Clinical trial NCT02909257: Motor-Sparing Femoral Nerve Block Dose
Official title: Minimum Effective Concentration of Bupivacaine for Motor-Sparing Femoral Nerve Block
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Knee Injuries
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Minimum Bupivacaine Analgesic concentration preserving quadriceps strength analgesia
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
state: Metropolitan
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: DE QH TRAN, MD, FRCPC
role: STUDY_DIRECTOR
References:
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citation: Dauri M, Sidiropoulou T, Fabbi E, Giannelli M, Faria S, Mariani P, Sabato AF. Efficacy of continuous femoral nerve block with stimulating catheters versus nonstimulating catheters for anterior cruciate ligament reconstruction. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):282-7. doi: 10.1016/j.rapm.2006.06.249.
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citation: Casati A, Fanelli G, Beccaria P, Magistris L, Albertin A, Torri G. The effects of single or multiple injections on the volume of 0.5% ropivacaine required for femoral nerve blockade. Anesth Analg. 2001 Jul;93(1):183-6. doi: 10.1097/00000539-200107000-00036.
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citation: Lu YM, Lin JH, Hsiao SF, Liu MF, Chen SM, Lue YJ. The relative and absolute reliability of leg muscle strength testing by a handheld dynamometer. J Strength Cond Res. 2011 Apr;25(4):1065-71. doi: 10.1519/JSC.0b013e3181d650a6.
citation: Lu TW, Hsu HC, Chang LY, Chen HL. Enhancing the examiner's resisting force improves the reliability of manual muscle strength measurements: comparison of a new device with hand-held dynamometry. J Rehabil Med. 2007 Nov;39(9):679-84. doi: 10.2340/16501977-0107.
citation: Tran DQ, Dugani S, Dyachenko A, Correa JA, Finlayson RJ. Minimum effective volume of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):190-4. doi: 10.1097/AAP.0b013e31820d4266.
citation: Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 Mar;58(1):171-7. doi: 10.1111/j.0006-341x.2002.00171.x.