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Clinical Trials/NCT02566096
NCT02566096
Completed
Phase 4

Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine in Patients Undergoing Major Abdominal Cancer Surgery

Assiut University1 site in 1 country60 target enrollmentSeptember 2015

Overview

Phase
Phase 4
Intervention
transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine
Conditions
Abdominal Cancer
Sponsor
Assiut University
Enrollment
60
Locations
1
Primary Endpoint
The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatma Adel El sherif

Lecturer

Assiut University

Eligibility Criteria

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.

Arms & Interventions

TAP with bupivicaine

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.

Intervention: transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine

TAP with bupivicaine with 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.

Intervention: transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine

Outcomes

Primary Outcomes

The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale

Time Frame: 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 Outcomes

  • the level of sedation by using sedation score(24 hours postoperatively)
  • first request for analgesia in minutes will be observed(firsr 24 hours)

Study Sites (1)

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