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| There are no secondary Id |
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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 ketamine/clonidine infusion8 and oral gabapentin9, but their true effect remains unclear.
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 bupivacaine/fentanyl or saline infusion before and/or 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 codeine/acetaminophen. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | perioperative epidural analgesia |
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| 2 | Active Comparator | Iv PCA Fentanyl preoperative, Epidural analgesia postoperative |
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| 3 | Active Comparator | perioperative IV PCA Fentanyl, epidural anesthesia |
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| 4 | Active Comparator | perioperative IV PCA Fentanyl general anesthesia |
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| 5 | Placebo Comparator | IV PCA with saline 0.9% and sc saline 0.9%in the L3-L4 area. IM meperidine, po codeine/acetaminophen, IV acetaminophen and IV parecoxib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perioperative epidural catheter | Procedure | Perioperative epidural catheter in groups 1-4. Pre- and postoperative epidural analgesia in group 1. Preoperative IV PCA Fentanyl and postoperative epidural analgesia in group 2. Perioperative IV PCA Fentanyl in groups 2,3. IM meperidine p.o. codeine/acetaminophen, IV acetaminophen and IV parecoxib in group 5 (control) |
| Measure | Description | Time Frame |
|---|---|---|
| VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diamanto N. Aretha, MD | University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine | Principal Investigator |
| Menelaos Karanikolas, MD, MPH | University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine | Study Director |
| Kriton S Filos, MD Professor | University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine | Study Chair |
| Georgia Monantera, MD | University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine | Principal Investigator |
| Ioannis Tsolakis, MD Professor | University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pátrai | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21368651 | Derived | Karanikolas M, Aretha D, Tsolakis I, Monantera G, Kiekkas P, Papadoulas S, Swarm RA, Filos KS. Optimized perioperative analgesia reduces chronic phantom limb pain intensity, prevalence, and frequency: a prospective, randomized, clinical trial. Anesthesiology. 2011 May;114(5):1144-54. doi: 10.1097/ALN.0b013e31820fc7d2. |
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |