Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.

Study Overview

• Status: Withdrawn
• Conditions: Morphine; Analgesics, Opioid; Peripheral Nervous System Agents; Analgesics
• Intervention / Treatment: Drug: Saline; Drug: Bupivacaine; Drug: Dexamethasone

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Linden Lee, MD; Phone Number: (713) 500-6200; Email: Linden.O.Lee@uth.tmc.edu
• Study Contact Backup: Name: Ana Lisa Ramirez-Chapman; Phone Number: (713) 566-5971; Email: Ana.L.RamirezChapman@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas health Science Center at Houston
      • Contact: Ana Lisa Ramirez-Chapman; Phone Number: (713) 566-5971; Email: Ana.L.RamirezChapman@uth.tmc.edu
      • Contact: Linden Lee, MD; Phone Number: 713-500-6200; Email: Linden.O.Lee@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• elective or non-elective cesarean delivery on prior day
• pain scores >5/10

Exclusion Criteria:

• BMI >40
• obstructive sleep apnea
• drug abuse
• chronic pain
• chronic opioid use
• abdominal surgeries other than cesarean delivery
• contraindications to neuraxial or regional anesthesia
• received general anesthesia or did not receive neuraxial morphine for cesarean delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Control; 20 milliliters (mL) 0.9% saline on each side	Drug: Saline; 0.9% saline on each side
Experimental: Quadratus Lumborum Block; 20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side	Drug: Bupivacaine; 0.25% bupivacaine (50mg) on each side; Drug: Dexamethasone; 3mg preservative-free dexamethasone on each side

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total opioid consumption	48 hours after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of opioids used		at the time of intervention (one day following cesarean delivery)
Amount of opioids used		6 hours after intervention
Amount of opioids used		12 hours after intervention
Amount of opioids used		24 hours after intervention
Amount of opioids used		48 hours after intervention
Time from quadratus lumborum block until first opioid request		from time of intervention until time of first opioid request (up to 48 hours)
Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	at the time of intervention (one day following cesarean delivery)
Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	at the time of intervention (one day following cesarean delivery)
Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	6 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	6 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	12 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	12 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	24 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	24 hours after intervention
Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	48 hours after intervention
Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	48 hours after intervention
Nausea as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	at the time of intervention (one day following cesarean delivery)
Nausea as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	6 hours after intervention
Nausea as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	12 hours after intervention
Nausea, pruritus and sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	24 hours after intervention
Nausea as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	48 hours after intervention
Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	at the time of intervention (one day following cesarean delivery)
Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	6 hours after intervention
Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	12 hours after intervention
Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	24 hours after intervention
Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	48 hours after intervention
Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	at the time of intervention (one day following cesarean delivery)
Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	6 hours after intervention
Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	12 hours after intervention
Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	24 hours after intervention
Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	48 hours after intervention
Patient satisfaction as measured by the 5-point Likert scale	The 5-point scale ranges from extremely satisfied to not satisfied.	48 hours after intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2022
• Primary Completion (Estimated): June 30, 2022
• Study Completion (Estimated): June 30, 2022

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: bupivacaine; quadratus lumborum block; post-operative pain; cesarean delivery; intrathecal morphine; c-section; post-cesarean analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: HSC-MS-20-0124

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