Phase 4 N=99 Randomized Triple-blind Treatment

Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT00905580 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2010

Primary outcome: Primary: Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. — 6; 6; 3; 2 VNRS

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pregabalin (Drug); Vitamin Complex (placebo) (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Severance Hospital
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.	6; 6; 3; 2; 2; 1	—
PRIMARY The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.	10; 7; 11; 8; 6; 14	—
PRIMARY Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively	31; 26; 17; 7; 15; 2	—
SECONDARY Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.	13; 10	—

Summary

The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months after operation.

Eligibility Criteria

Inclusion Criteria

American Society of Anesthesia physical status class I & II
Age ≥ 20 and ≤ 65 years
Robot- assisted endoscopic thyroidectomy

Exclusion Criteria

Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
Body mass index ≥ 40 kg/m2
History of seizure disorder
Current therapy with pregabalin, gabapentin, or any opioid
Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
Insulin-dependent diabetes mellitus
Renal insufficiency (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2)

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Data sourced from ClinicalTrials.gov (NCT00905580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.