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
- Conditions
- Pain, Postoperative
- Interventions
- Drug: Intrathecal morphine sulfate (ITM)
- Registration Number
- NCT04368364
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 3
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 (Control group) Intrathecal morphine sulfate (ITM) - Group 2(Bupivacaine hydrochloride group) Bupivacaine hydrochloride - Group 3 (ropivacaine hydrochloride group) ropivacaine hydrochloride -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Patient Satisfaction as Assessed by Likert Scale 72 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
Trial Locations
- Locations (2)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Memorial Hermann Hospital TMC
🇺🇸Houston, Texas, United States