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

Assiut University

Status and phase: Completed; Phase 4

Conditions: Abdominal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02566096

229

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

TAP with bupivicaine

Placebo Comparator group

Description:

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.

Treatment:

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

TAP with bupivicaine with morphine

Active Comparator group

Description:

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.

Treatment:

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