Effect of Oral Pregabalin on Hyperalgesia and Post-operative Pain in Patients Undergoing Nephrectomy Surgery: Sex Differential Study

February 14, 2019 updated by: Yonsei University
Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA, an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting hyperalgesia. If the GABA level can be maintained at certain level, the progression into hyperalgesia can be averted. GABA related drugs are known to decrease the postoperative opioid consumption, lower the degree of pain, and prevent hyperalgesia. We hypothesize the effective postoperative pain management and the prevention of hyperalgesia from pregabalin, GABA analogue, and the possible sex difference in such effects of pregabalin.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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, 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

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18, <51 years

    • healthy patients accepted for video-assisted living donor nephrectomy

Exclusion Criteria:

  • Female patients who are pregnant or menopause
  • Patients undergoing hormonal therapy
  • Patients having neurologic disease or already taking GABA related drugs (pregabalin, gabapentin), or taking opioid drugs
  • Insulin resistant diabetes
  • Renal deficiency (eGFR < 60 ml/min/1.73 m2)
  • Emergency operation, hemodynamically unstable patients
  • Foreigner
  • allergic to medication given in this study

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
Experimental: Pregabalin_male
Drug: Pregabalin_male
Pregabalin 150mg bid 1day Men
Experimental: Pregabalin_female
Drug: Pregabalin_female
Pregabalin 150mg bid 1day Women
Active Comparator: Placebo_male
Drug: Placebo_Men
Placebo durg
Active Comparator: Placebo_female
Drug: Placebo_Women
Placebo_Women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical threshold
Time Frame: from 1 day before op to postop 48 hr
Mechanical threshold can be measured using von Frey filaments at both incision site and non-dominant arm
from 1 day before op to postop 48 hr

Collaborators and Investigators

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

Sponsor

Yonsei University

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

December 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0907

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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