Effect of Adductor Canal Nerve Block Compared to a Simulated Block on Quadriceps Strength Following Knee Arthroplasty

Effect of Adductor Canal Femoral Nerve Block Compared to a Simulated Block on Knee Extensor Muscle Strength Following Total Knee Arthroplasty

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.

Study Overview

Detailed Description

On arrival in the operating room, patients will be randomly assigned to receive an adductor canal block under ultrasound guidance or a simulated block.

In the adductor canal block group, a 18 Gauge Tuohy needle will be inserted and its position in the adductor canal adjacent to the femoral artery 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.

In the simulated block group, 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.

Surgery will be performed under spinal anesthesia. A standardized dose of bupivacaine and morphine will be administered for spinal anesthesia.

In both groups, an infusion of local anesthetics will be initiated on arrival in the recovery room and will continue for the first 48 hours. To preserve the blinding in the simulated block group, a Luer-lock connector and a 50 mL empty pouch of intravenous fluids will be affixed to the catheter to collect the infused local anesthetics. The empty pouch will be inserted under the opaque dressing. Patients in the adductor canal block will receive an infusion of bupivacaine 0.125% at 12 mL/h and patients in the simulated block group will have an infusion of the same medication but at an infusion rate of 1 mL/h. The infusion rate will be hidden from the patient. Multimodal analgesia will be used in all patients.

Patients will be asked to complete the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire before and 6 weeks following surgery.

Knee extensor muscle strength will be measured using a hand-held dynamometer pre-operatively and 24 hours, 48 hours and 6 weeks following surgery. Pain scores at rest and during strength assessment will be collected. Opioids consumption and side-effects attributable to analgesia will be recorded. Patients will be asked to rate their global satisfaction regarding the quality of analgesia 48 hours after surgery. Time to discharge will be recorded.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adductor canal femoral nerve blockade
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.
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.
Placebo Comparator: Simulated nerve blockade
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee extensor muscle strength
Time Frame: 6 weeks after surgery
Will be measured using a hand-held dynamometer
6 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee extensor muscle strength
Time Frame: 24 hours and 48 hours following surgery
Will be measured using a hand-held dynamometer
24 hours and 48 hours following surgery
Intensity of pain at rest
Time Frame: Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery
Will be assessed using a Visual Analog Scale (VAS) from 0 to 10: 0 being no pain at all and 10 being the worst pain imaginable
Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery
Intensity of pain during extensor muscle strength assessment
Time Frame: Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery
Will be assessed using a Visual Analog Scale (VAS) from 0 to 10: 0 being no pain at all and 10 being the worst pain imaginable
Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery
Opioid consumption
Time Frame: 24 and 48 hours following surgery
24 and 48 hours following surgery
Side-effects attributable to analgesia
Time Frame: 24 and 48 hours following surgery
The presence of nausea and emesis will be recorded
24 and 48 hours following surgery
Global satisfaction regarding analgesia
Time Frame: 48 hours following surgery
Will be assessed using a scale from 1 to 10: 1 being totally dissatisfied and 10 being totally satisfied
48 hours following surgery
Physical function in daily life
Time Frame: Immediately prior to surgery and 6 weeks following surgery
Will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Immediately prior to surgery and 6 weeks following surgery
Time to discharge from hospital
Time Frame: Patients will be followed for the duration of hospital stay, an average of 4 days
Patients will be followed for the duration of hospital stay, an average of 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 14.093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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