Bilateral Ultrasound Guided Quadratus Lumborum Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response in Abdominal Surgery

Postoperative Pain Clinical Trial

Official title:

Effect of Bilateral Ultrasound Guided Quadratus Lumborum Block Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response Following Major Lower Abdominal Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03958942
• Other study ID #: 255
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: Ahmad M Abd El-Rahman, M.D.
• Phone: 00201149606060
• Email: ahmad23679[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims at comparing the effects of bilateral ultrasound-guided quadratus lumborum block versus lumbar epidural block on postoperative analgesia and inflammatory response following major lower abdominal cancer surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA II, III

• Weight 50 - 85 kg.

• Scheduled for major lower abdominal cancer surgery (radical cystectomy, total abdominal hysterectomy).

Exclusion Criteria:

• Patients with a history of relevant drug allergy.

• Coagulation disorders.

• Opioid dependence.

• Sepsis.

• Local infection at the vicinity of the block site.

• Patients with psychiatric illnesses that would interfere with perception and assessment of pain

Related Conditions & MeSH terms

• Inflammatory Response
• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Ultrasound quadratus lumborum block with bupivacaine 25%
echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle
• lumbar epideural block with bupivacaine 25%
lumbar epidural will be performed for patients in group II using a 16-gauge Touhy epidural needle by a median approach. The T12 - L1 or L1 - L2 interspaces will be chosen for the injection. The epidural space identified by the loss of resistance technique.

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	postoperative pain intensity.	first 24 hours postoperatively
Secondary	postoperative inflammatory response	inflammatory response represented by the levels of: interleukins 1,6, and tumor necrosis factor alpha	first 24 hours postoperatively
Secondary	side effects	sedation, nausea, vomiting, and respiratory depression	first 24 hours postoperatively