Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443404
Status:
COMPLETED
Last Update Posted:
2011-11-06
First Post:
2007-03-05
Brief Title:
Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
Sponsor:
University of Patras
Organization:
University of Patras
Study Overview
Official Title:
Double Blind Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe pre-amputation pain is associated with phantom pain development and phantom pain models assign major importance to central and peripheral nervous system changes related to pre-amputation pain Several interventions have been evaluated for phantom pain prevention including continuous brachial plexus blockade5 intravenous6 or epidural ketamine administration postoperative perineural ketamineclonidine infusion8 and oral gabapentin9 but their true effect remains unclear
Detailed Description:
In a prospective randomized double-blind trial 65 patients undergoing elective lower limb amputation were assigned to one of five analgesic regimens Patients in groups 1-4 had lumbar epidural catheter placed 48 hours before amputation and received epidural bupivacainefentanyl or saline infusion before andor after amputation Patients receiving epidural saline also had IV Fentanyl Patient-Control Analgesia whereas patients receiving epidural analgesia also had IV saline Group 5 control received IM meperidine and oral codeineacetaminophen VAS and McGill Pain Questionnaire MPQ scores for ischemic phantom and stump pain were recorded starting 48 hours before continuing until 48 hours after amputation and at 4 days 10 days 1 and 6 months after amputation Phantom and stump pain intensity and frequency were the main study endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| There are no secondary Id | None | None | None |