The aim of this study is to test the hypothesis that a combination of optimized intravenous pain therapy and continuous sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Point prevalence of chronic phantom limb pain after 12 months.
Secondary outcome
- 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)
Background summary
Phantom limb pain following amputation is a major clinical problem. Current
evidence how to best prevent phantom limb pain is equivocal because previous
trials have included small numbers of patients, and tested heterogeneous
patient collectives. There is some evidence that optimized perioperative pain
control is effective in preventing phantom limb pain, but the potential added
role of regional anesthesia has not been defined.
Study objective
The aim of this study is to test the hypothesis that a combination of optimized
intravenous pain therapy and continuous sciatic nerve block decreases the point
prevalence of phantom limb pain 12 months after transtibial amputation for
peripheral vascular disease when compared to optimized intravenous pain therapy
alone.
Study design
Interventional, randomized, prospective, triple-blind (patient, physician,
statistician) clinical trial.
Intervention
Sciatic nerve block with continuous application of local anesthetic during
surgery, and during the first week after surgery.
Study burden and risks
All patients, regardless of group allocation, will receive optimized
intravenous pain treatment. The aim of this study is to assess whether
additional regional anesthesia (ultrasound-guided sciatic nerve block) can
further decrease the incidence of phantom limb pain.
The administration of both optimized intravenous pain treatment and peripheral
nerve blockade is routine clinical practice for many procedures on the lower
leg, including amputation. The risk of this intervention can be described as
very low.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-000875-33-NL |
| ClinicalTrials.gov | NCT01626755 |
| CCMO | NL43843.018.13 |