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

Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04318158
• Other study ID #: FMBSUREC/08032020/Fakhry
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: May 2021

Study information

• Verified date: March 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Bupivacaine
single shot US guided TAP block using 20 ml bupivacaine 0.25%.
• Dexmedetomidine
Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.
• Fentanyl
Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time for first rescue analgesia after the TAP block.	Postoperative analgesia duration.	first 24 hours after block.
Secondary	the total dose of rescue analgesia after TAP bock.	Postoperative analgesia consumption.	first 24 hours after block.
Secondary	VAS for pain.	Postoperative pain at rest and movement.	0, 2, 4, 6, 12 and 24 hours postoperatively.