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

NCT ID: NCT02340455

Last Updated: 2019-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Living Kidney Donors Undergoing VAMS-nephrectomy

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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Pregabalin_male

Group Type EXPERIMENTAL

Pregabalin_male

Intervention Type DRUG

Pregabalin 150mg bid 1day Men

Pregabalin_female

Group Type EXPERIMENTAL

Pregabalin_female

Intervention Type DRUG

Pregabalin 150mg bid 1day Women

Placebo_male

Group Type ACTIVE_COMPARATOR

Placebo_Men

Intervention Type DRUG

Placebo durg

Placebo_female

Group Type ACTIVE_COMPARATOR

Placebo_Women

Intervention Type DRUG

Placebo\_Women

Interventions

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Pregabalin_male

Pregabalin 150mg bid 1day Men

Intervention Type DRUG

Pregabalin_female

Pregabalin 150mg bid 1day Women

Intervention Type DRUG

Placebo_Men

Placebo durg

Intervention Type DRUG

Placebo_Women

Placebo\_Women

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0907

Identifier Type: -

Identifier Source: org_study_id

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