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

January 15, 2010 updated by: Severance Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later
Drug: Vitamin Complex (placebo)
Vitamin Complex 150 mg orally
Experimental: Pregabalin
Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later
Drug: Pregabalin
Pregabalin 150 mg orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 6, 24 & 48 hours
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.
1, 6, 24 & 48 hours
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
Time Frame: 1, 6, 24 & 48 hours
1, 6, 24 & 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 15, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 4-2009-0070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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