Prospective, double-blind, randomised trial to assess the efficacy of continuous sciatic/posterior tibial nerve blockade via a neural sheath catheter in lower limb amputees - bupivacaine phantom pain

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000619-27-GB

Enrollment

Registered

2007-05-15

Start date

2007-08-13

Completion date

Unknown

Last updated

2020-05-25

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

Conditions

Stump and phantom limb pain after lower limb amputation MedDRA version: 9.1 Level: LLT Classification code 10056238 Term: Phantom pain MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain

Interventions

Trade Name: chirocaine 0.125% Product Name: chirocaine 1.25mg/ml Pharmaceutical Form: Solution for infusion INN or Proposed INN: levobupivacaine hydrochloride Concentration unit: mg/ml milligram(s)/mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients admitted to our vascular unit requiring a below or above knee amputation irrespective of aetiology. 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: 1. Patients not considered for surgical intervention. 2. Patients who are deemed unfit to undergo surgery under general anaesthesia. 3. Patients unable to operate a Patient-controlled analgesia device or cooperate with evaluation of pain scores e.g. those with confusional states. 4. Patients unwilling to consent 5. Allergy to any study medication

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish the effects of continuous peri- and post-operative sciatic/posterior tibial nerve blockade using a levobupivacaine infusion via a neural sheath catheter on late stump pain, phantom limb sensations and phantom limb pain.;Secondary Objective: To assess the effect of this technique on early postoperative pain and morphine requirements. To ascertain the late effects on mood, physical disability and quality of life ;Primary end point(s): 1. Stump pain scores, phantom pain scores and non-painful phantom sensation at 12 months after surgery 2. The presence or absence of allodynia at the stump site at 12 months after surgery	—

Measure

Time frame

Main Objective: To establish the effects of continuous peri- and post-operative sciatic/posterior tibial nerve blockade using a levobupivacaine infusion via a neural sheath catheter on late stump pain, phantom limb sensations and phantom limb pain.;Secondary Objective: To assess the effect of this technique on early postoperative pain and morphine requirements. To ascertain the late effects on mood, physical disability and quality of life ;Primary end point(s): 1. Stump pain scores, phantom pain scores and non-painful phantom sensation at 12 months after surgery 2. The presence or absence of allodynia at the stump site at 12 months after surgery

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 10, 2026