A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain

NCT ID: NCT04368364

Last Updated: 2022-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-22

Study Completion Date

2020-06-29

Brief Summary

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the purpose of this study is to compare opioid consumption in morphine equivalents between the groups that received postoperative analgesia with intrathecal morphine versus US guided QL blocks versus US guided QL catheters

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1 (Control group)

Group Type ACTIVE_COMPARATOR

Intrathecal morphine sulfate (ITM)

Intervention Type DRUG

Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion

Group 2(Bupivacaine hydrochloride group)

Group Type EXPERIMENTAL

Bupivacaine hydrochloride

Intervention Type DRUG

Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion

Group 3 (ropivacaine hydrochloride group)

Group Type EXPERIMENTAL

ropivacaine hydrochloride

Intervention Type DRUG

Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride

Interventions

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Intrathecal morphine sulfate (ITM)

Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion

Intervention Type DRUG

Bupivacaine hydrochloride

Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion

Intervention Type DRUG

ropivacaine hydrochloride

Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective C section via Pfannenstiel incision
* Living singleton pregnancy
* Gestation week at least 37 weeks
* American Society of Anesthesiologists (ASA) status 1, 2 and 3
* Primary and secondary C sections

Exclusion Criteria

* Chronic pain
* Opioid tolerant patients
* Allergy to drugs used in the study.
* Cognitive dysfunction
* BMI \> 40
* Coagulation disorder
* Local infection
* Inability to tolerate oral medication
* Previous intra-abdominal surgery
* Patients who will receive a combined spinal epidural for their C section
* Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.- local wound infiltration by surgeon)
* Patients who received sedation or general anesthesia during their C section (midazolam, ketamine, fentanyl, propofol, hydromorphone)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Sudipta Sen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sudipta Sen, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Memorial Hermann Hospital TMC

Houston, Texas, United States

Site Status

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-MS-20-0143

Identifier Type: -

Identifier Source: org_study_id

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