Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)

Healthpoint Hospital

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04834440

MF2467-2021-14

Details and patient eligibility

About

The aim of this study is to determine the minimal effective ropivacaine concentration required to provide adequate analgesic femoral nerve block in 90% of patients (MEAC90)

Full description

• Before induction of GA, all patients will receive sciatic, obturator, lateral femoral cutaneous and femoral nerve blocks.
• The femoral nerve block will be performed using 15ml of ropivacaine which concentration relied on the response of the previous patient.
• Based on biased-coin design up-down sequential method: when a patient has a negative response, the next patient will receive a concentration 0.01% w/v higher. However if he has a positive response, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less.
• Patients with pain free recovery will be considered to have positive response.
• Patients' responses will be analyzed to calculate the MEAC90

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients, who are scheduled for knee ligament reconstruction

Exclusion criteria

• <18 y,

• ASA physical class greater >III

  • BMI >40 has any contraindication for medications or techniques used in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)