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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02981095
Other study ID # IUCTF-EndSx-2010-01
Secondary ID
Status Completed
Phase N/A
First received November 25, 2016
Last updated December 1, 2016
Start date January 2010
Est. completion date March 2011

Study information

Verified date November 2016
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics CommitteeTurkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

Investigators aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical, randomized study.

Pain assessment was performed with the visual analog score (VAS). Participants were pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One group received a 10 ml of bupivacaine solution while the other group was treated with the same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total thyroidectomy procedure. All participants were anesthetized and operated with the same anesthesia and surgical team.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date March 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects need to be operated for thyroid diseases

Exclusion Criteria:

- History of previous thyroid disease,

- History of previous neck operations,

- Hypersensitivity to the drugs that were used in the study protocol,

- Spinal bone disease,

- Depression,

- Kidney failure,

- Heart failure,

- Liver failure,

- Pulmonary failure,

- Mental retardation,

- Subjects not able to ascertain pain scoring with the visual analog score (VAS),

- Patients with American Society of Anesthesiologists (ASA) scores III or higher,

- Expected airway difficulty according to Mallampati scores,

- Sedative, steroid, and chronic analgesic drug users,

- Alcoholics

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Thyroidectomy
Thyroidectomy performed by the same surgical and anesthesia team
Drug:
Bupivacaine
bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Saline Solution
%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.

Locations

Country Name City State
Turkey Istanbul University, Cerrahpasa Medical Faculty Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative pain in 8 hours after surgery using VAS Evaluation of the pain through the post-operative first 8 hours using VAS 8th hour No
Secondary Post-operative pain in in first post-operative day using VAS Evaluation of the pain through the first post-operative day using VAS 1 day No
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