Effect of Bupivacaine Application on Postthyroidectomy Pain

Analgesia Clinical Trial

Official title:

Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981095
• Other study ID #: IUCTF-EndSx-2010-01
• 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

• Analgesia
• Thyroid Disease
• Thyroid Diseases

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