Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: bupivacaine; Drug: Dexmedetomidine

• Registration Number: NCT03328299
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-01
• Study Start: 2017-11-11
• Primary Completion: 2018-12-01
• Study Completion: 2019-09-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 24 ASA I-II
• patients (age 18-60 years
• weight 50-89 kg

Read More

Exclusion Criteria

• a known allergy to the study drugs
• significant cardiac
• respiratory, renal or hepatic diseases
• bleeding diathesis

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine group	bupivacaine	patients will given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine
Dexmedetomidine group	Dexmedetomidine	patients were given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine + dexmedetomidine 1 μg•kg-1 diluted in 20 ml saline

Primary Outcome Measures

Name	Time	Method
measure dexmedetomidine level into systemic circulation after local administration	up to 6 hours	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

Secondary Outcome Measures

Name	Time	Method
total dose of IV PCA morphine consumption in the first 24 h postoperative	24 hours	postoperative morphine consumption

Trial Locations

Locations (1)

South Egypt Cancer instIitute; 🇪🇬 Assuit, Egypt