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Motor-Sparing Femoral Nerve Block Dose

U

University of Chile

Status and phase

Terminated
Phase 4

Conditions

Knee Injuries
Osteoarthritis, Knee

Treatments

Drug: Lower Bupivacaine Concentration
Drug: Same Bupivacaine Concentration

Study type

Interventional

Funder types

Other

Identifiers

NCT02909257
OAIC 823/16

Details and patient eligibility

About

Femoral nerve blocks are commonly used to provide pain control for total knee replacement, anterior cruciate ligament (ACL) reconstruction. Commonly employed local anesthetic concentrations result in motor block of the quadriceps and constitute an inherent risk factor for patient fall.

The aim of this study is to determine the minimum effective concentration of bupivacaine in 90 % of patients (MEC90) required for a motor-sparing, successful sensory block of the femoral nerve.

Full description

With the approval of Ethics Committee of the University of Chile Clinical Hospital, approximately 60 patients undergoing ACL repair or TKR will be recruited. All blocks will be conducted preoperatively in an induction room.Dose assignation will be done using an up-and-down sequential method, where the dose of each subsequent patient depends on the response of the previous patient, called the Biased Coin Design.

The assignment of each subsequent concentration will be based on the response of the previous patient.As soon as we recruit 45 patients with random dose assignment, we will terminate the enrollment procedure.

The injectate will be prepared and administered by a research assistant using syringes connected to the block needle. The operator and the patient will be blinded to the concentration injected.

Enrollment

31 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 18 and 75 years
  • American Society of Anesthesiologists classification 1-3
  • Body mass index between 20 and 35

Exclusion criteria

  • Adults who are unable to give their own consent
  • Pre-existing neuropathy (assessed by history and physical examination)
  • Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
  • Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
  • Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
  • Allergy to LA
  • Pregnancy
  • Prior surgery in the inguinal region
  • Chronic pain syndromes requiring opioid intake at home

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

31 participants in 2 patient groups

same dose
Experimental group
Description:
patient is exposed to the same previously successful dose
Treatment:
Drug: Same Bupivacaine Concentration
lower dose
Experimental group
Description:
patient is exposed to a lower concentration dose
Treatment:
Drug: Lower Bupivacaine Concentration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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