Pain, Postoperative
Conditions
Keywords
post c section pain, pain control after baby, nerve block for post delivery pain
Brief summary
the purpose of this study is to compare opioid consumption in morphine equivalents between the groups that received postoperative analgesia with intrathecal morphine versus US guided QL blocks versus US guided QL catheters
Interventions
DRUGIntrathecal morphine sulfate (ITM)
Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
DRUGBupivacaine hydrochloride
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Elective C section via Pfannenstiel incision * Living singleton pregnancy * Gestation week at least 37 weeks * American Society of Anesthesiologists (ASA) status 1, 2 and 3 * Primary and secondary C sections
Exclusion criteria
* Chronic pain * Opioid tolerant patients * Allergy to drugs used in the study. * Cognitive dysfunction * BMI \> 40 * Coagulation disorder * Local infection * Inability to tolerate oral medication * Previous intra-abdominal surgery * Patients who will receive a combined spinal epidural for their C section * Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.- local wound infiltration by surgeon) * Patients who received sedation or general anesthesia during their C section (midazolam, ketamine, fentanyl, propofol, hydromorphone)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | upto 72 hours post surgery | Total narcotic consumption in morphine equivalents (in milligrams) for the first 72 hours after surgery was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Static Pain as Measured by the Numerical Pain Score (NPS) | 6, 12, 24, 48 and 72 hours post surgery | To assess static pain scores, NPS will be recorded while the participant is supine in bed. NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10). |
| Severity of Pruritus as Assessed by a Scale | 24, 48 and 72 hours post surgery | This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10. |
| Severity of Nausea as Assessed by a Scale | 24, 48 and 72 hours post surgery | This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10. |
| Severity of Vomiting as Assessed by a Scale | 24, 48 and 72 hours post surgery | This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10. |
| Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 12,24,48 hours post surgery | Total narcotic consumption in morphine equivalents (in milligrams) for 12, 24 and 48 hours after surgery was calculated. |
| Patient Satisfaction as Assessed by Likert Scale | 24 hours post surgery | Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1). |
| Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 6, 12, 24, 48 and 72 hours post surgery | To assess dynamic pain scores, the participant be asked to sit up in bed from supine to sitting, and the NPS will then be recorded. If the participant is ambulating, the dynamic pain score during ambulation (rather during sitting) will be assessed. NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10). |
| Time to First Analgesic Request | 72 hours post surgery | — |
| Severity of Sedation as Assessed by a Scale | 24, 48 and 72 hours post surgery | This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Control Group) Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion | 1 |
| Group 2(Bupivacaine Hydrochloride Group) Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion | 1 |
| Group 3 (Ropivacaine Hydrochloride Group) ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Group 2(Bupivacaine Hydrochloride Group) | Group 3 (Ropivacaine Hydrochloride Group) | Total | Group 1 (Control Group) |
|---|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 0 | 36 years STANDARD_DEVIATION 0 | 31.66 years STANDARD_DEVIATION 5.13 | 26 years STANDARD_DEVIATION 0 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 1 participants | 1 participants | 3 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 3 Participants | 1 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 / 1 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 1 / 1 | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
Total narcotic consumption in morphine equivalents (in milligrams) for the first 72 hours after surgery was calculated.
Time frame: upto 72 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control Group) | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 25 milligrams | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 12.5 milligrams | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 0 milligrams | Standard Deviation 0 |
Secondary
Dynamic Pain as Measured by the Numerical Pain Score (NPS)
To assess dynamic pain scores, the participant be asked to sit up in bed from supine to sitting, and the NPS will then be recorded. If the participant is ambulating, the dynamic pain score during ambulation (rather during sitting) will be assessed. NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10).
Time frame: 6, 12, 24, 48 and 72 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 48 hours | 4 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 24 hours | 8 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 72 hours | 7 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 12 hours | 6 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 6 hours | 0 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 6 hours | 3 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 12 hours | 6 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 24 hours | 6 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 48 hours | 2 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 72 hours | 1 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 72 hours | 1 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 48 hours | 2 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 6 hours | 1 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 24 hours | 2 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Dynamic Pain as Measured by the Numerical Pain Score (NPS) | 12 hours | 1 score on a scale | Standard Deviation 0 |
Secondary
Patient Satisfaction as Assessed by Likert Scale
Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1).
Time frame: 72 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | quality of sleep | 3 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | ability to ambulate | 2 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | ability to breast or formula feed | 3 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | ability to feed and take care of newborn | 3 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to feed and take care of newborn | 4 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | quality of sleep | 5 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to breast or formula feed | 4 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to ambulate | 4 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to feed and take care of newborn | 5 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to ambulate | 5 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to breast or formula feed | 5 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | quality of sleep | 5 score on a scale | Standard Deviation 0 |
Secondary
Patient Satisfaction as Assessed by Likert Scale
Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1).
Time frame: 48 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | quality of sleep | 4 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | ability to ambulate | 4 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | ability to breast or formula feed | 4 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | ability to feed and take care of newborn at 24 hours | 4 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to feed and take care of newborn at 24 hours | 4 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | quality of sleep | 4 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to breast or formula feed | 3 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to ambulate | 4 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to feed and take care of newborn at 24 hours | 4 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to ambulate | 5 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to breast or formula feed | 5 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | quality of sleep | 5 score on a scale | Standard Deviation 0 |
Secondary
Patient Satisfaction as Assessed by Likert Scale
Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1).
