Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Bupivacaine 0.25%

• Registration Number: NCT03074097
• Lead Sponsor: Assiut University

Brief Summary

Good quality of postoperative analgesia would lead to attenuate or prevent the adverse effects on the common functions of the immune system. We compared the effect of epidural analgesia versus rectus sheath block on postoperative pain and proinflammatory cytokines following malignant urological surgery.

Detailed Description

Study groups: 60 patients were included in the study randomly allocated into two groups of 30 patients. Rectus sheath group (RSB): Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia. Control group: the patients did not receive any intervention after anaesthesia induction.

Study Timeline

• Study Start: 2015-03-05
• Primary Completion: 2016-02-01
• Study Completion: 2016-04-28
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-08
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Male patients their age over 40 years, classified ASA I, II or III, undergoing radical resection of cancer prostate, through midline abdominal incision under general anaesthesia.

Exclusion criteria:

Contraindications to rectus sheath block as patient refusal, coagulopathy, local infection and allergy to bupivacaine. Planned transverse or oblique abdominal incision, extensive existing midline abdominal scarring or pre-existing chronic abdominal pain.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectus Sheath	Bupivacaine 0.25%	Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia

Primary Outcome Measures

Name	Time	Method
cumulative opioid consumption	24 hours postoperative	study the effect of RSB on cumulative opioid consumption at 24 hours

Secondary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS)	24 hours postoperative	evaluate postoperative pain intensity by NRS
serum levels of TNF-α	at 24 hours postoperative	Proinflamatory cytokines
Serum level of IL-6	at 24 hours postoperative	Proinflamatory cytokines
time to first anlgesic request	24 hours postoperative	the first time receiving IV-PCA bolus injection

Trial Locations

Locations (1)

Assiut university faculty of medicine; 🇪🇬 Assiut, Egypt