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

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

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

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Intrathecal morphine sulfate (ITM); Drug: Bupivacaine hydrochloride; Drug: ropivacaine hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital TMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1 (Control group)	Drug: Intrathecal morphine sulfate (ITM); Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
EXPERIMENTAL: Group 2(Bupivacaine hydrochloride group)	Drug: Bupivacaine hydrochloride; Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
EXPERIMENTAL: Group 3 (ropivacaine hydrochloride group)	Drug: ropivacaine hydrochloride; Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sudipta Sen, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2020
• Primary Completion (ACTUAL): June 29, 2020
• Study Completion (ACTUAL): June 29, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (ACTUAL): April 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: post c section pain; pain control after baby; nerve block for post delivery pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Ropivacaine; Morphine
• Other Study ID Numbers: HSC-MS-20-0143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No