Postoperative Analgesic Effects of Dexmedetomidine for Transversus Abdominis Plane Block

NCT ID: NCT02064530

Last Updated: 2015-09-14

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

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

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the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added to bupivacaine on TAP block in patients undergoing lower abdominal surgery.

Detailed Description

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TAP block is being used a method of multimodal balanced analgesia reduces postoperative pain, opioid requirement after surgery and adverse effect of opioid such as sedation, nausea vomiting and ileus. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bupivacaine

0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on TAP block

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

21 ml 0.5 %bupivacaine is applied interfasially

dexmedetomidine

100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on TAP block

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially

serum phsyologic

0,9% 21 ml serum physiologic

Group Type SHAM_COMPARATOR

serum physiologic

Intervention Type DRUG

21 ml serum physiologic is applied interfasially

Interventions

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Bupivacaine

21 ml 0.5 %bupivacaine is applied interfasially

Intervention Type DRUG

Dexmedetomidine

1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially

Intervention Type DRUG

serum physiologic

21 ml serum physiologic is applied interfasially

Intervention Type DRUG

Other Intervention Names

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marcaine precedex

Eligibility Criteria

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Inclusion Criteria

* ASA 1-2
* 18-65 aged
* patient undergoing lower abdominal surgery

Exclusion Criteria

* chronic opioid consumption
* bupivacaine and dexmedetomidine allergies
* coagulopathy
* infection at the needle insertion side
* chronic liver and kidney disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Recep Aksu

associated prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Recep Aksu, assoc. prof.

Role: STUDY_DIRECTOR

Erciyes universty medicine faculty

Gülçin Patmano, resident

Role: PRINCIPAL_INVESTIGATOR

Erciyes universty medicine faculty

Locations

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Erciyes universty

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2014/37

Identifier Type: -

Identifier Source: org_study_id

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