Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

NCT04397458 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: HSC-MS-20-0124
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Morphine; Analgesics; Analgesics, Opioid; Peripheral Nervous System Agents

Keywords

quadratus lumborum block; bupivacaine; cesarean delivery; c-section; intrathecal morphine; post-operative pain; post-cesarean analgesia

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  48 hours after intervention

Secondary Outcomes (32)

• 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

Study Arms (2)

Sham Control

SHAM COMPARATOR

20 milliliters (mL) 0.9% saline on each side

Drug: Saline

Quadratus Lumborum Block

EXPERIMENTAL

20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side

Drug: Bupivacaine; Drug: Dexamethasone

Interventions

Saline DRUG

0.9% saline on each side

Sham Control

Bupivacaine DRUG

0.25% bupivacaine (50mg) on each side

Quadratus Lumborum Block

Dexamethasone DRUG

3mg preservative-free dexamethasone on each side

Quadratus Lumborum Block

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride; Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Linden Lee, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 21, 2020
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)