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

Elective Major Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541732
• Other study ID #: MS /18.06.187
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: May 6, 2019

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 6, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Elective Major Abdominal Surgery

Intervention

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.
• 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

Drug:
• Induction of general anaesthesia with propofol
propofol: 1.5-2.5mg/Kg
• Muscle Relaxant
Atracurium : 0.5mg/Kg.
• Maintenance of general anaesthesia
Sevoflurane 0.7-1.5 MAC in 40% oxygen

Locations

Country	Name	City	State
Egypt	Mohammed A Ghanem	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative 24 hours cumulative rescue morphine consumption		For 24 hours after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Systolic blood pressure		For 28 hours after induction of anesthesia
Secondary	Diastolic blood pressure		For 28 hours after induction of anesthesia
Secondary	Mean blood pressure		For 28 hours after induction of anesthesia
Secondary	Heart rate		For 28 hours after induction of anesthesia
Secondary	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
Secondary	Pruritis		For 24 hours after surgery