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

Not Applicable

Withdrawn

• Conditions: Living Kidney Donors Undergoing VAMS-nephrectomy
• Interventions: Drug: Pregabalin_male; Drug: Pregabalin_female; Drug: Placebo_Men; Drug: Placebo_Women

• Registration Number: NCT02340455
• Lead Sponsor: Yonsei University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-16
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 18, <51 years

  • healthy patients accepted for video-assisted living donor nephrectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin_male	Pregabalin_male	-
Pregabalin_female	Pregabalin_female	-
Placebo_male	Placebo_Men	-
Placebo_female	Placebo_Women	-

Primary Outcome Measures

Name	Time	Method
Mechanical threshold	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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of