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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparative Study of Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Radical Cystectomy

Conditions
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Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Dexmedetomidine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group(B)<br>Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side. | Drug: Bupivacaine<br>* single shot US guided TAP block using 20 ml bupivacaine 0.25%.<br>* Other names: Sunnypivacaine;|
| Active Comparator: Group(BD)<br>Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side. | Drug: Dexmedetomidine<br>* Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.<br>* Other names: Precedex;|
| Active Comparator: Group(BF)<br>Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side. | Drug: Fentanyl<br>* Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.<br>* Other names: Fentanyl hameln;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time for first rescue analgesia after the TAP block. | Postoperative analgesia duration. | first 24 hours after block. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total dose of rescue analgesia after TAP bock. | Postoperative analgesia consumption. | first 24 hours after block. | 
| VAS for pain. | Postoperative pain at rest and movement. | 0, 2, 4, 6, 12 and 24 hours postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Fentanyl, Bupivacaine, Transversus Abdominis Plane Block