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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02064530
Other study ID # 2014/37
Secondary ID
Status Completed
Phase Phase 4
First received February 14, 2014
Last updated September 11, 2015
Start date February 2014
Est. completion date September 2015

Study information

Verified date September 2015
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine
21 ml 0.5 %bupivacaine is applied interfasially
Dexmedetomidine
1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially
serum physiologic
21 ml serum physiologic is applied interfasially

Locations

Country Name City State
Turkey Erciyes universty Kayseri Melikgazi

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary opioid consumption patient controlled analgesia postoperative 1 day No
Secondary visual analog scale postoperative 1 day No
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