A randomised, placebo controlled trial of levobupivacaine or the combination of levobupivacaine and clonidine when administered as a sciatic perineural infusion for the prevention of phantom limb pain and cardiac morbidity after lower limb amputation - Incidence of phantom limb pain after lower limb amputation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005667-26-GB

Enrollment

300

Registered

2007-04-17

Start date

2007-07-11

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Pain after amputation MedDRA version: 8.1 Level: LLT Classification code 10004227 Term: Below knee amputation MedDRA version: 9.1 Level: LLT Classification code 10000243 Term: Above knee amputation

Interventions

Trade Name: Levobupivacaine Pharmaceutical Form: Injection* INN or Proposed INN: CLONIDINE HYDROCHLORIDE CAS Number: 4205918 Current Spo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients presenting for elective lower limb amputation will be approached for recruitement to this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients excluded from the study will be those with signs of cardiac failure (3rd heart sound, lung crepitations), hypovolaemia, respiratory failure, presence of seizures, dementia, or encephalopathy, and patients with any terminal illness with a life expectancy < 3 months

Design outcomes

Primary

Measure	Time frame
Main Objective: To measure the incidence of phantom limb pain 12 months after amputation; Secondary Objective: To measure: Incidence of phantom pain at 3 and 6 months Incidence of phantom sensation at 3, 6 and 12 months To measure functional and psychological end points at 3,6 and12 months ;Primary end point(s): The objective of the proposed study is to investigate the incidence of phantom limb pain and cardiac outcomes of patients after lower limb amputation when given a 7 day sciatic perineural infusion of saline, levobupivacaine 1.25 mg/ml or the combination of levobupivacaine 1.25 mg/ml and clonidine 1 mcg/ml.	—

Measure

Time frame

Main Objective: To measure the incidence of phantom limb pain 12 months after amputation; Secondary Objective: To measure: Incidence of phantom pain at 3 and 6 months Incidence of phantom sensation at 3, 6 and 12 months To measure functional and psychological end points at 3,6 and12 months ;Primary end point(s): The objective of the proposed study is to investigate the incidence of phantom limb pain and cardiac outcomes of patients after lower limb amputation when given a 7 day sciatic perineural infusion of saline, levobupivacaine 1.25 mg/ml or the combination of levobupivacaine 1.25 mg/ml and clonidine 1 mcg/ml.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026