Perioperative Administration of Pregabalin for Pain After Mastectomy

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Pregabalin; Drug: Vitamin Complex (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT00938548

IRB 4-2009-0186

Details and patient eligibility

About

The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy 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 VNRS at 1 week and 1 month after operation.

Enrollment: 70 patients

Sex: Female

Ages: 21 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. American Society of Anesthesia physical status class I & II
2. Age > 20 and < 70 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Vitamin Complex (placebo)

Pregabalin

Experimental group

Description:

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

Treatment:

Drug: Pregabalin