.2% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months- Wound Dysesthesia | 2 Participants |
| Ropivacaine 0.2% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Infection | 0 Participants |
| Ropivacaine 0.2% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Dehiscence | 0 Participants |
| Ropivacaine 0.2% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Keloid Formation | 0 Participants |
| Ropivacaine 0.2% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Wound Dysesthesia | 2 Participants |
| Ropivacaine 0.2% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months - Infection | 0 Participants |
| Ropivacaine 0.2% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months- Dehiscence | 0 Participants |
| Ropivacaine 0.2% | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months- Keloid Formation | 0 Participants |
| Normal Saline | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months - Infection | 0 Participants |
| Normal Saline | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Dehiscence | 0 Participants |
| Normal Saline | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months- Keloid Formation | 0 Participants |
| Normal Saline | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months- Dehiscence | 0 Participants |
| Normal Saline | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Infection | 0 Participants |
| Normal Saline | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 3 Months- Wound Dysesthesia | 3 Participants |
| Normal Saline | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Keloid Formation | 0 Participants |
| Normal Saline | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | 6 Weeks- Wound Dysesthesia | 6 Participants |
Patient Satisfaction at 72 Hours Post Intervention
Patient satisfaction will be assessed by using the visual analog scale (VAS). The visual analog scale (VAS) for satisfaction is a horizontal line 100mm long. At the beginning and the end, there are two descriptors representing extremes of satisfaction. The subjects will be asked to rate their satisfaction by making a vertical mark on the 100mm line, where, 0= least satisfied and 100=most satisfied. Higher scores indicate higher levels of satisfaction.
Time frame: 72 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.1% | Patient Satisfaction at 72 Hours Post Intervention | 60 units on a scale | Standard Deviation 40.15 |
| Ropivacaine 0.2% | Patient Satisfaction at 72 Hours Post Intervention | 61.53 units on a scale | Standard Deviation 39 |
| Normal Saline | Patient Satisfaction at 72 Hours Post Intervention | 48.3 units on a scale | Standard Deviation 35.43 |