Effect of Bupivacaine Application on Postthyroidectomy Pain

NCT02981095 | Completed

• 1 other identifier: IUCTF-EndSx-2010-01
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Disease; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Post-operative pain in in first post-operative day using VAS

  1 day

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

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

Procedure: Thyroidectomy; Drug: Bupivacaine

Saline

PLACEBO COMPARATOR

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; Drug: Saline Solution

Interventions

Thyroidectomy PROCEDURE

Thyroidectomy performed by the same surgical and anesthesia team

Bupivacaine; Saline

Bupivacaine DRUG

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

Bupivacaine

Saline Solution DRUG

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

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects need to be operated for thyroid diseases

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid Diseases; Agnosia

Interventions

Thyroidectomy; Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yusuf BUKEY, Prof. MD

  Istanbul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 2, 2016
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)