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

University of Patras

Status and phase: Completed; Phase 3; Phase 2

Conditions: Phantom Limb Pain

Treatments: Procedure: perioperative epidural catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00443404

phantom pain-UPatras

There are no secondary Id

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 82 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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60 participants in 5 patient groups, including a placebo group

1

Active Comparator group

Description:

perioperative epidural analgesia

Treatment:

Procedure: perioperative epidural catheter

2

Active Comparator group

Description:

Iv PCA Fentanyl preoperative, Epidural analgesia postoperative

Treatment:

Procedure: perioperative epidural catheter

3

Active Comparator group

Description:

perioperative IV PCA Fentanyl, epidural anesthesia

Treatment:

Procedure: perioperative epidural catheter

4

Active Comparator group

Description:

perioperative IV PCA Fentanyl general anesthesia

Treatment:

Procedure: perioperative epidural catheter

5

Placebo Comparator group

Description:

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

Treatment:

Procedure: perioperative epidural catheter