Clinical trial NCT04318158: Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block
Official title: A Comparative Study of Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Dexmedetomidine
Fentanyl
Bupivacaine
Transversus Abdominis Plane Block
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The time for first rescue analgesia after the TAP block.
timeFrame: first 24 hours after block.
Secondary outcomes:
measure: the total dose of rescue analgesia after TAP bock.
timeFrame: first 24 hours after block.
measure: VAS for pain.
timeFrame: 0, 2, 4, 6, 12 and 24 hours postoperatively.
Other outcomes:
Locations:
Study officials:
References:
citation: Kassim DY, Mahmoud HE, Fakhry DM, Mansour MA. Comparative study of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing radical cystectomy: a prospective randomised study. BMC Anesthesiol. 2022 Nov 7;22(1):340. doi: 10.1186/s12871-022-01877-1.