Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

Postoperative Pain Clinical Trial

Official title:

Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block for Patient Undergoing Lower Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328299
• Other study ID #: 402
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 11, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TAP-block has been shown to be a safe and effective postoperative analgesia method in a variety of general. Dexmedetomidine is a selective α2 agonist with 8 times more affinity for α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist without respiratory depression. Dexmedetomidine has been focus of interest for its broad spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 24 ASA I-II

• patients (age 18-60 years

• weight 50-89 kg

Exclusion Criteria:

• a known allergy to the study drugs

• significant cardiac

• respiratory, renal or hepatic diseases

• bleeding diathesis

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexmedetomidine
20 ml of 0.5 % bupivacaine plus dexmedetomidine 1 µg•kg-1
• bupivacaine
20 ml of 0.5 % bupivacaine

Locations

Country	Name	City	State
Egypt	South Egypt Cancer instIitute	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure dexmedetomidine level into systemic circulation after local administration	assessment of systemic dexmedetomidine level after local administration in TAP block after 15 minutes after giving the block, 30 min, 45 min, 1hrs, 2hrs, 4hrs and 6	up to 6 hours
Secondary	total dose of IV PCA morphine consumption in the first 24 h postoperative	postoperative morphine consumption	24 hours