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This study compares analgesic efficacy, and safety of three different doses of peri-operative pregabaline to placebo following radical cystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (placebo) | Placebo Comparator | patients received placebo. |
|
| Group II (pregabaline 300 once) | Active Comparator | patients received pregabalin 300 mg 2 hours preoperatively. |
|
| Group III (pregabaline 300 twice) | Active Comparator | patients received pregabalin 300 mg 2 hours preoperatively and 12 hours after the preoperative dose. |
|
| Group IV (pregabaline 600) | Active Comparator | patients received pregabalin 600 mg 2 hours preoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabaline 300 mg once. | Drug | patients received pregabaline 300 mg 2 hours pre-operatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale (VAS) score | analgesic efficacy of study drugs as represented by the VAS score of the patients in the first 24 hours. | 24 hours postoperatively |
| postoperative opioid consumption | ability of study drugs to reduce the postoperative opioid analgesic consumption. | 24 hours postoperatively |
| time to first request of opioid analgesia | ability of the study drugs to delay the request of rescue opioid analgesia. | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by incidence of side effects | represented by the incidence of side effects during the follow up period of 24 hours. | 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| pregabaline 300 mg twice. | Drug | patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later. |
|
| pregabaline 600 mg once. | Drug | patients received pregabaline 600 mg 2 hours pre-operatively. |
|
| placebo | Drug | patients received placebo |
|