Analgesia, Thyroid Disease
Conditions
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.
Interventions
PROCEDUREThyroidectomy
Thyroidectomy performed by the same surgical and anesthesia team
DRUGBupivacaine
bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
DRUGSaline Solution
%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed