A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain

Study Overview
=================
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

Official Title
-----------------
A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks vs Intrathecal Morphine for Post Cesarean Section Pain

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Intrathecal morphine sulfate (ITM)
* Drug: Bupivacaine hydrochloride
* Drug: ropivacaine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (Control group)<br> | Drug: Intrathecal morphine sulfate (ITM)<br>* Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion<br>|
| Experimental: Group 2(Bupivacaine hydrochloride group)<br> | Drug: Bupivacaine hydrochloride<br>* Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion<br>|
| Experimental: Group 3 (ropivacaine hydrochloride group)<br> | Drug: ropivacaine hydrochloride<br>* Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | upto 72 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12,24,48 hours post surgery | 
| 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). | 6, 12, 24, 48 and 72 hours post surgery | 
| 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. | 24, 48 and 72 hours post surgery | 
| 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. | 24, 48 and 72 hours post surgery | 
| 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. | 24, 48 and 72 hours post surgery | 
| 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. | 24, 48 and 72 hours post surgery | 
| 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). | 24 hours post surgery | 
| 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). | 6, 12, 24, 48 and 72 hours post surgery | 
| 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). | 48 hours post surgery | 
| 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). | 72 hours post surgery | 
| Time to First Analgesic Request |  | 72 hours post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post c section pain, pain control after baby, nerve block for post delivery pain