A Comparison of Anaesthetic Methods for Total Knee Replacement Surgery

September 3, 2019 updated by: University Hospital Plymouth NHS Trust

A Comparison of Continuous Adductor Canal Catheter Infusion vs Continuous Femoral Nerve Catheter Infusion for Total Knee Replacement Surgery

Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24 and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic team).

Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior patient mobilisation within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.

Secondary Objective: To identify whether adductor canal nerve infusions result in superior analgesia within the first 48 hours following total knee replacement compared to femoral nerve catheter infusions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

We are comparing a continuous adductor canal block with a low concentration continuous femoral nerve block. We currently use a low dose femoral nerve catheter based technique as part of our standard treatment strategy for total knee arthroplasty. The use of a catheter provides prolonged analgesia compared to a single shot block, and also allows a lower concentration of local anaesthetic to be employed, thus potentially reducing the incidence of motor blockade. The concentration of local anaesthetic employed in our routine practice (0.0625% L- Bupivacaine) is lower than that routinely used in many other centres, and most clinical studies have compared higher concentrations of local anaesthetic - this might be expected to produce more motor blockade. The concentration we use is higher than the minimum effective concentration for a femoral catheter infusion for knee arthroplasty.

Study Type

Interventional

Enrollment (Actual)

6

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

  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8BQ
        • Plymouth Hospitals Nhs Trust

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has a diagnosis of rheumatoid or osteoarthritis and listed for a primary total knee replacement.
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged between 18 and 85 years.
  • American Society of Anesthesiologists (ASA) score I-III
  • Able (in the clinical staff's opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be noti-fied of participation in the study.

Exclusion Criteria:

  • Patient refusal
  • Chronic pain (defined as consumption of >480mg codeine/24hrs or ANY regular strong opiate consumption by the oral/transdermal route)
  • Patients aged <18 or >85
  • ASA score >III
  • Body mass index (BMI) >35
  • Lacking mental capacity to give consent to enter trial/undergo surgery
  • Contraindications to catheter placement (coagulopathy , systemic sepsis or infection at placement site, pre-existing neuropathy) or any other component to the study treatment pathway.
  • Participant who is terminally ill
  • Allergy/intolerance to study medications
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group F
Femoral nerve catheter delivering 0.0625% L- Bupivacaine: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
Procedure: Femoral nerve catheter delivering 0.0625% L- Bupivacaine
Femoral nerve catheter: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
Other Names:
  • Femoral nerve Block (0.0625% L- Bupivacaine)
EXPERIMENTAL: Group A
Adductor canal catheter delivering 0.0625% L- Bupivacaine: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
Procedure: Adductor Canal catheter delivering 0.0625% L- Bupivacaine
Adductor canal catheter: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
Other Names:
  • Adductor Canal Block (0.0625% L- Bupivacaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up Go (TUG) test
Time Frame: 24 hours post-op
This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.
24 hours post-op
Timed Up Go (TUG) test
Time Frame: 48 hours post-op
This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.
48 hours post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opiate consumption
Time Frame: 48 hours post-op
morphine equivalence
48 hours post-op
Visual Analogue Score (VAS) for pain
Time Frame: 24 and 48 hours post-op
Both at rest and on active movement
24 and 48 hours post-op
Range of knee flexion
Time Frame: 24 and 48 hours post-op
The range of flexion movement (in degrees) is recorded using a goniometer
24 and 48 hours post-op
Maximum Voluntary Isometric Contraction (MVIC)
Time Frame: 24 and 48 hours post-op
The quadriceps muscle power in the operative leg is assessed using a handheld dynamometer (HHD)
24 and 48 hours post-op
Oxford Knee Score (OKS)
Time Frame: Pre-op, and at 6 months post-op
Patient reported outcome score.
Pre-op, and at 6 months post-op

Collaborators and Investigators

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

Sponsor

University Hospital Plymouth NHS Trust

Investigators

  • Principal Investigator: Matt Oldman, MB BS, FRCA, University Hospital Plymouth NHS Trust

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 (ACTUAL)

December 8, 2015

Primary Completion (ACTUAL)

June 27, 2017

Study Completion (ACTUAL)

June 27, 2017

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (ESTIMATE)

September 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/P/132

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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