Effect of Bupivacaine Application on Postthyroidectomy Pain

Not Applicable

Completed

• Conditions: Thyroid Disease; Analgesia
• Interventions: Procedure: Thyroidectomy; Drug: Saline Solution; Drug: Bupivacaine

• Registration Number: NCT02981095
• Lead Sponsor: Istanbul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-01
• Study Completion: 2011-03
• Status Verified: 2016-11
• Study First Submitted: 2016-11-25
• Study First Submitted QC: 2016-12-01
• Last Update Submitted: 2016-12-01
• Study First Posted: 2016-12-02
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Thyroidectomy	bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Saline	Saline Solution	Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Saline	Thyroidectomy	Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Bupivacaine	Bupivacaine	bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.

Primary Outcome Measures

Name	Time	Method
Post-operative pain in 8 hours after surgery using VAS	8th hour	Evaluation of the pain through the post-operative first 8 hours using VAS

Secondary Outcome Measures

Name	Time	Method
Post-operative pain in in first post-operative day using VAS	1 day	Evaluation of the pain through the first post-operative day using VAS

Trial Locations

Locations (1)

Istanbul University, Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Turkey