Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

Phase 4

Withdrawn

• Conditions: Morphine; Analgesics; Analgesics, Opioid; Peripheral Nervous System Agents
• Interventions: Drug: Saline; Drug: Bupivacaine; Drug: Dexamethasone

• Registration Number: NCT04397458
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Study Start: 2022-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Control	Saline	20 milliliters (mL) 0.9% saline on each side
Quadratus Lumborum Block	Bupivacaine	20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side
Quadratus Lumborum Block	Dexamethasone	20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side

Primary Outcome Measures

Name	Time	Method
Total opioid consumption	48 hours after intervention

Secondary Outcome Measures

Name	Time	Method
Pain as measured by an 11-point verbal pain score (at rest)	48 hours after intervention	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Pruritus as measured by a 3-point scale	48 hours after intervention	This is measured categorically as none, mild, or moderate-severe.
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 (with movement)	48 hours after intervention	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Nausea, pruritus and sedation as measured by a 3-point scale	24 hours after intervention	This is measured categorically as none, mild, or moderate-severe.
Sedation as measured by a 3-point scale	48 hours after intervention	This is measured categorically as none, mild, or moderate-severe.
Amount of opioids used	48 hours after intervention
Nausea as measured by a 3-point scale	48 hours after intervention	This is measured categorically as none, mild, or moderate-severe.
Patient satisfaction as measured by the 5-point Likert scale	48 hours after intervention	The 5-point scale ranges from extremely satisfied to not satisfied.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States