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

Ultra-sound Guided Bilateral Quadratus Lumborum Block Versus Epidural Block for Postoperative Analgesia 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.

Study Overview

• Status: Completed
• Conditions: Elective Major Abdominal Surgery
• Intervention / Treatment: Other: Thoracic epidural block; Drug: Induction of general anaesthesia with propofol; Drug: Muscle Relaxant; Drug: Maintenance of general anaesthesia; Other: Ultrasound-guided bilateral quadratus lumborum block

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mohammed A Ghanem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracic epidural block; Patients will receive thoracic epidural block following induction of general anaesthesia	Other: 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.; Drug: Induction of general anaesthesia with propofol; propofol: 1.5-2.5mg/Kg; Drug: Muscle Relaxant; Atracurium : 0.5mg/Kg.; Drug: Maintenance of general anaesthesia; Sevoflurane 0.7-1.5 MAC in 40% oxygen
Active Comparator: Bilateral quadratus lumborum block; Patients will receive Ultrasound-guided bilateral quadratus lumborum block following induction of general anaesthesia	Drug: Induction of general anaesthesia with propofol; propofol: 1.5-2.5mg/Kg; Drug: Muscle Relaxant; Atracurium : 0.5mg/Kg.; Drug: Maintenance of general anaesthesia; Sevoflurane 0.7-1.5 MAC in 40% oxygen; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative 24 hours cumulative rescue morphine consumption	For 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of postoperative analgesia	time from performing epidural or quadratus lumborum block till the time for the first rescue morphine request	For 24 hours after surgery
Postoperative pain score at rest	Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)	For 24 hours after surgery
Postoperative pain score on movement	Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)	For 24 hours after surgery
Postoperative pain score on cough	Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)	For 24 hours after surgery
Systolic blood pressure		For 28 hours after induction of anesthesia
Diastolic blood pressure		For 28 hours after induction of anesthesia
Mean blood pressure		For 28 hours after induction of anesthesia
Heart rate		For 28 hours after induction of anesthesia
Degree of postoperative nausea and vomiting	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	For 24 hours after surgery
Pruritis		For 24 hours after surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mona A Hasheesh, MD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): April 9, 2019
• Study Completion (Actual): May 6, 2019

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Hypnotics and Sedatives; Anesthetics; Propofol
• Other Study ID Numbers: MS ∕18.06.187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No