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Use of On-Q Pump for Pain Post C-Section

Multimodal Post-Cesarean Analgesia With Spinal Morphine and Continuous Wound Infiltration of Ropivacaine Using the OnQ® Elastomeric Pump: A Dose-Ranging Study Using a High-Volume, Low-Dose Protocol

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02579629
Enrollment
64
Registered
2015-10-19
Start date
2015-07-31
Completion date
2019-07-25
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

DRUGNormal saline

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.

DEVICEOn-Q ® elastomeric pump

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

Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Change in Pain Scores During Cough From Baseline2 hours post baseline, 6, 12, 24, 48, 72 hours post baselineThe 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 RaiseBaseline (At zero time, the time of the first dosing using the On-Q catheter), 2, 6, 12, 24, 48, 72 hours post baselineThe 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 Baseline6 weeks, 3 monthsPost-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 Baseline24 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 Baseline2 hours post-intervention, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months post-interventionPain 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 Baseline2 hours post-intervention, 6 hours, 12 hours, 24 hours, 48 hous, 72 hours post baselineThe 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

MeasureTime frameDescription
Dosing Amount of Non-steroidal Anti-inflammatory Drugs24 post-operatively, 72 hours post-operativelyThe 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 MedicationsBaseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operativelyThe 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 Use24 post-operatively, 72 hours post-operativelyThe 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 SuccessIn the post-anesthesia care unit (up to 2 hours post-operatively), 72 hours post-operativelyBreastfeeding 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-intervention24 hours, 48 hours, 72 hours post interventionThe 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-intervention6 weeks postintervention, 3 months postinterventionAt 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 AnalysisAt 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 Intervention72 hours post-operativelyPatient 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

ArmCount
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
Total59

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyScreen Failure202
Overall StudyWithdrawal by Subject010

Baseline characteristics

CharacteristicRopivacaine 0.1%TotalNormal SalineRopivacaine 0.2%
Age, Continuous29.3 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 Participants3 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants56 Participants19 Participants18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants4 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
15 Participants42 Participants14 Participants13 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants1 Participants1 Participants
Race (NIH/OMB)
White
1 Participants10 Participants4 Participants5 Participants
Region of Enrollment
United States
20 participants59 participants20 participants19 participants
Sex: Female, Male
Female
20 Participants59 Participants20 Participants19 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 190 / 20
other
Total, other adverse events
0 / 200 / 190 / 20
serious
Total, serious adverse events
0 / 200 / 190 / 20

Outcome results

Primary

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.

ArmMeasureGroupValue (MEDIAN)
Ropivacaine 0.1%Change in Intensity of Pain: Numerical Pain Scale (NPS) From BaselineChange at 6 weeks post intervention3 units on a scale
Ropivacaine 0.1%Change in Intensity of Pain: Numerical Pain Scale (NPS) From BaselineChange at 3 months post intervention0 units on a scale
Ropivacaine 0.2%Change in Intensity of Pain: Numerical Pain Scale (NPS) From BaselineChange at 6 weeks post intervention2 units on a scale
Ropivacaine 0.2%Change in Intensity of Pain: Numerical Pain Scale (NPS) From BaselineChange at 3 months post intervention0 units on a scale
Normal SalineChange in Intensity of Pain: Numerical Pain Scale (NPS) From BaselineChange at 6 weeks post intervention5 units on a scale
Normal SalineChange in Intensity of Pain: Numerical Pain Scale (NPS) From BaselineChange at 3 months post intervention0 units on a scale
Primary

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.

