Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

NCT ID: NCT03328299

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-11

Study Completion Date

2019-09-01

Brief Summary

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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

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexmedetomidine group

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

bupivacaine group

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

Group Type PLACEBO_COMPARATOR

bupivacaine

Intervention Type DRUG

20 ml of 0.5 % bupivacaine

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

bupivacaine

20 ml of 0.5 % bupivacaine

Intervention Type DRUG

Other Intervention Names

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active group control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Adel El sherif,MD

lecturer of anesthesia , ICU and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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South Egypt Cancer instIitute

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 35035233 (View on PubMed)

Other Identifiers

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402

Identifier Type: -

Identifier Source: org_study_id

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