search
Back to results

Effect of Bupivacaine Application on Postthyroidectomy Pain

Primary Purpose

Thyroid Disease, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thyroidectomy
Bupivacaine
Saline Solution
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University, Cerrahpasa Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine

Saline

Arm Description

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

Outcomes

Primary Outcome Measures

Post-operative pain in 8 hours after surgery using VAS
Evaluation of the pain through the post-operative first 8 hours using VAS

Secondary Outcome Measures

Post-operative pain in in first post-operative day using VAS
Evaluation of the pain through the first post-operative day using VAS

Full Information

First Posted
November 25, 2016
Last Updated
December 1, 2016
Sponsor
Istanbul University
search

1. Study Identification

Unique Protocol Identification Number
NCT02981095
Brief Title
Effect of Bupivacaine Application on Postthyroidectomy Pain
Official Title
Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Disease, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Intervention Type
Procedure
Intervention Name(s)
Thyroidectomy
Intervention Description
Thyroidectomy performed by the same surgical and anesthesia team
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Intervention Description
%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Primary Outcome Measure Information:
Title
Post-operative pain in 8 hours after surgery using VAS
Description
Evaluation of the pain through the post-operative first 8 hours using VAS
Time Frame
8th hour
Secondary Outcome Measure Information:
Title
Post-operative pain in in first post-operative day using VAS
Description
Evaluation of the pain through the first post-operative day using VAS
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yusuf BUKEY, Prof. MD
Organizational Affiliation
Istanbul University
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University, Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Bupivacaine Application on Postthyroidectomy Pain

We'll reach out to this number within 24 hrs