Quadratus Lumborum Block Type 2 Versus Posterior Transversus Abdominus Plane Block

NCT04773730 | Completed

• 1 other identifier: regional block
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Regional Block

Outcome Measures

Primary Outcomes (1)

• The analgesic duration

  the time measured from finishing the block till the first request of analgesia by the patient

  within 24 hours after the surgery

Secondary Outcomes (8)

• Postoperative pain at rest

  immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h

• Postoperative pain on movement (attempted hip flexion) or coughing

  immediately and 1,2,3,4hour at postanesthesia care unit, then in the surgical ward at 6,8,10,12,18 and 24 h

• Patient satisfaction

  24 hours after surgery

• Heart rate

  at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively

• Non-invasive blood pressure

  at 1st, 2nd, 3rd, 4th, 10th, 16th and 22nd hours postoperatively

Study Arms (2)

Posterior transversus abdominus block

ACTIVE COMPARATOR

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

Procedure: Posterior transversus abdominus plane block

Quadratus lumborum block type 2

ACTIVE COMPARATOR

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

Procedure: Quadratus lumborum block type 2

Interventions

Posterior transversus abdominus plane block 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

Posterior transversus abdominus block

Quadratus lumborum block type 2 PROCEDURE

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

Quadratus lumborum block type 2

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Parturient Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

El Mansoura

El Mansoura, Egypt

Location

Study Officials

• Maha Ahmed Abozeid, MD

  Faculty of Medicine - Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: pain score assessment will be done by an anesthetist who is not involved in randomization or in the anesthetic technique
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesia and surgical intensive care

Model Details: 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

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 26, 2021
• Study Start: March 15, 2021
• Primary Completion: August 1, 2022
• Study Completion: June 3, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

EG (1)