TAP: Postoperative Analgesic Effects of Dexmedetomidine for Transversus Abdominis Plane Block

Sponsor

TC Erciyes University (Other)

Overall Status

Completed

CT.gov ID

NCT02064530

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Bupivacaine Drug: Dexmedetomidine Drug: serum physiologic	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Postoperative Analgesic Effects of Dexmedetomidine Added to Bupivacaine for Transversus Abdominis Plane Block for Lower Abdominal Surgery

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bupivacaine 0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on TAP block	Drug: Bupivacaine 21 ml 0.5 %bupivacaine is applied interfasially Other Names: marcaine
Active Comparator: dexmedetomidine 100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on TAP block	Drug: Dexmedetomidine 1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially Other Names: precedex
Sham Comparator: serum phsyologic 0,9% 21 ml serum physiologic	Drug: serum physiologic 21 ml serum physiologic is applied interfasially

Arm

Intervention/Treatment

Active Comparator: bupivacaine

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

Drug: Bupivacaine

21 ml 0.5 %bupivacaine is applied interfasially

Other Names:

marcaine

Active Comparator: dexmedetomidine

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

Drug: Dexmedetomidine

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

Other Names:

precedex

Sham Comparator: serum phsyologic

0,9% 21 ml serum physiologic

Drug: serum physiologic

21 ml serum physiologic is applied interfasially

Outcome Measures

Primary Outcome Measures

opioid consumption [postoperative 1 day]
patient controlled analgesia

Secondary Outcome Measures

visual analog scale [postoperative 1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erciyes universty	Kayseri	Melikgazi	Turkey	38039

Sponsors and Collaborators

TC Erciyes University

Investigators

Study Director: Recep Aksu, assoc. prof., Erciyes universty medicine faculty
Principal Investigator: Gülçin Patmano, resident, Erciyes universty medicine faculty