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

Completed

Conditions: Chronic pain
10034606
Phantom limb pain

Registration Number: NL-OMON41348

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Point prevalence of chronic phantom limb pain after 12 months. </p><br>

Secondary Outcome Measures

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