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Motor-Sparing Femoral Nerve Block Dose

Primary Purpose

Osteoarthritis, Knee, Knee Injuries

Status

Terminated

Phase

Phase 4

Locations

Chile

Study Type

Interventional

Intervention

Same Bupivacaine Concentration

Lower Bupivacaine Concentration

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Clinico Universidad de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

same dose

lower dose

Arm Description

patient is exposed to the same previously successful dose

patient is exposed to a lower concentration dose

Outcomes

Primary Outcome Measures

Minimum Bupivacaine Analgesic concentration preserving quadriceps strength analgesia

Secondary Outcome Measures

Full Information

NCT ID

NCT02909257

First Posted

September 19, 2016

Last Updated

May 13, 2020

Sponsor

University of Chile

1. Study Identification

Unique Protocol Identification Number

NCT02909257

Brief Title

Motor-Sparing Femoral Nerve Block Dose

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Terminated

Why Stopped

inadequate methodology to determine primary outcome

Study Start Date

September 2016 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Chile

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Knee Injuries

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

same dose

Arm Type

Experimental

Arm Description

patient is exposed to the same previously successful dose

Arm Title

lower dose

Arm Type

Experimental

Arm Description

patient is exposed to a lower concentration dose

Intervention Type

Drug

Intervention Name(s)

Same Bupivacaine Concentration

Intervention Description

patient is exposed to the same concentration than previously successful one

Intervention Type

Drug

Intervention Name(s)

Lower Bupivacaine Concentration

Intervention Description

patient is exposed to a lower concentration than previously successful one

Primary Outcome Measure Information:

Title

Minimum Bupivacaine Analgesic concentration preserving quadriceps strength analgesia

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

DE QH TRAN, MD, FRCPC

Organizational Affiliation

McGill University Health Centre/Research Institute of the McGill University Health Centre

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Clinico Universidad de Chile

City

Santiago

State/Province

Metropolitan

ZIP/Postal Code

8380456

Country

Chile

12. IPD Sharing Statement

Citations:

PubMed Identifier

15029544

Citation

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. a prospective, randomized, double-blind study. Reg Anesth Pain Med. 2004 Mar-Apr;29(2):102-9. doi: 10.1016/j.rapm.2003.11.006.

Results Reference

result

PubMed Identifier

17720111

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.

Results Reference

result

PubMed Identifier

18042893

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. doi: 10.1213/01.ane.0000287676.39323.9e.

Results Reference

result

PubMed Identifier

23440367

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.

Results Reference

result

PubMed Identifier

11429362

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.

Results Reference

result

PubMed Identifier

26237001

Citation

Jaeger 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):553-8. doi: 10.1097/AAP.0000000000000298.

Results Reference

result

PubMed Identifier

20838248

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.

Results Reference

result

PubMed Identifier

17999004

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.

Results Reference

result

PubMed Identifier

21270721

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.

Results Reference

result

PubMed Identifier

11890313

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.

Results Reference

result

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Motor-Sparing Femoral Nerve Block Dose

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