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Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA) - Randomized, double-blind, controlled, multi-center trial comparing Optimized intravenous pain control vs Optimized intravenous pain control plus Regional anesthesia

Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA) - Randomized, double-blind, controlled, multi-center trial comparing Optimized intravenous pain control vs Optimized intravenous pain control plus Regional anesthesia - PLATA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41348
Enrollment
130
Registered
2013-07-19
Start date
2014-02-06
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pain Phantom limb pain

Interventions

Sciatic nerve block with continuous application of local anesthetic during surgery, and during the first week after surgery.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients undergoing elective transtibial amputation for peripheral vascular disease, age over 18 years, ASA* status II to IV. * ASA American Society of Anesthesiology classification.

Exclusion criteria

Exclusion criteria: - contraindication to peripheral regional anesthesia - confirmed allergy to local anesthetics - prior amputation resulting in current phantom limb pain - severe psychiatric disease - pregnancy or breastfeeding status - amputation for tumour surgery - traumatic amputation and - inability to give written and informed consent.

Design outcomes

Primary

MeasureTime frame
Point prevalence of chronic phantom limb pain after 12 months.

Secondary

MeasureTime frame
- Subjective classification of chronic phantom limb pain by patient in the preceding 4 weeks - SF-12v2 Short form 12 quality of life assessment - McGill short Pain Questionnaire - Vascular preoperative status - SIGAM mobility scale - Inventarization of rehabilitation methods applied during follow-up - Inventarization of drugs used to treat phantom limb pain - Incidence of reamputation and surgical complications (bleeding, infection of surgical site)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)