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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2021-05-31

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.

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group(B)

Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side.

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

single shot US guided TAP block using 20 ml bupivacaine 0.25%.

Group(BD)

Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.

Group(BF)

Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.

Interventions

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Bupivacaine

single shot US guided TAP block using 20 ml bupivacaine 0.25%.

Intervention Type DRUG

Dexmedetomidine

Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.

Intervention Type DRUG

Fentanyl

Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.

Intervention Type DRUG

Other Intervention Names

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Sunnypivacaine Precedex Fentanyl hameln

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No