ArmMeasureGroupValue (MEDIAN)
Ropivacaine 0.1%Change in Intensity of Pain: VAPS From BaselineChange in score at 48 hours post intervention0 units on a scale
Ropivacaine 0.1%Change in Intensity of Pain: VAPS From BaselineChange in score at 24 hours post intervention0 units on a scale
Ropivacaine 0.1%Change in Intensity of Pain: VAPS From BaselineChange in score at 72 hours post intervention0 units on a scale
Ropivacaine 0.2%Change in Intensity of Pain: VAPS From BaselineChange in score at 48 hours post intervention0 units on a scale
Ropivacaine 0.2%Change in Intensity of Pain: VAPS From BaselineChange in score at 24 hours post intervention0 units on a scale
Ropivacaine 0.2%Change in Intensity of Pain: VAPS From BaselineChange in score at 72 hours post intervention0 units on a scale
Normal SalineChange in Intensity of Pain: VAPS From BaselineChange in score at 24 hours post intervention0 units on a scale
Normal SalineChange in Intensity of Pain: VAPS From BaselineChange in score at 72 hours post intervention0 units on a scale
Normal SalineChange in Intensity of Pain: VAPS From BaselineChange in score at 48 hours post intervention0 units on a scale
Primary

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. )

ArmMeasureGroupValue (MEDIAN)
Ropivacaine 0.1%Change in McGill Pain Questionnaire Score From Baseline2 hrs post Baseline1.5 score on a scale
Ropivacaine 0.1%Change in McGill Pain Questionnaire Score From Baseline6 hrs post Baseline2 score on a scale
Ropivacaine 0.1%Change in McGill Pain Questionnaire Score From Baseline12 hrs post Baseline1 score on a scale
Ropivacaine 0.1%Change in McGill Pain Questionnaire Score From Baseline24 hrs post Baseline1.5 score on a scale
Ropivacaine 0.1%Change in McGill Pain Questionnaire Score From Baseline48 hrs post Baseline2.5 score on a scale
Ropivacaine 0.1%Change in McGill Pain Questionnaire Score From Baseline6 weeks post Baseline0 score on a scale
Ropivacaine 0.1%Change in McGill Pain Questionnaire Score From Baseline3 months post Baseline0 score on a scale
Ropivacaine 0.1%Change in McGill Pain Questionnaire Score From Baseline72 hrs post Baseline2 score on a scale
Ropivacaine 0.2%Change in McGill Pain Questionnaire Score From Baseline48 hrs post Baseline3 score on a scale
Ropivacaine 0.2%Change in McGill Pain Questionnaire Score From Baseline2 hrs post Baseline2 score on a scale
Ropivacaine 0.2%Change in McGill Pain Questionnaire Score From Baseline24 hrs post Baseline3 score on a scale
Ropivacaine 0.2%Change in McGill Pain Questionnaire Score From Baseline3 months post Baseline0 score on a scale
Ropivacaine 0.2%Change in McGill Pain Questionnaire Score From Baseline6 hrs post Baseline2 score on a scale
Ropivacaine 0.2%Change in McGill Pain Questionnaire Score From Baseline72 hrs post Baseline3 score on a scale
Ropivacaine 0.2%Change in McGill Pain Questionnaire Score From Baseline6 weeks post Baseline0 score on a scale
Ropivacaine 0.2%Change in McGill Pain Questionnaire Score From Baseline12 hrs post Baseline1 score on a scale
Normal SalineChange in McGill Pain Questionnaire Score From Baseline72 hrs post Baseline1 score on a scale
Normal SalineChange in McGill Pain Questionnaire Score From Baseline6 weeks post Baseline0 score on a scale
Normal SalineChange in McGill Pain Questionnaire Score From Baseline24 hrs post Baseline2 score on a scale
Normal SalineChange in McGill Pain Questionnaire Score From Baseline3 months post Baseline0 score on a scale
Normal SalineChange in McGill Pain Questionnaire Score From Baseline48 hrs post Baseline2 score on a scale
Normal SalineChange in McGill Pain Questionnaire Score From Baseline12 hrs post Baseline2 score on a scale
Normal SalineChange in McGill Pain Questionnaire Score From Baseline2 hrs post Baseline2 score on a scale
Normal SalineChange in McGill Pain Questionnaire Score From Baseline6 hrs post Baseline2 score on a scale
Primary

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. )

