Thyroid, Acute Pain, Chronic Pain
Conditions
Keywords
Thyroidectomy, Endoscopy, Ketamine, Acute Pain, Chronic Pain, Postoperative period
Brief summary
In this prospective double-blinded study, The investigators compared acute postoperative pain and rescue analgesic demand during postoperative period after robot thyroidectomy between ketamine and placebo groups.
Detailed description
Robot-assisted endoscopic thyroidectomy has been popularized due to cosmetic advantages. Despite small incisions, robot thyroidectomy did not offer satisfactory reduction in postoperative pain compared to open thyroidectomy. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor blocker and takes some attractive advantages in terms of pain control. When low dose ketamine is perioperatively administrated, opioid sparing effect during postoperative period is reported in various surgical procedures such as spine, thoracic, and gynecologic surgery. Ketamine's beneficial effect on postoperative pain has not been investigated in patients undergoing robot thyroidectomy. The investigators hypothesized that perioperative ketamine administration can reduce acute postoperative pain after robot thyroidectomy and the incidence of chronic pain hypoesthesia on anterior chest at 3 months after surgery.
Interventions
Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).
DRUGNS infusion
Normal saline will be infused intraoperatively.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for robot-assisted thyroidectomy * ASA I-III
Exclusion criteria
* Patients with renal dysfunction * Patients with hepatic dysfunction * Patients with neurologic dysfunction * Patients with the history of drug addiction * Patients with chronic pain * Patients who are allergic to ketamine * Patients with increased ocular or intracranial pressure * Patients with the risk of aspiration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at 24 hour postoperatively | at 24 hour postoperatively | Pain at 24 hour postoperatively will be evaluates using 11 point scale (0:no pain, 10:worst imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at 3, 6, 12, 48 and 72 hour postoperatively | at 3, 6, 12, 48 and 72 hour postoperatively | Pain at 3, 6, 12, 48 and 72 hour postoperatively will be evaluated using 11-point scale 0:no pain, 10:worst imaginable) |
| Time to the first analgesics postoperatively | At 24 hours postoperatively | Time from the end of anesthesia till the first analgesic agent will be recorded at 24 hours postoperatively. |
| Analgesic requirements for 24 hours after surgery | at 24 hours postoperatively | Analgesic requirements for 24 hours after surgery will be evaluated. |
| Chronic pain at 3 month after surgery | At 3 month after surgery | Chronic pain at 3 month after surgery will be evaluated. |
Countries
South Korea
Contacts
Primary ContactHee-Pyoung Park, PhD
Backup ContactHyun-Chang Kim, MD
Outcome results
None listed