Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine Postoperatively

Phase 4

Completed

• Conditions: Abdominal Cancer
• Interventions: Drug: transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine

• Registration Number: NCT02566096
• Lead Sponsor: Assiut University

Brief Summary

This study aims to compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer surgery.

Detailed Description

This randomized study will be approved by the local ethics committee of South Egypt Cancer Institute, Assuit University, Egypt after written informed consent. This study will include approximately 60 ASA I-II cancer patients with age range (18-60) years, weight (50- 85) kg who will be scheduled for lower abdominal cancer surgery (abdominal hysterectomy, oophorectomy and radical cystectomy). Exclude from the study Patients with known drug allergy to study drugs, significant cardiac, respiratory, renal or hepatic disease, coagulation disorders and those with psychiatric illnesses that would interfere with perception and assessment of pain. Preoperatively, patients will be taught how to evaluate their own pain intensity using the Visual Analog Scale (VAS), scored from 0-10 (where 0= no pain and 10=worst pain imaginable).

Patients will be randomly assigned using an online research randomizer into two groups, 30 patients in each group:

Group 1:

30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

Group 2:

30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

Surgery will be performed under standard general anesthesia and ultrasound guided TAP block will be performed before induction of GA.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Status Verified: 2016-03
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

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

Inclusion Criteria

• 60 ASA I-II cancer patients with age range (18-60) years,
• weight (50- 85) kg

Exclusion Criteria

• with patients with known drug allergy to study drugs
• with significant cardiac, respiratory, renal or hepatic disease
• with coagulation disorders
• those with psychiatric illnesses that would interfere with perception and assessment of pain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP with bupivicaine	transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine	30 patients receive ultrasound guided transversus abdominis-plane block (TAP) with local anesthetic 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.
TAP with bupivicaine with morphine	transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine	30 patients receive ultrasound guided transversus abdominis-plane block (TAP) with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

Primary Outcome Measures

Name	Time	Method
The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale	first 24 hours postoperatively	The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale will be assessed postoperatively at baseline, 2, 4, 6, 8, 12, 18, and 24 hours.

Secondary Outcome Measures

Name	Time	Method
the level of sedation by using sedation score	24 hours postoperatively	the level of sedation by using sedation score (awake and alert = 0, quietly awake = 1, asleep but easily roused= 2, deep sleep = 3) will be assessed postoperatively at baseline, 2, 4, 6, 8, 12, 18, and 24 hours.
first request for analgesia in minutes will be observed	firsr 24 hours

Trial Locations

Locations (1)

South Egypt Cancer Instuite; 🇪🇬 Assuit, Egypt