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

Beni-Suef University

Status: Unknown

Conditions: Pain

Treatments: Drug: Bupivacaine; Drug: Dexmedetomidine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT04318158

FMBSUREC/08032020/Fakhry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Group(B)

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine

Group(BD)

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Group(BF)

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl