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Effect of Bupivacaine Application on Postthyroidectomy Pain

NCT ID: NCT02981095

Last Updated: 2016-12-02

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

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Disease Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bupivacaine

bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.

Group Type ACTIVE_COMPARATOR

Thyroidectomy

Intervention Type PROCEDURE

Thyroidectomy performed by the same surgical and anesthesia team

Bupivacaine

Intervention Type DRUG

bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.

Saline

Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.

Group Type PLACEBO_COMPARATOR

Thyroidectomy

Intervention Type PROCEDURE

Thyroidectomy performed by the same surgical and anesthesia team

Saline Solution

Intervention Type DRUG

%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.

Interventions

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Thyroidectomy

Thyroidectomy performed by the same surgical and anesthesia team

Intervention Type PROCEDURE

Bupivacaine

bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Serkan TEKSOZ

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yusuf BUKEY, Prof. MD

Role: STUDY_CHAIR

Istanbul University

Locations

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Istanbul University, Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IUCTF-EndSx-2010-01

Identifier Type: -

Identifier Source: org_study_id