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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Assiut University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the level of sedation by using sedation score [ Time Frame: 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 [ Time Frame: firsr 24 hours ]


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: September 30, 2015
Date Started: September 2015
Date Completion:
Last Updated: July 14, 2016
Last Verified: March 2016