Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block

Not Applicable

• Conditions: Pain
• Interventions: Drug: Dexmedetomidine; Drug: Bupivacaine; Drug: Fentanyl

• Registration Number: NCT04318158
• Lead Sponsor: Beni-Suef University

Brief Summary

The aim and objective of this study is to compare dexmedetomidine and fentanyl as adjuvants to bupivacaine in ultrasound guided TAP block analgesia in patients undergoing radical cystectomy as regarding postoperative analgesic efficacy.

Detailed Description

Radical cystectomy with pelvic lymph node dissection is the gold standard treatment for muscle invasive bladder cancer and is associated with a high risk of complications. Management of the postoperative pain is important to decrease the length of stay in the hospital and the risk of morbidity. Multimodal analgesia management is utilized for pain observed in the postoperative period.As part of a multimodal analgesic regimen, a peripheral nerve block can decrease opioid consumption, providing more effective analgesia with fewer adverse effects.TAP block is a relatively new regional anesthesia technique that provides analgesia to the parietal peritoneum, as well as skin and muscles of the lower anterior abdominal wall. Dexmedetomidine and fentanyl have been used as adjuvants to local anesthetics in different surgeries to provide superior analgesia and to improve the duration of the block.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-20
• Last Update Submitted: 2020-03-20
• Study First Posted: 2020-03-23
• Last Update Posted: 2020-03-23
• Study Start: 2020-04
• Primary Completion: 2021-04
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Both sexes.
• ASA grade I and II.
• Age between 50-70 years.
• Elective open radical cystectomy.

Exclusion Criteria

• Any history or signs of cardiac, hepatic and renal failure.
• Patients with coagulopathy or under anticoagulation therapy.
• Infection near the site of needle insertion.
• Morbid obesity (BMI>40 kg/m2).
• History of allergic reactions to any of the study medications.
• Previous abdominal surgery.
• Patients with any neurological or neuromuscular disorder or history of seizures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group(BD)	Dexmedetomidine	Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.
Group(B)	Bupivacaine	Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side.
Group(BF)	Fentanyl	Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.

Primary Outcome Measures

Name	Time	Method
The time for first rescue analgesia after the TAP block.	first 24 hours after block.	Postoperative analgesia duration.

Secondary Outcome Measures

Name	Time	Method
the total dose of rescue analgesia after TAP bock.	first 24 hours after block.	Postoperative analgesia consumption.
VAS for pain.	0, 2, 4, 6, 12 and 24 hours postoperatively.	Postoperative pain at rest and movement.