NCT02166710

Brief Summary

Total knee arthroplasty (TKA) is a frequent and effective surgery for knee osteoarthritis. This major surgery is associated with a reduction in knee extensor muscle strength persisting several weeks after surgery. This decrease in strength correlates with poor functional recovery. Its cause is multifactorial, including a deficit of the quadriceps activation, an acute postoperative atrophy of the muscle and an important limitation related to postoperative pain. Peripheral nerve blocks using local anesthetics are frequently used for postoperative analgesia following TKA. Femoral nerve blockade reduces pain and opioid consumption and allows early passive mobilization after surgery. This block also facilitates functional recovery and allows early discharge from the hospital. However, blocks involving the proximal femoral nerve contribute to quadriceps weakness for the duration of nerve blockade. Quadriceps weakness, in turn, results in functional impairment and increases recovery time. A possible long-term quadriceps weakness associated with the femoral nerve block has even been suggested in a recently published abstract. Hence, there is a need for an alternative technique that could minimize postoperative pain as well as the femoral nerve block without causing weakness of the quadriceps muscle. Femoral nerve block performed at the level of the adductor canal seems to be a promising alternative to the classic inguinal approach of the femoral nerve block. Studies comparing femoral nerve block performed at the canal adductor level to the inguinal approach reported a similar quality of analgesia, a reduction in motor block and a better functional recovery in the early postoperative period in the canal adductor block group. The long-term effect of femoral nerve block performed at the level of the adductor canal on knee extensor strength after surgery remains to be studied. This study will assess knee extensor muscle strength (principally quadriceps muscle) at 24h, 48h and 6 weeks following TKA in patients having a femoral nerve block at the adductor canal level compared to a simulated block. Hypothesis: The adductor canal block will allow superior recovery of knee extensor muscle strength when compared to a simulated block at 6 weeks after total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

June 5, 2014

Last Update Submit

January 30, 2017

Conditions

Keywords

Knee arthroplastyAdductor canal blockQuadriceps strength

Outcome Measures

Primary Outcomes (1)

  • Knee extensor muscle strength

    Will be measured using a hand-held dynamometer

    6 weeks after surgery

Secondary Outcomes (8)

  • Knee extensor muscle strength

    24 hours and 48 hours following surgery

  • Intensity of pain at rest

    Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery

  • Intensity of pain during extensor muscle strength assessment

    Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery

  • Opioid consumption

    24 and 48 hours following surgery

  • Side-effects attributable to analgesia

    24 and 48 hours following surgery

  • +3 more secondary outcomes

Study Arms (2)

Adductor canal femoral nerve blockade

EXPERIMENTAL

Patients will receive continuous adductor canal femoral nerve blockade for 48 hours with a catheter connected to a pump infusing bupivacaine 0.125% and multi-modal analgesia for pain management following total knee arthroplasty. Knee extensor muscle strength will be measured at different time-points prior and after surgery.

Device: Adductor canal femoral nerve block

Simulated nerve blockade

PLACEBO COMPARATOR

Patients will receive a simulated continuous femoral nerve block at the level of the adductor canal for 48 hours with a catheter connected to a pump infusing bupivacaine 0.125% and multi-modal analgesia for pain management following total knee arthroplasty. Knee extensor muscle strength will be measured at different time-points prior and after surgery.

Device: Simulated nerve blockade

Interventions

A 18 Gauge Tuohy needle will be inserted and its position will be confirmed using ultrasound guidance. Once the adequacy of the position is confirmed, the anesthesiologist will administer 15 mL of bupivacaine 0.25% with epinephrine in divided doses and examine the quality of its spread. A 20 Gauge polyamide catheter will be inserted at 2 cm in the space. The needle will then be withdrawn and the catheter will be fixed in place. Three mL of the same mixture of local anesthetics will be administered through the catheter and the anesthesiologist will observe the quality of its distribution. Bupivacaine 0.125% will be administered through the catheter using an infusion pump for 48 hours. Knee extensor muscle strength, pain and side-effects will be assessed at different time-points.

Adductor canal femoral nerve blockade

The insertion of the Tuohy needle and the injection of 15 mL of bupivacaine 0.25% with epinephrine will be simulated. The insertion of the polyamide catheter, the withdrawal of the needle and the injection of local anesthetics through the catheter will also be simulated. The infusion of bupivacaine 0.125% will also be simulated for 48 hours. Knee extensor muscle strength, pain and side-effects will be assessed at different time-points.

Simulated nerve blockade

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective unilateral total knee arthroplasty
  • Ability to complete the KOOS questionnaire
  • American Society of Anesthesiologists (ASA) class 1-3

You may not qualify if:

  • Contraindication to the adductor canal block (local infection, allergy to local anesthetics)
  • Surgery to be performed under general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

  • Williams SR. In Response. Anesth Analg. 2018 Sep;127(3):e50-e51. doi: 10.1213/ANE.0000000000003571. No abstract available.

Study Officials

  • François Girard, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 18, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations