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

NCT04541732 | Completed DMC

• 1 other identifier: MS ∕18.06.187
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative 24 hours cumulative rescue morphine consumption

  For 24 hours after surgery

Secondary Outcomes (10)

• The duration of postoperative analgesia

  For 24 hours after surgery

• Postoperative pain score at rest

  For 24 hours after surgery

• Postoperative pain score on movement

  For 24 hours after surgery

• Postoperative pain score on cough

  For 24 hours after surgery

• Systolic blood pressure

  For 28 hours after induction of anesthesia

Study Arms (2)

Thoracic epidural block

EXPERIMENTAL

Patients will receive thoracic epidural block following induction of general anaesthesia

Other: Thoracic epidural block; Drug: Induction of general anaesthesia with propofol; Drug: Muscle Relaxant; Drug: Maintenance of general anaesthesia

Bilateral quadratus lumborum block

ACTIVE COMPARATOR

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

Other: Ultrasound-guided bilateral quadratus lumborum block; Drug: Induction of general anaesthesia with propofol; Drug: Muscle Relaxant; Drug: Maintenance of general anaesthesia

Interventions

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.

Thoracic epidural block

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

Bilateral quadratus lumborum block

Induction of general anaesthesia with propofol DRUG

propofol: 1.5-2.5mg/Kg

Bilateral quadratus lumborum block; Thoracic epidural block

Muscle Relaxant DRUG

Atracurium : 0.5mg/Kg.

Bilateral quadratus lumborum block; Thoracic epidural block

Maintenance of general anaesthesia DRUG

Sevoflurane 0.7-1.5 MAC in 40% oxygen

Bilateral quadratus lumborum block; Thoracic epidural block

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mohammed A Ghanem

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mohammed A Ghanem, MD

  Associate Professor

  STUDY DIRECTOR

• Mona A Hasheesh, MD

  Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind study

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 9, 2020
• Study Start: January 1, 2019
• Primary Completion: April 9, 2019
• Study Completion: May 6, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

EG (1)