Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04397458

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morphine Analgesics Analgesics, Opioid Peripheral Nervous System Agents	Drug: Saline Drug: Bupivacaine Drug: Dexamethasone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Total opioid consumption [48 hours after intervention]

Secondary Outcome Measures

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) [at the time of intervention (one day following cesarean delivery)]
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Pain as measured by an 11-point verbal pain score (with movement) [at the time of intervention (one day following cesarean delivery)]
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Pain as measured by an 11-point verbal pain score (at rest) [6 hours after intervention]
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Pain as measured by an 11-point verbal pain score (with movement) [6 hours after intervention]
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Pain as measured by an 11-point verbal pain score (at rest) [12 hours after intervention]
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Pain as measured by an 11-point verbal pain score (with movement) [12 hours after intervention]
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Pain as measured by an 11-point verbal pain score (at rest) [24 hours after intervention]
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
Pain as measured by an 11-point verbal pain score (with movement) [24 hours after intervention]
The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.
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.
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 as measured by a 3-point scale [at the time of intervention (one day following cesarean delivery)]
This is measured categorically as none, mild, or moderate-severe.
Nausea as measured by a 3-point scale [6 hours after intervention]
This is measured categorically as none, mild, or moderate-severe.
Nausea as measured by a 3-point scale [12 hours after intervention]
This is measured categorically as none, mild, or moderate-severe.
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.
Nausea as measured by a 3-point scale [48 hours after intervention]
This is measured categorically as none, mild, or moderate-severe.
Pruritus as measured by a 3-point scale [at the time of intervention (one day following cesarean delivery)]
This is measured categorically as none, mild, or moderate-severe.
Pruritus as measured by a 3-point scale [6 hours after intervention]
This is measured categorically as none, mild, or moderate-severe.
Pruritus as measured by a 3-point scale [12 hours after intervention]
This is measured categorically as none, mild, or moderate-severe.
Pruritus as measured by a 3-point scale [24 hours after intervention]
This is measured categorically as none, mild, or moderate-severe.
Pruritus as measured by a 3-point scale [48 hours after intervention]
This is measured categorically as none, mild, or moderate-severe.
Sedation as measured by a 3-point scale [at the time of intervention (one day following cesarean delivery)]
This is measured categorically as none, mild, or moderate-severe.
Sedation as measured by a 3-point scale [6 hours after intervention]
This is measured categorically as none, mild, or moderate-severe.
Sedation as measured by a 3-point scale [12 hours after intervention]
This is measured categorically as none, mild, or moderate-severe.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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