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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318158
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Dina Mahmoud Fakhry, 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine Drug: Dexmedetomidine Drug: Fentanyl Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group(B)
Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side.
Drug: Bupivacaine
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.
Drug: Dexmedetomidine
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.
Drug: Fentanyl
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 :
  1. The time for first rescue analgesia after the TAP block. [ Time Frame: first 24 hours after block. ]
    Postoperative analgesia duration.


Secondary Outcome Measures :
  1. the total dose of rescue analgesia after TAP bock. [ Time Frame: first 24 hours after block. ]
    Postoperative analgesia consumption.

  2. VAS for pain. [ Time Frame: 0, 2, 4, 6, 12 and 24 hours postoperatively. ]
    Postoperative pain at rest and movement.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Dina Mahmoud Fakhry, Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management, Beni-Suef University
ClinicalTrials.gov Identifier: NCT04318158    
Other Study ID Numbers: FMBSUREC/08032020/Fakhry
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dina Mahmoud Fakhry, Beni-Suef University:
Dexmedetomidine
Fentanyl
Bupivacaine
Transversus Abdominis Plane Block
Additional relevant MeSH terms:
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Fentanyl
Dexmedetomidine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General