ArmMeasureGroupValue (MEDIAN)
Ropivacaine 0.1%Change in Pain Scores at Rest From BaselineChange in score at 6-hours post baseline3 score on a scale
Ropivacaine 0.1%Change in Pain Scores at Rest From BaselineChange in score at 24-hours post baseline8 score on a scale
Ropivacaine 0.1%Change in Pain Scores at Rest From BaselineChange in score at 48-hours post baseline4.5 score on a scale
Ropivacaine 0.1%Change in Pain Scores at Rest From BaselineChange in score at 12-hours post baseline5 score on a scale
Ropivacaine 0.1%Change in Pain Scores at Rest From BaselineChange in score at 2-hours post baseline5 score on a scale
Ropivacaine 0.1%Change in Pain Scores at Rest From BaselineChange in score at 72-hours post baseline0 score on a scale
Ropivacaine 0.2%Change in Pain Scores at Rest From BaselineChange in score at 12-hours post baseline0 score on a scale
Ropivacaine 0.2%Change in Pain Scores at Rest From BaselineChange in score at 72-hours post baseline0 score on a scale
Ropivacaine 0.2%Change in Pain Scores at Rest From BaselineChange in score at 6-hours post baseline0 score on a scale
Ropivacaine 0.2%Change in Pain Scores at Rest From BaselineChange in score at 2-hours post baseline0 score on a scale
Ropivacaine 0.2%Change in Pain Scores at Rest From BaselineChange in score at 24-hours post baseline5.5 score on a scale
Ropivacaine 0.2%Change in Pain Scores at Rest From BaselineChange in score at 48-hours post baseline3 score on a scale
Normal SalineChange in Pain Scores at Rest From BaselineChange in score at 72-hours post baseline2 score on a scale
Normal SalineChange in Pain Scores at Rest From BaselineChange in score at 2-hours post baseline7 score on a scale
Normal SalineChange in Pain Scores at Rest From BaselineChange in score at 6-hours post baseline5.5 score on a scale
Normal SalineChange in Pain Scores at Rest From BaselineChange in score at 12-hours post baseline1.5 score on a scale
Normal SalineChange in Pain Scores at Rest From BaselineChange in score at 24-hours post baseline4.5 score on a scale
Normal SalineChange in Pain Scores at Rest From BaselineChange in score at 48-hours post baseline2.5 score on a scale
Primary

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.

ArmMeasureGroupValue (MEDIAN)
Ropivacaine 0.1%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 2-hours post baseline4 score on a scale
Ropivacaine 0.1%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 6-hours post baseline8 score on a scale
Ropivacaine 0.1%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 12-hours post baseline-6.5 score on a scale
Ropivacaine 0.1%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 24-hours post baseline9 score on a scale
Ropivacaine 0.1%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 48-hours post baseline9.5 score on a scale
Ropivacaine 0.1%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 72-hours post baseline1 score on a scale
Ropivacaine 0.2%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 72-hours post baseline3 score on a scale
Ropivacaine 0.2%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 2-hours post baseline5 score on a scale
Ropivacaine 0.2%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 24-hours post baseline0 score on a scale
Ropivacaine 0.2%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 48-hours post baseline3 score on a scale
Ropivacaine 0.2%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 6-hours post baseline0 score on a scale
Ropivacaine 0.2%Change in Pain Scores During 20°Straight Leg RaiseChange in score at 12-hours post baseline0 score on a scale
Normal SalineChange in Pain Scores During 20°Straight Leg RaiseChange in score at 6-hours post baseline5 score on a scale
Normal SalineChange in Pain Scores During 20°Straight Leg RaiseChange in score at 12-hours post baseline-6.5 score on a scale
Normal SalineChange in Pain Scores During 20°Straight Leg RaiseChange in score at 24-hours post baseline16 score on a scale
Normal SalineChange in Pain Scores During 20°Straight Leg RaiseChange in score at 72-hours post baseline2.5 score on a scale
Normal SalineChange in Pain Scores During 20°Straight Leg RaiseChange in score at 2-hours post baseline10.5 score on a scale
Normal SalineChange in Pain Scores During 20°Straight Leg RaiseChange in score at 48-hours post baseline17 score on a scale
Primary

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.

