Effect of Bupivacaine Application on Postthyroidectomy Pain

Study Overview
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Brief Summary
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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.

Official Title
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Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience

Conditions
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Thyroid Disease, Analgesia

Intervention / Treatment
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* Procedure: Thyroidectomy
* Drug: Bupivacaine
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation. | Procedure: Thyroidectomy<br>* Thyroidectomy performed by the same surgical and anesthesia team<br>Drug: Bupivacaine<br>* bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.<br>|
| Placebo Comparator: Saline<br>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<br>* Thyroidectomy performed by the same surgical and anesthesia team<br>Drug: Saline Solution<br>* %0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |