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OpenTrials
Completed

NCT Number: NCT00905580

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

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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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pregabalin

Drug

Pregabalin 150 mg orally

Vitamin Complex (placebo)

Drug

Vitamin Complex 150 mg orally

Primary outcomes

  1. Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.

    Time frame: 1, 6, 24 & 48 hours

    Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 means no pain at all, and 10 represents the worst pain imaginable

  2. The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.

    Time frame: 1, 6, 24 & 48 hours

    Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given. We asked patients about sedation, headache, dizziness, blurred vision.

  3. Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively

    Time frame: 1, 6, 24 & 48 hours

Secondary outcomes

  1. Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.

    Time frame: 3 months

    we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 20, 2009
Registry last updated
Jan 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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