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

Yonsei University

Status: Withdrawn

Conditions: Living Kidney Donors Undergoing VAMS-nephrectomy

Treatments: Drug: Placebo_Women; Drug: Pregabalin_female; Drug: Pregabalin_male; Drug: Placebo_Men

Study type: Interventional

Funder types: Other

Identifiers

NCT02340455

4-2014-0907

Details and patient eligibility

About

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.

Sex: All

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 4 patient groups

Pregabalin_male

Experimental group

Treatment:

Drug: Pregabalin_male

Pregabalin_female

Experimental group

Treatment:

Drug: Pregabalin_female

Placebo_male

Active Comparator group

Treatment:

Drug: Placebo_Men

Placebo_female

Active Comparator group

Treatment:

Drug: Placebo_Women