Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Postoperative Pain (Ampupain)

Universidad de Antioquia

Status and phase: Not yet enrolling; Phase 3

Conditions: Pain, Chronic; Phantom Limb Pain

Treatments: Drug: Continuous sciatic nerve block; Drug: Epidural catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05608733

IN-47-2021

Details and patient eligibility

About

Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants

Full description

Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants Outcomes: Primary: Numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) was used for pain assessments daily for 15 days and subsequently monthly until completing 3 months. Co-primary: Assessment of symptomatology related to phantom limb pain daily for 15 days POP and subsequently monthly until completing 3 months.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age over 18 years
2. Being scheduled for above or below knee amputation or for bone remodeling of lower limb amputees
3. Acceptance of continuous regional analgesic technique as part of their multimodal analgesia

Exclusion criteria

1. Traumatic cause of amputation
2. Allergy to local anesthetics
3. Contraindication for epidural technique or continuous blocks
4. Stage 5 kidney disease
5. Concomitant use of aspirin and clopidogrel
6. Pregnancy status

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups

Epidural catheter

Experimental group

Description:

Epidural catheter infusion of bupivacaine 0.1% (4-6 cc/h) at level L3-L4

Treatment:

Drug: Epidural catheter

Continuous sciatic nerve block

Active Comparator group

Description:

Continuous sciatic catheter infusion of bupivacaine 0.1% (6-10 cc/h)

Treatment:

Drug: Continuous sciatic nerve block