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

NCT ID: NCT04541732

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-05-06

Brief Summary

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.

Detailed Description

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

Conditions

Elective Major Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Thoracic epidural block

Patients will receive thoracic epidural block following induction of general anaesthesia

Group Type: EXPERIMENTAL

Thoracic epidural block

Intervention Type: 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.

Induction of general anaesthesia with propofol

Intervention Type: DRUG

propofol: 1.5-2.5mg/Kg

Muscle Relaxant

Intervention Type: DRUG

Atracurium : 0.5mg/Kg.

Maintenance of general anaesthesia

Intervention Type: DRUG

Sevoflurane 0.7-1.5 MAC in 40% oxygen

Bilateral quadratus lumborum block

Patients will receive Ultrasound-guided bilateral quadratus lumborum block following induction of general anaesthesia

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided bilateral quadratus lumborum block

Intervention Type: 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

Intervention Type: DRUG

propofol: 1.5-2.5mg/Kg

Muscle Relaxant

Intervention Type: DRUG

Atracurium : 0.5mg/Kg.

Maintenance of general anaesthesia

Intervention Type: DRUG

Sevoflurane 0.7-1.5 MAC in 40% oxygen

Interventions

Thoracic epidural block

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.

Intervention Type: OTHER

Ultrasound-guided bilateral quadratus lumborum block

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

Intervention Type: OTHER

Induction of general anaesthesia with propofol

propofol: 1.5-2.5mg/Kg

Intervention Type: DRUG

Muscle Relaxant

Atracurium : 0.5mg/Kg.

Intervention Type: DRUG

Maintenance of general anaesthesia

Sevoflurane 0.7-1.5 MAC in 40% oxygen

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammed A Ghanem, MD

Role: STUDY_DIRECTOR

Associate Professor

Mona A Hasheesh, MD

Role: STUDY_CHAIR

Professor

Locations

Mohammed A Ghanem

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MS ∕18.06.187

Identifier Type: -

Identifier Source: org_study_id