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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02645903
Other study ID # TAP
Secondary ID
Status Completed
Phase Phase 4
First received December 24, 2015
Last updated January 5, 2016
Start date May 2015
Est. completion date October 2015

Study information

Verified date January 2016
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

Living donor organ transplantation has increased in recent years due to an increased need for organs. The objective of this study was to investigate the effects of a TAP block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal incision was used.


Description:

This prospective randomized controlled double-blinded study was conducted with 50 liver transplantation donors between 18-65 years who were scheduled to undergo right hepatectomy surgery. Cases to whom TAP block with ultrasound was applied after standard general anesthesia were determined as Group 1 and cases to whom only standard general anesthesia was applied, were determined as Group 2.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Liver transplantation donors

Exclusion Criteria:

- Patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Transversus Abdominis Plane Block
Cases to whom used bupivacaine with ultrasound guided transversus abdominis plane block was applied after standard general anesthesia were determined as Group 1
standard general anesthesia
Cases to whom applied alone standard general anesthesia were determined as Group 2

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

References & Publications (1)

Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain scores (at movement and at rest) Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain). postoperatively at 24 hours Yes
Secondary morphine consumption morphine consumption were measured in postoperatively 24 hours postoperatively at 24 hours Yes
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