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

Abdominal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566096
• Other study ID #: 229
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2015
• Last updated: July 14, 2016
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal Cancer
• Abdominal Neoplasms

Intervention

Drug:
• transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine
compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine with morphine in patients undergoing major abdominal cancer surgery.

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Instuite	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale	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.	first 24 hours postoperatively	Yes
Secondary	the level of sedation by using sedation score	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.	24 hours postoperatively	Yes
Secondary	first request for analgesia in minutes will be observed		firsr 24 hours	Yes