A Trial of Lidocaine Patch for Lower Limb Amputation Pain

Phase 2

Withdrawn

• Conditions: Primary/Secondary Scar Hyperalgesia; Phantom Limb Pain (PLP)
• Interventions: Other: Sham; Drug: Lidocaine

• Registration Number: NCT02696720
• Lead Sponsor: Brugmann University Hospital

Brief Summary

Phantom limb pain (PLP) and scar hyperalgesia (SH) are frequent problems after amputation; in particular most persons who undergo limb amputation will experience phantom pain. The neuropathic nature of PLP suggests the involvement of both peripheral and central neurological mechanisms, including neuroplastic changes in the central nervous system. PLP as other central nervous system-related pain syndromes remains a challenge for treatment. Scar hyperalgesia involves peripheral mechanisms and results frim the production of substances liberated by damaged skin cells. These inflammatory substances lower the pain threshold by altering the chemical environment of skin nerve endings. Scan hyperalgesia is associated with secondary mechanical hyperalgesia in the skin area around the scar.

The lidocaine patch 5% is a topical analgesic acting by blocking sodium channels of peripheral nerve endings and by inhibiting ectopic discharges in sensitized and hyperactive cutaneous nociceptors. The patch is noninvasive, with minimal systemic absorption resulting in a reduced risk of drug-drug interaction. In addition, a central analgesic effect of lidocaine has been suggested. The lidocaine patch 5% is currently licensed for the treatment of symptomatic postherpetic neuralgia. It also has been successfully used in patients with other neuropathic pain states, such as entrapment neuropathies, painful idiopathic distal sensory polyneuropathies and postoperative/post traumatic neuropathic chronic cutaneous pain. The lidocaine patch has not been studied for the management and prevention of phantom limb pain.

The aim of the present research is to investigate if a lidocaine patch 5% is effective for reducing PLP and primary/secondary scar hyperalgesia. The hypothesis is that persistent peripheral nociceptive input from the stump after surgery may drive maladaptive cortical reorganization leading to chronic central pain and thus promote chronic phantom limb pain. Treating scar hyperalgesia on the stump with topical lidocaine may reduce the activity of peripheral nociceptive afferents and thus decrease the likelihood of developing persistent phantom limb pain.

This study is designed as a randomized controlled multicentric double blind trial, in which the effectiveness of applying a 5% lidocaine patch for 6 weeks will be compared with a sham.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-02
• Study Start: 2016-05-13
• Primary Completion: 2017-06-13
• Study Completion: 2017-06-13
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All above or below knee amputations , two months or more after surgery, after complete wound healing (no clips, no stitches, no seepage)

Exclusion Criteria

• History of central nervous system disease
• History of major psychiatric disease (MMS<23/30, HADS>8/21)
• Pregnancy
• Known hypersensitivity to local anesthetics (lidocaine, bupivacaine, etidocaine, mepivacaine, prilocaine)
• skin irritation on the stump

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham	During a period of six weeks, a visually identical patch (sham) will be applied around the wound (cut in two parts, 1cm above and below the wound, without direct contact with the scar) for a total of twelve hours per day, during night time.
Lidocaine	Lidocaine	During a period of six weeks, a lidocaine patch will be applied around the wound (cut in two parts, 1cm above and below the wound, without direct contact with the scar) for a total of twelve hours per day, during night time.

Primary Outcome Measures

Name	Time	Method
Patient-reported overall daily pain intensity	Daily, starting seven days before patch placement (baseline) till six weeks after patch placement	The overall daily pain intensity (stump, scar and phantom pain combined) will be rated on a 0 to 100 visual analogue scale with anchors of 0 (no pain) to 100 (worst pain ever experienced).

Secondary Outcome Measures

Name	Time	Method
Phantom Limb Pain occurence	6 months after patch placement	occurence of phantom limb pain
Neuropathic Pain (DN4)	at baseline - 7 days before patch placement	Screening for neuropathic pain, by using the DN4 questionnaire
Neuropathic pain	6 months after patch placement	Rated with the Neuropathic Pain Symptom Inventory
Quality of life	six months after patch placement	Will be rated by the SF36 questionnaire
Sleep quality	6 months after patch placement	will be assessed with the Pittsburgh Sleep Quality index
Cumulative analgesic consumption (morphine equivalents)	6 weeks after patch placement	Rated by the cumulative analgesic consumption score (CACS)
Pain (McGill)	6 weeks after patch placement	Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.
Delay of dress of provisory prosthesis	From the day of patient inclusion in the research protocol till the day of the delivery of temporary prosthesis, for a maximum of 6 months	Number of days between inclusion in the research protocol and delivery of temporary prosthesis

Trial Locations

Locations (2)

CHU Brugmann - Queen Astrid; 🇧🇪 Brussels, Belgium

Erasme -CTR; 🇧🇪 Brussels, Belgium