Time frame: 24 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | quality of sleep | 4 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | ability to ambulate | 2 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | ability to breast or formula feed | 4 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Patient Satisfaction as Assessed by Likert Scale | ability to feed and take care of newborn at 24 hours | 3 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to feed and take care of newborn at 24 hours | 3 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | quality of sleep | 3 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to breast or formula feed | 3 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to ambulate | 3 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to feed and take care of newborn at 24 hours | 5 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to ambulate | 5 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | ability to breast or formula feed | 5 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Patient Satisfaction as Assessed by Likert Scale | quality of sleep | 4 score on a scale | Standard Deviation 0 |
Secondary
Severity of Nausea as Assessed by a Scale
This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.
Time frame: 24, 48 and 72 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Severity of Nausea as Assessed by a Scale | 48 houts | 0 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Severity of Nausea as Assessed by a Scale | 24 hours | 0 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Severity of Nausea as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Nausea as Assessed by a Scale | 48 houts | 0 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Nausea as Assessed by a Scale | 24 hours | 2 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Nausea as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Nausea as Assessed by a Scale | 24 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Nausea as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Nausea as Assessed by a Scale | 48 houts | 0 score on a scale | Standard Deviation 0 |
Secondary
Severity of Pruritus as Assessed by a Scale
This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.
Time frame: 24, 48 and 72 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Severity of Pruritus as Assessed by a Scale | 48 hours | 0 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Severity of Pruritus as Assessed by a Scale | 24 hours | 6 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Severity of Pruritus as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Pruritus as Assessed by a Scale | 48 hours | 1 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Pruritus as Assessed by a Scale | 24 hours | 2 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Pruritus as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Pruritus as Assessed by a Scale | 24 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Pruritus as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Pruritus as Assessed by a Scale | 48 hours | 0 score on a scale | Standard Deviation 0 |
Secondary
Severity of Sedation as Assessed by a Scale
This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.
Time frame: 24, 48 and 72 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Severity of Sedation as Assessed by a Scale | 48 hours | 0 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Severity of Sedation as Assessed by a Scale | 24 hours | 0 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Severity of Sedation as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Sedation as Assessed by a Scale | 48 hours | 1 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Sedation as Assessed by a Scale | 24 hours | 3 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Sedation as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Sedation as Assessed by a Scale | 24 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Sedation as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Sedation as Assessed by a Scale | 48 hours | 1 score on a scale | Standard Deviation 0 |
Secondary
Severity of Vomiting as Assessed by a Scale
This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.
Time frame: 24, 48 and 72 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Severity of Vomiting as Assessed by a Scale | 48 hours | 0 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Severity of Vomiting as Assessed by a Scale | 24 hours | 0 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Severity of Vomiting as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Vomiting as Assessed by a Scale | 48 hours | 0 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Vomiting as Assessed by a Scale | 24 hours | 3 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Severity of Vomiting as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Vomiting as Assessed by a Scale | 24 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Vomiting as Assessed by a Scale | 72 hours | 0 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Severity of Vomiting as Assessed by a Scale | 48 hours | 0 score on a scale | Standard Deviation 0 |
Secondary
Static Pain as Measured by the Numerical Pain Score (NPS)
To assess static pain scores, NPS will be recorded while the participant is supine in bed. NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10).
Time frame: 6, 12, 24, 48 and 72 hours post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 48 hours | 2 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 24 hours | 3.5 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 6 hours | 0 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 12 hours | 0 score on a scale | Standard Deviation 0 |
| Group 1 (Control Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 72 hours | 4 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 24 hours | 4 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 6 hours | 2 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 12 hours | 4 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 48 hours | 2 score on a scale | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 72 hours | 1 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 72 hours | 1 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 48 hours | 2 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 6 hours | 1 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 24 hours | 2 score on a scale | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Static Pain as Measured by the Numerical Pain Score (NPS) | 12 hours | 0 score on a scale | Standard Deviation 0 |
Secondary
Time to First Analgesic Request
Time frame: 72 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control Group) | Time to First Analgesic Request | 414 minutes | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Time to First Analgesic Request | 1043 minutes | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Time to First Analgesic Request | 0 minutes | Standard Deviation 0 |
Secondary
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
Total narcotic consumption in morphine equivalents (in milligrams) for 12, 24 and 48 hours after surgery was calculated.
Time frame: 12,24,48 hours post surgery
Population: Data were not collected at 12 hours post surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Control Group) | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 48 hours | 25 milligrams | Standard Deviation 0 |
| Group 1 (Control Group) | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 24 hours | 12.5 milligrams | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 24 hours | 12.5 milligrams | Standard Deviation 0 |
| Group 2(Bupivacaine Hydrochloride Group) | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 48 hours | 12.5 milligrams | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 24 hours | 0 milligrams | Standard Deviation 0 |
| Group 3 (Ropivacaine Hydrochloride Group) | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 48 hours | 0 milligrams | Standard Deviation 0 |
| Unknown | Total Narcotic Consumption in Morphine Equivalents (in Milligrams) | 12 hours | — milligrams | — |