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Completed

NCT Number: NCT04541732

Postoperative Analgesia of Quadratus Lumborum Block Versus Epidural Block After Major Abdominal Surgeries

Acute postoperative pain is an important issue after major abdominal surgeries for which different analgesic modalities have been tried.

Epidural analgesia is the recommended technique to relieve pain after major abdominal surgeries owing to the proved superior analgesia, reduction of opioid-related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility. However, it is not without complications.

Quadratus lumborum block is an ultrasound-guided block that provides patients with both visceral and somatic blockade. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for analgesia after major abdominal surgeries.

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Key information

Conditions

Elective Major Abdominal Surgery

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammed A Ghanem

Al Mansurah, DK, 050, Egypt

About this study

The aim of this study is to detect the feasibility of ultra-sound guided bilateral quadratus lumborum block as a postoperative analgesic modality after major abdominal surgery in comparison to epidural block and its effects on total rescue analgesic requirements in the 1st postoperative 24hours, time to first analgesic request, pain VAS scores, intraoperative and postoperative hemodynamics and postoperative opioid-related side effects.

Under complete aseptic conditions, the patients will receive either thoracic epidural block or bilateral ultrasound-guided quadratus lumborum block after induction of general anaesthesia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status I-III

Exclusion criteria

  • Patient's refusal
  • Significant cardiac, disease.
  • Significant hepatic disease.
  • Significant renal disease (serum creatinine ˃ 1.5 mg/dl).
  • Patients with drug abuse
  • Allergy to study medications
  • Mental disease
  • Communication barrier.
  • Coagulopathy.
  • Local skin infection

Treatment and study plan

thoracic epidural block

Other

Patients who will be subjected to epidural block will be placed in the lateral position then, after sterilization of the skin, 21 G spinal needle will be inserted at T9-T11 intervertebral spaces. The epidural space will be located using the loss of resistance to air technique and a mixture of bupivacaine 0.25% + 50 μ fentanyl targeting T6 level will be injected following induction of general anaesthesia.

Ultrasound-guided bilateral quadratus lumborum block

Other

Patients who will be subjected to major abdominal surgeries will be placed in a supine position with a pillow under their side to obtain an appropriate view of quadratus lumborum muscle. After sterilization of the skin and ultrasound-guided identification of the quadratus lumborum muscle, 20 ml bupivacaine 0.25% + 25μ fentanyl will be injected on each side following induction of general anaesthesia

Induction of general anaesthesia with propofol

Drug

propofol: 1.5-2.5mg/Kg

muscle relaxant

Drug

Atracurium : 0.5mg/Kg.

Maintenance of general anaesthesia

Drug

Sevoflurane 0.7-1.5 MAC in 40% oxygen

Primary outcomes

  1. Postoperative 24 hours cumulative rescue morphine consumption

    Time frame: For 24 hours after surgery

Secondary outcomes

  1. The duration of postoperative analgesia

    Time frame: For 24 hours after surgery

    time from performing epidural or quadratus lumborum block till the time for the first rescue morphine request

  2. Postoperative pain score at rest

    Time frame: For 24 hours after surgery

    Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)

  3. Postoperative pain score on movement

    Time frame: For 24 hours after surgery

    Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)

  4. Postoperative pain score on cough

    Time frame: For 24 hours after surgery

    Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)

  5. Systolic blood pressure

    Time frame: For 28 hours after induction of anesthesia

  6. Diastolic blood pressure

    Time frame: For 28 hours after induction of anesthesia

  7. Mean blood pressure

    Time frame: For 28 hours after induction of anesthesia

  8. Heart rate

    Time frame: For 28 hours after induction of anesthesia

  9. Degree of postoperative nausea and vomiting

    Time frame: For 24 hours after surgery

    Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3). The number of vomiting episodes and the number of antiemetics received will be recorded

  10. Pruritis

    Time frame: For 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Ultra-sound Guided Bilateral Quadratus Lumborum Block Versus Epidural Block for Postoperative Analgesia After Major Abdominal Surgeries.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2020
Registry last updated
Sep 9, 2020

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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