Motor-Sparing Femoral Nerve Block Dose

Osteoarthritis, Knee Clinical Trial

Official title:

Minimum Effective Concentration of Bupivacaine for Motor-Sparing Femoral Nerve Block

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02909257
• Other study ID #: OAIC 823/16
• Status: Terminated
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2020
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries
• Osteoarthritis, Knee

Intervention

Drug:
• Same Bupivacaine Concentration
patient is exposed to the same concentration than previously successful one
• Lower Bupivacaine Concentration
patient is exposed to a lower concentration than previously successful one

Locations

Country	Name	City	State
Chile	Hospital Clinico Universidad de Chile	Santiago	Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (10)

Biboulet P, Morau D, Aubas P, Bringuier-Branchereau S, Capdevila X. Postoperative analgesia after total-hip arthroplasty: Comparison of intravenous patient-controlled analgesia with morphine and single injection of femoral nerve or psoas compartment block — View 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. — View 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 Ju — View Citation

Jæger P, Koscielniak-Nielsen ZJ, Hilsted KL, Fabritius ML, Dahl JB. Adductor Canal Block With 10 mL Versus 30 mL Local Anesthetics and Quadriceps Strength: A Paired, Blinded, Randomized Study in Healthy Volunteers. Reg Anesth Pain Med. 2015 Sep-Oct;40(5): — View Citation

Johnson RL, Kopp SL, Hebl JR, Erwin PJ, Mantilla CB. Falls and major orthopaedic surgery with peripheral nerve blockade: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):518-28. doi: 10.1093/bja/aet013. Epub 2013 Feb 24. Review. — View 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. — View 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. — View Citation

Schiferer A, Gore C, Gorove L, Lang T, Steinlechner B, Zimpfer M, Kober A. A randomized controlled trial of femoral nerve blockade administered preclinically for pain relief in femoral trauma. Anesth Analg. 2007 Dec;105(6):1852-4, table of contents. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum Bupivacaine Analgesic concentration preserving quadriceps strength analgesia		5 months