Clinical trial NCT02566096: Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine Postoperatively
Official title: Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine in Patients Undergoing Major Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Cancer
Keywords: major abdominal cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale
timeFrame: first 24 hours postoperatively
Secondary outcomes:
measure: the level of sedation by using sedation score
timeFrame: 24 hours postoperatively
measure: first request for analgesia in minutes will be observed
timeFrame: firsr 24 hours
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer Instuite
Study officials:
References:
citation: El Sherif FA, Mohamed SA, Kamal SM. The effect of morphine added to bupivacaine in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia following lower abdominal cancer surgery, a randomized controlled study. J Clin Anesth. 2017 Jun;39:4-9. doi: 10.1016/j.jclinane.2017.03.009. Epub 2017 Mar 10.