Clinical trial NCT00443404: Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
Official title: Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Phantom Limb Pain
Keywords: phantom
amputation
analgesia
pain
preemptive
perioperative
lower limb amputation
intensity of phantom limb pain
preemptive analgesia reduces phantom pain
perioperative analgesia reduces phantom pain
Severe Phantom Limb Pain (VAS>70 mm)
resistant to medical treatment one week before amputation
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2007-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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 ketamine/clonidine 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 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.

Eligibility criteria: Inclusion Criteria:

* Age \>18, Visual Analog. Scale (VAS) pain score \>70mm which was frequent or continuous one week before scheduled major (above or below knee) amputation, and patient consent.

Exclusion Criteria:

* No written patient consent
* Age \< 18 years
* Age \> 82 years
* Antiplatelet medication
* Mental status not acceptable
* Exclusion criteria were age \>85
* Emergency amputation
* Ipsilateral re-amputation
* Foot or toe amputation
* Inability to complete a detailed pain questionnaire
* History of chronic pain or substance abuse
* Active psychiatric disease requiring treatment
* Any contraindication to epidural catheter placement (anticoagulation, anti-platelet medications, previous lumbar spine surgery).

Primary outcomes:
measure: 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.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Patras
country: Greece
Study officials:
affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
name: Diamanto N. Aretha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
name: Menelaos Karanikolas, MD, MPH
role: STUDY_DIRECTOR
affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
name: Kriton S Filos, MD Professor
role: STUDY_CHAIR
affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Anaesthesiology and Critical Care Medicine
name: Georgia Monantera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Patras, School of Medicine, University Hospital of Patras, Rion, 26500, Department of Surgery
name: Ioannis Tsolakis, MD Professor
role: STUDY_DIRECTOR
References:
citation: 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.