Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block
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|ClinicalTrials.gov Identifier: NCT04318158|
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Information provided by (Responsible Party):
Dina Mahmoud Fakhry, Beni-Suef University
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Bupivacaine Drug: Dexmedetomidine Drug: Fentanyl||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||May 2021|
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side.
single shot US guided TAP block using 20 ml bupivacaine 0.25%.
Other Name: Sunnypivacaine
Active Comparator: Group(BD)
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.
Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.
Other Name: Precedex
Active Comparator: Group(BF)
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.
Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.
Other Name: Fentanyl hameln
Primary Outcome Measures :
- The time for first rescue analgesia after the TAP block. [ Time Frame: first 24 hours after block. ]Postoperative analgesia duration.
Secondary Outcome Measures :
- the total dose of rescue analgesia after TAP bock. [ Time Frame: first 24 hours after block. ]Postoperative analgesia consumption.
- VAS for pain. [ Time Frame: 0, 2, 4, 6, 12 and 24 hours postoperatively. ]Postoperative pain at rest and movement.
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