Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

NCT ID: NCT04397458

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-06-30

Brief Summary

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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

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Conditions

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Morphine Analgesics Analgesics, Opioid Peripheral Nervous System Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sham Control

20 milliliters (mL) 0.9% saline on each side

Group Type SHAM_COMPARATOR

Saline

Intervention Type DRUG

0.9% saline on each side

Quadratus Lumborum Block

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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

0.25% bupivacaine (50mg) on each side

Dexamethasone

Intervention Type DRUG

3mg preservative-free dexamethasone on each side

Interventions

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Saline

0.9% saline on each side

Intervention Type DRUG

Bupivacaine

0.25% bupivacaine (50mg) on each side

Intervention Type DRUG

Dexamethasone

3mg preservative-free dexamethasone on each side

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Maya Suresh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linden Lee, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-20-0124

Identifier Type: -

Identifier Source: org_study_id

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