Living Kidney Donors Undergoing VAMS-nephrectomy Clinical Trial
| NCT number | NCT02340455 |
| Other study ID # | 4-2014-0907 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2014 |
| Est. completion date | December 2016 |
| Verified date | February 2019 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mechanical threshold | 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 |