ArmMeasureGroupValue (MEDIAN)
Ropivacaine 0.1%Change in Pain Scores During Cough From BaselineChange in score at 2-hours post baseline4 score on a scale
Ropivacaine 0.1%Change in Pain Scores During Cough From BaselineChange in score at 6-hours post baseline10 score on a scale
Ropivacaine 0.1%Change in Pain Scores During Cough From BaselineChange in score at 12-hours post baseline14.5 score on a scale
Ropivacaine 0.1%Change in Pain Scores During Cough From BaselineChange in score at 24-hours post baseline20 score on a scale
Ropivacaine 0.1%Change in Pain Scores During Cough From BaselineChange in score at 48-hours post baseline13 score on a scale
Ropivacaine 0.1%Change in Pain Scores During Cough From BaselineChange in score at 72-hours post baseline6.5 score on a scale
Ropivacaine 0.2%Change in Pain Scores During Cough From BaselineChange in score at 72-hours post baseline0 score on a scale
Ropivacaine 0.2%Change in Pain Scores During Cough From BaselineChange in score at 2-hours post baseline1 score on a scale
Ropivacaine 0.2%Change in Pain Scores During Cough From BaselineChange in score at 24-hours post baseline27 score on a scale
Ropivacaine 0.2%Change in Pain Scores During Cough From BaselineChange in score at 48-hours post baseline2 score on a scale
Ropivacaine 0.2%Change in Pain Scores During Cough From BaselineChange in score at 6-hours post baseline3 score on a scale
Ropivacaine 0.2%Change in Pain Scores During Cough From BaselineChange in score at 12-hours post baseline2 score on a scale
Normal SalineChange in Pain Scores During Cough From BaselineChange in score at 6-hours post baseline10.5 score on a scale
Normal SalineChange in Pain Scores During Cough From BaselineChange in score at 12-hours post baseline15.5 score on a scale
Normal SalineChange in Pain Scores During Cough From BaselineChange in score at 72-hours post baseline3 score on a scale
Normal SalineChange in Pain Scores During Cough From BaselineChange in score at 24-hours post baseline15.5 score on a scale
Normal SalineChange in Pain Scores During Cough From BaselineChange in score at 2-hours post baseline20.5 score on a scale
Normal SalineChange in Pain Scores During Cough From BaselineChange in score at 48-hours post baseline15 score on a scale
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Ropivacaine 0.1%Amount of Opioid Use24 hours post intervention0.35 mgStandard Deviation 1.77
Ropivacaine 0.1%Amount of Opioid Use72 hours post intervention24.98 mgStandard Deviation 37.81
Ropivacaine 0.2%Amount of Opioid Use24 hours post intervention6.45 mgStandard Deviation 27.5
Ropivacaine 0.2%Amount of Opioid Use72 hours post intervention54.28 mgStandard Deviation 164.3
Normal SalineAmount of Opioid Use24 hours post intervention1.65 mgStandard Deviation 5.28
Normal SalineAmount of Opioid Use72 hours post intervention31.25 mgStandard Deviation 41.33
Secondary

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).

ArmMeasureGroupValue (MEDIAN)
Ropivacaine 0.1%Breastfeeding Success2 hours post intervention10 score on a scale
Ropivacaine 0.1%Breastfeeding Success72 hours post intervention10 score on a scale
Ropivacaine 0.2%Breastfeeding Success2 hours post intervention6.5 score on a scale
Ropivacaine 0.2%Breastfeeding Success72 hours post intervention10 score on a scale
Normal SalineBreastfeeding Success2 hours post intervention6.5 score on a scale
Normal SalineBreastfeeding Success72 hours post intervention10 score on a scale
Secondary

