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Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Dexmedetomidine

bupivacaine

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

South Egypt Cancer instIitute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine group

bupivacaine group

Arm Description

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

patients will given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

total dose of IV PCA morphine consumption in the first 24 h postoperative

postoperative morphine consumption

Full Information

NCT ID

NCT03328299

First Posted

October 30, 2017

Last Updated

October 21, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03328299

Brief Title

Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

November 11, 2017 (Actual)

Primary Completion Date

December 1, 2018 (Actual)

Study Completion Date

September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine group

Arm Type

Active Comparator

Arm Description

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

Arm Title

bupivacaine group

Arm Type

Placebo Comparator

Arm Description

patients will given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

active group

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

bupivacaine

Other Intervention Name(s)

control

Intervention Description

20 ml of 0.5 % bupivacaine

Primary Outcome Measure Information:

Title

measure dexmedetomidine level into systemic circulation after local administration

Description

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

Time Frame

up to 6 hours

Secondary Outcome Measure Information:

Title

total dose of IV PCA morphine consumption in the first 24 h postoperative

Description

postoperative morphine consumption

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

South Egypt Cancer instIitute

City

Assuit

ZIP/Postal Code

171516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35035233

Citation

El Sherif FA, Abdel-Ghaffar H, Othman A, Mohamed S, Omran M, Shouman S, Hassan N, Allam A, Hassan S. Pharmacokinetics and Pharmacodynamics of Dexmedetomidine Administered as an Adjunct to Bupivacaine for Transversus Abdominis Plane Block in Patients Undergoing Lower Abdominal Cancer Surgery. J Pain Res. 2022 Jan 4;15:1-12. doi: 10.2147/JPR.S335806. eCollection 2022.

Results Reference

derived

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Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

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