Quadratus Lumborum Block Type 2 Versus Posterior Transversus Abdominus Plane Block

NCT ID: NCT04773730

Last Updated: 2023-06-06

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2023-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This patient population are at risk of adverse effects secondary to inadequate pain management such as inadequate maternal bonding and late ambulation.

Regional analgesia is preferred due to their opioid sparing effects and reduction in related adverse effects but the analgesia from these blocks is not known which one is superior to the other in the context of cesarean section

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of this study is to compare the effect of posterior transversus abdominus plane block and quadratus lumborum type 2 for cesarean delivery.

The transversus abdominus plane(TAP) block provides sensory block from T6 to L1 for lower abdominal surgeries.

Quadratous lumborum type 2 block, the injection is posterior to the quadratus lumborum muscle. This method has the advantage of a more superficial point of injection with better ultrasonographic resolution.

Only one RCT was done in this context by Kalpana Verma and his colleagues comparing quadratus lumborum type 2 and posterior transversus abdominus plane block. That shows marked discrepancy with time to first analgesic request from the quadratus lumborum block in other abdominal surgeries

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Regional Block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients will be randomly allocated via sealed opaque envelop into 2 groups of 50 patients each; Posterior transversus abdominus block (TAP) group and Quadratus lumborum block type 2 is the second group (QLB)group
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
pain score assessment will be done by an anesthetist who is not involved in randomization or in the anesthetic technique

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Posterior transversus abdominus block

After the surgery end and while the patient in the supine position, with the side to be blocked is elevated

A 12-14 MHz linear array transducer will be placed transversely between the iliac crest and costal margin then slided from medial-lateral to visualize the posterior most part of the external oblique, internal oblique, and transversus abdominus muscles

Then 20 mL of bupivacaine0.25% will be injected between the transverses abdominus muscle and the fascia deep to the internal oblique muscle

The same steps will be repeated on the other side

Group Type ACTIVE_COMPARATOR

Posterior transversus abdominus plane block

Intervention Type PROCEDURE

Twenty mL of bupivacaine 0.25% will be injected in the plane between the transverses abdominus muscle and the fascia deep to the internal oblique muscle on each side

Quadratus lumborum block type 2

After the surgery end and while the patient in the supine position, with the side to be blocked is elevated

A2-5 MHz curved array transducer will be placed at the level of the antero-superior iliac spine then the external oblique muscle will be followed posterolaterally until its posterior border will be visualized The probe will be tilted down to identify a bright hyperechoic line After that 20 mL of bupivacaine 0.25% will be injected under direct visualization on the posterior surface of quadrates lumborum muscle

The same steps will be repeated on the other side

Group Type ACTIVE_COMPARATOR

Quadratus lumborum block type 2

Intervention Type PROCEDURE

Twenty mL of bupivacaine 0.25% will be injected on the posterior surface of quadrates lumborum muscle on each side

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Posterior transversus abdominus plane block

Twenty mL of bupivacaine 0.25% will be injected in the plane between the transverses abdominus muscle and the fascia deep to the internal oblique muscle on each side

Intervention Type PROCEDURE

Quadratus lumborum block type 2

Twenty mL of bupivacaine 0.25% will be injected on the posterior surface of quadrates lumborum muscle on each side

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* American Society of Anesthesiologists physical status II parturient.
* Singleton pregnancies with a gestation of at least 37 weeks.
* Patients undergoing spinal anesthesia for cesarean deliveryvia a Pfannenstiel incision with exteriorization of the uterus.

Exclusion Criteria

* Age \< 19 or \> 40 years.
* Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥35 kg/m2.
* Inability to comprehend or participatein pain scoring system.
* Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
* Hypersensitivity to any drugused in the study.
* Hypertensive disorders of pregnancy.
* Renal impairment or other contraindication to non-steroidal anti-inflammatory drugs.
* Significant cardiovascular, renal or hepatic abnormalities.
* Patients with history of opoid intake, drug abusers, psychiatric patients.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

maha abou-zeid

Assistant professor of anesthesia and surgical intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maha Ahmed Abozeid, MD

Role: STUDY_DIRECTOR

Faculty of Medicine - Mansoura University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

El Mansoura

El Mansoura, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

regional block

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.