Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.

J P Lecoq

Status and phase: Completed; Phase 4

Conditions: Postoperative Complications; Postoperative Pain

Treatments: Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode); Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)

Study type: Interventional

Funder types: Other

Identifiers

NCT03696095

2018-000822-70

Details and patient eligibility

About

This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.

Full description

This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• admitted for unilateral primary total knee arthroplasty.

Exclusion criteria

• ASA score > 3
• BMI > 40
• refusal of loco-regional technique.
• psychiatric disease.
• inability to understand/ use the Local anesthetic delivery pump.
• local anesthetic allergy,
• porphyry,
• uncontrolled epilepsy,
• severe cardiac arrhythmia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Continous infusion ropivacaine

Active Comparator group

Description:

Continuous infusion via peri-neural femoral nerve catheter of Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) at rate of 6ml/h + patient controlled bolus of 3ml ...

Treatment:

Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)

PIB ropivacaine

Experimental group

Description:

Programmed intermittent bolus of Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) : 6ml each 60min + patient controlled bolus 3ml ...

Treatment:

Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)