Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation

NCT00443404 | Completed Phase 2 DMC

• 2 other identifiers: phantom pain-UPatrasThere are no secondary Id
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

1

ACTIVE COMPARATOR

perioperative epidural analgesia

Procedure: perioperative epidural catheter

2

ACTIVE COMPARATOR

Iv PCA Fentanyl preoperative, Epidural analgesia postoperative

Procedure: perioperative epidural catheter

3

ACTIVE COMPARATOR

perioperative IV PCA Fentanyl, epidural anesthesia

Procedure: perioperative epidural catheter

4

ACTIVE COMPARATOR

perioperative IV PCA Fentanyl general anesthesia

Procedure: perioperative epidural catheter

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

Procedure: perioperative epidural catheter

Interventions

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)

1; 2; 3; 4; 5

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No written patient consent
• Age \< 18 years
• Age \> 82 years
• Antiplatelet medication
• Mental status not acceptable
• 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).

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Unknown Facility

Pátrai, Greece

Location

Related Publications (1)

• 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.

  PMID: 21368651 DERIVED

MeSH Terms

Conditions

Phantom Limb; Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 6, 2007
• Study Start: December 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2009
• Last Updated: November 7, 2011

Record last verified: 2009-09

Locations

GR (1)