Effect of Bupivacaine Application on Postthyroidectomy Pain

December 1, 2016 updated by: Serkan TEKSOZ, Istanbul University

Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • Istanbul University, Cerrahpasa Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine
bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
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.
Placebo Comparator: 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.
Procedure: Thyroidectomy
Thyroidectomy performed by the same surgical and anesthesia team
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain in 8 hours after surgery using VAS
Time Frame: 8th hour
Evaluation of the pain through the post-operative first 8 hours using VAS
8th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain in in first post-operative day using VAS
Time Frame: 1 day
Evaluation of the pain through the first post-operative day using VAS
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Chair: Yusuf BUKEY, Prof. MD, Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 25, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUCTF-EndSx-2010-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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