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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02340455
Enrollment
0
Registered
2015-01-16
Start date
2014-12-31
Completion date
2016-12-31
Last updated
2019-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Living Kidney Donors Undergoing VAMS-nephrectomy

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.

Interventions

DRUGPregabalin_male

Pregabalin 150mg bid 1day Men

DRUGPregabalin_female

Pregabalin 150mg bid 1day Women

DRUGPlacebo_Men

Placebo durg

DRUGPlacebo_Women

Placebo\_Women

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mechanical thresholdfrom 1 day before op to postop 48 hrMechanical threshold can be measured using von Frey filaments at both incision site and non-dominant arm

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026