The Influence of the Femoral Nerve Block on Quadriceps Strength

NCT01111513 | Completed

• 1 other identifier: PEJ-413
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacement is a frequent procedure in Québec's hospitals and the muscular strength of the quadriceps is the best indicator of the patient's functional recovery post surgery. Thus, the importance of the patient's recovery leads to the evaluation of the influence of the femoral nerve block on the muscle strength. The purpose of the study is to compare the short term and long term recuperation of the quadriceps' motor strength of after a total knee arthroplasty using different types of analgesics such as the continuous femoral nerve block, the single dose femoral nerve block and the systemic analgesic, a patient controlled analgesic pump.

Conditions

Total Knee Arthroplasty

Keywords

knee surgery; total knee arthroplasty; total knee replacement; ropivacaine; femoral nerve block

Outcome Measures

Primary Outcomes (3)

• Quadriceps strength measurement with Cybex machine

  Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.

  6 weeks after surgery

• Quadriceps strength measurement with Cybex machine

  Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.

  6 months after surgery

• Quadriceps strength measurements with Cybex machine

  Evidence of the influence of the different types of analgesics on the strength of the quadriceps post surgery. Quadriceps strength will be evaluated in open chain and closed chain with the help of the Cybex machine.

  12 months after surgery

Secondary Outcomes (5)

• Overall functional recovery

  6 weeks after surgery

• Pain score on Visual Analog Scale (VAS)

  every 6 hour for the 48 hours following surgery

• Hospital stay length

  4 to 7 days after surgery

• Overall functional recovery

  6 months after surgery

• Overall functional recovery

  12 months after surgery

Study Arms (3)

Continuous femoral block

ACTIVE COMPARATOR

Patients receive a continuous femoral block for 48 hours and they have patient controlled analgesics.

Drug: 48-hour ropivacaine infusions

Single dose femoral block

ACTIVE COMPARATOR

Patients receive a single dose femoral block and have patient controlled analgesics.

Drug: Single dose ropivacaine

Patient controlled analgesics

ACTIVE COMPARATOR

Patients do not receive a femoral block. They only have patient controlled analgesics.

Drug: Patient controlled analgesics

Interventions

48-hour ropivacaine infusions DRUG

Patients receive 20 ml of ropivacaine 0.5 % pre-operation through femoral block catheter, followed by ropivacaine infusions from 0.1 % to 0.1 ml/kg/hour for 48 hours.

Also known as: ropivacaine, femoral block

Continuous femoral block

Single dose ropivacaine DRUG

Patients receive 20 ml of ropivacaine 0.5% pre-operation

Also known as: ropivacaine

Single dose femoral block

Patient controlled analgesics DRUG

Patient controlled analgesics alone, no femoral block

Also known as: analgesics

Patient controlled analgesics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years old
• men or women needing an elective total knee replacement surgery

You may not qualify if:

• unicompartmental arthroplasty
• revision surgery for knee arthroplasty
• previous surgery on same knee
• previous fracture of femur/patella with functional after-effects
• allergies or contraindication to any medication used during study or to local anaesthesia technique
• preexisting neurological deficit
• severe anomaly of intracardiac conduction
• previous vascular surgery near the site of introduction of the catheter
• pregnancy or breastfeeding
• ASA IV or V14 class
• Men or women \> 18 years old unfit to consent
• \< 18 years old
• Refusal to sign consent form

Sponsors & Collaborators

• Hopital de l'Enfant-Jesus: lead
• Sanofi: collaborator

Study Sites (1)

CHA-Pavillon Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

MeSH Terms

Interventions

Ropivacaine; Analgesics

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Stéphane Pelet, MD, PhD

  Hôpital Enfant-Jésus

  PRINCIPAL INVESTIGATOR

• Michèle Angers, PhD

  Hôpital Enfant-Jésus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Stephane Pelet MD, PhD Orthopedic surgeon

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 27, 2010
• Study Start: November 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: February 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

CA (1)