Clinical trial · Interventional
Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain
Effects of Postoperative Percutaneous Peripheral Nerve Stimulation on Acute and Chronic Amputation Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
| Amputation | — | UNRESOLVED | — |
| Chronic Pain | — | UNRESOLVED | — |
| Neuroma | — | UNRESOLVED | — |
| Phantom Limb Pain | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
| Residual Limbs | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral nerve stimulation | Device | — | UNRESOLVED |
| Standard Medical Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Standard medical therapy and 30 to 60 days of peripheral nerve stimulation starting within 7 days after surgery
- interventionNames
- Device: Peripheral nerve stimulation
- Other: Standard Medical Therapy
- type
- ACTIVE_COMPARATOR
- label
- Group 2
- description
- Standard medical therapy only
- interventionNames
- Other: Standard Medical Therapy
Primary outcomes (6)
- measure
- Average Phantom Limb Pain (PLP) Score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Nontraumatic transfemoral (above-the-knee) or transtibial (below-the-knee) amputation * Presence of postamputation pain rated at least 4 or more Exclusion Criteria: * Beck Depression Inventory score greater than 20 * Systemic infection * Immunocompromised or taking immunosuppressive medications * Implanted electronic device * Pregnancy * Previous allergy to skin contact materials and/or anesthetic agent * Altered mental status * Inability to provide informed consent
References
Publications (31)
- BACKGROUNDHanley MA, Jensen MP, Smith DG, Ehde DM, Edwards WT, Robinson LR. Preamputation pain and acute pain predict chronic pain after lower extremity amputation. J Pain. 2007 Feb;8(2):102-9. doi: 10.1016/j.jpain.2006.06.004. Epub 2006 Sep 1. PMID 16949876
- BACKGROUNDKaranikolas 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
- BACKGROUNDKent ML, Hsia HJ, Van de Ven TJ, Buchheit TE. Perioperative Pain Management Strategies for Amputation: A Topical Review. Pain Med. 2017 Mar 1;18(3):504-519. doi: 10.1093/pm/pnw110. PMID 27402960
- BACKGROUNDCapdevila X, Bringuier S, Borgeat A. Infectious risk of continuous peripheral nerve blocks. Anesthesiology. 2009 Jan;110(1):182-8. doi: 10.1097/ALN.0b013e318190bd5b. No abstract available. PMID 19104185
- BACKGROUNDApfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E. PMID 12873949
- BACKGROUNDIlfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1. PMID 20889937
- BACKGROUNDIlfeld BM, Grant SA. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation for Postoperative Analgesia: Could Neurostimulation Replace Continuous Peripheral Nerve Blocks? Reg Anesth Pain Med. 2016 Nov/Dec;41(6):720-722. doi: 10.1097/AAP.0000000000000481. No abstract available.