Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines

Postoperative Pain Clinical Trial

Official title:

Effect of Rectus Sheath Block on Opioid Consumption and Serum Level of TNF-α and IL-6 After Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074097
• Other study ID #: 17100391
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2017
• Last updated: February 21, 2018
• Start date: March 5, 2015
• Est. completion date: April 28, 2016

Study information

• Verified date: February 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 28, 2016
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Hong JY, Lim KT. Effect of preemptive epidural analgesia on cytokine response and postoperative pain in laparoscopic radical hysterectomy for cervical cancer. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):44-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative opioid consumption	study the effect of RSB on cumulative opioid consumption at 24 hours	24 hours postoperative
Secondary	Numerical rating scale (NRS)	evaluate postoperative pain intensity by NRS	24 hours postoperative
Secondary	time to first anlgesic request	the first time receiving IV-PCA bolus injection	24 hours postoperative
Secondary	serum levels of TNF-a	Proinflamatory cytokines	at 24 hours postoperative
Secondary	Serum level of IL-6	Proinflamatory cytokines	at 24 hours postoperative