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Completed

NCT Number: NCT04773730

Quadratus Lumborum Block Type 2 Versus Posterior Transversus Abdominus Plane Block

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

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Key information

Conditions

Regional Block

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

El Mansoura

El Mansoura, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. The analgesic duration

    Time frame: within 24 hours after the surgery

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

Secondary outcomes

  1. Postoperative pain at rest

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

    100 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and hundred indicates the worst possible pain

  2. Postoperative pain on movement (attempted hip flexion) or coughing

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

    100 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and hundred indicates the worst possible pain

  3. Patient satisfaction

    Time frame: 24 hours after surgery

    poor= 1, fair = 2, good = 3, excellent = 4

  4. Heart rate

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

    beat per minute

  5. Non-invasive blood pressure

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

    mmHg

  6. Total postoperative analgesic consumption of of ketolac, paracetamol and fentanyl

    Time frame: within the first 24 hours after surgery

    Patients with visual analog scale more than 30 will receive 30 mg of intravenous ketolac in addition to 1gm paracetamol which will be repeated every 8 hours intravenous infusion of every 8 hours. Intravenous administration of fentanyl bolus doses of 0.5 µg per kg per dose will be given if the visual analog scale remains more than 30

  7. Postoperative nausea and vomiting

    Time frame: within 24 hours after surgery

    0= none, 1= mild, 2= moderate and 3= sever

  8. Postoperative lower limb weakness

    Time frame: within 24 hours after surgery

    reported by the patient during her first walk after surgery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

A Comparative Study Between Quadratus Lumborum Block Type 2 and Posterior Transversus Abdominus Plane Block for Analgesia After Cesarean Delivery Under Spinal Anesthesia

Acronym: quadratus

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 26, 2021
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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