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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later

Group Type PLACEBO_COMPARATOR

Vitamin Complex (placebo)

Intervention Type DRUG

Vitamin Complex 150 mg orally

Pregabalin

Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

Pregabalin 150 mg orally

Interventions

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Pregabalin

Pregabalin 150 mg orally

Intervention Type DRUG

Vitamin Complex (placebo)

Vitamin Complex 150 mg orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No