Effect of Bupivacaine Application on Postthyroidectomy Pain

Istanbul University

Status: Completed

Conditions: Analgesia; Thyroid Disease

Treatments: Drug: Saline Solution; Drug: Bupivacaine; Procedure: Thyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02981095

IUCTF-EndSx-2010-01

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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91 participants in 2 patient groups, including a placebo group

Bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Procedure: Thyroidectomy

Saline

Placebo Comparator group

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.

Treatment:

Procedure: Thyroidectomy

Drug: Saline Solution