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

ArmMeasureValue (MEDIAN)
Ropivacaine 0.1%Change in Time From Baseline to First Dose of Rescue Medications9.05 Hours
Ropivacaine 0.2%Change in Time From Baseline to First Dose of Rescue Medications3.50 Hours
Normal SalineChange in Time From Baseline to First Dose of Rescue Medications2 Hours
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Ropivacaine 0.1%Cost Analysis27.9 DollarsStandard Deviation 16.6
Ropivacaine 0.2%Cost Analysis26.8 DollarsStandard Deviation 18.8
Normal SalineCost Analysis31.6 DollarsStandard Deviation 19.8
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Ropivacaine 0.1%Dosing Amount of Non-steroidal Anti-inflammatory Drugs24 hours post intervention80 mgStandard Deviation 246
Ropivacaine 0.1%Dosing Amount of Non-steroidal Anti-inflammatory Drugs72 hours post intervention2040 mgStandard Deviation 799
Ropivacaine 0.2%Dosing Amount of Non-steroidal Anti-inflammatory Drugs24 hours post intervention211 mgStandard Deviation 645
Ropivacaine 0.2%Dosing Amount of Non-steroidal Anti-inflammatory Drugs72 hours post intervention1726 mgStandard Deviation 1075
Normal SalineDosing Amount of Non-steroidal Anti-inflammatory Drugs24 hours post intervention379 mgStandard Deviation 899
Normal SalineDosing Amount of Non-steroidal Anti-inflammatory Drugs72 hours post intervention1095 mgStandard Deviation 1228
Secondary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ropivacaine 0.1%Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention48 hours post intervention0 Participants
Ropivacaine 0.1%Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention24 hours post intervention0 Participants
Ropivacaine 0.1%Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention72 hours post intervention0 Participants
Ropivacaine 0.2%Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention48 hours post intervention0 Participants
Ropivacaine 0.2%Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention24 hours post intervention0 Participants
Ropivacaine 0.2%Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention72 hours post intervention1 Participants
Normal SalineNumber of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention24 hours post intervention0 Participants
Normal SalineNumber of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention72 hours post intervention0 Participants
Normal SalineNumber of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention48 hours post intervention0 Participants
Secondary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ropivacaine 0.1%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Keloid Formation0 Participants
Ropivacaine 0.1%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Wound Dysesthesia2 Participants
Ropivacaine 0.1%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months - Infection0 Participants
Ropivacaine 0.1%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months- Wound Dysesthesia1 Participants
Ropivacaine 0.1%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months- Keloid Formation0 Participants
Ropivacaine 0.1%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Dehiscence0 Participants
Ropivacaine 0.1%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Infection0 Participants
Ropivacaine 0.1%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months- Dehiscence0 Participants
Ropivacaine 0.2%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months- Wound Dysesthesia2 Participants
Ropivacaine 0.2%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Infection0 Participants
Ropivacaine 0.2%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Dehiscence0 Participants
Ropivacaine 0.2%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Keloid Formation0 Participants
Ropivacaine 0.2%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Wound Dysesthesia2 Participants
Ropivacaine 0.2%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months - Infection0 Participants
Ropivacaine 0.2%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months- Dehiscence0 Participants
Ropivacaine 0.2%Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months- Keloid Formation0 Participants
Normal SalineNumber of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months - Infection0 Participants
Normal SalineNumber of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Dehiscence0 Participants
Normal SalineNumber of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months- Keloid Formation0 Participants
Normal SalineNumber of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months- Dehiscence0 Participants
Normal SalineNumber of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Infection0 Participants
Normal SalineNumber of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention3 Months- Wound Dysesthesia3 Participants
Normal SalineNumber of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Keloid Formation0 Participants
Normal SalineNumber of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention6 Weeks- Wound Dysesthesia6 Participants
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Ropivacaine 0.1%Patient Satisfaction at 72 Hours Post Intervention60 units on a scaleStandard Deviation 40.15
Ropivacaine 0.2%Patient Satisfaction at 72 Hours Post Intervention61.53 units on a scaleStandard Deviation 39
Normal SalinePatient Satisfaction at 72 Hours Post Intervention48.3 units on a scaleStandard Deviation 35.43

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026