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TerminatedNCT02249481Updated Sep 6, 2019

A Comparison of Anaesthetic Methods for Total Knee Replacement Surgery

An interventional study of Adductor Canal catheter delivering 0.0625% L- Bupivacaine and Femoral nerve catheter delivering 0.0625% L- Bupivacaine in Total Knee Replacement, sponsored by University Hospital Plymouth NHS Trust. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-09-06.

Sponsored by University Hospital Plymouth NHS Trust · Not applicable, Interventional, and Treatment

Why this study was terminated
A number of issues which impact on the ability to recruit patients to the study
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Total Knee Replacement

Keywords

  • Anaesthetic
  • total knee replacement
  • Femoral nerve catheter
  • Adductor canal catheter
03

In context

Lead sponsor

University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureAdductor 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.

    Also known as: Adductor Canal Block (0.0625% L- Bupivacaine)

  • ProcedureFemoral 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.

    Also known as: Femoral nerve Block (0.0625% L- Bupivacaine)

06

What researchers measure

Primary outcomes

  1. Timed Up Go (TUG) test

    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.

    Time frame: 24 hours post-op

  2. Timed Up Go (TUG) test

    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.

    Time frame: 48 hours post-op

Secondary outcomes

  1. Total opiate consumption

    morphine equivalence

    Time frame: 48 hours post-op

  2. Visual Analogue Score (VAS) for pain

    Both at rest and on active movement

    Time frame: 24 and 48 hours post-op

  3. Range of knee flexion

    The range of flexion movement (in degrees) is recorded using a goniometer

    Time frame: 24 and 48 hours post-op

  4. Maximum Voluntary Isometric Contraction (MVIC)

    The quadriceps muscle power in the operative leg is assessed using a handheld dynamometer (HHD)

    Time frame: 24 and 48 hours post-op

  5. Oxford Knee Score (OKS)

    Patient reported outcome score.

    Time frame: Pre-op, and at 6 months post-op

07

Study locations

1 site
  • Plymouth Hospitals NHS Trust
    Plymouth, Devon PL6 8BQ, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02249481
Lead sponsor
University Hospital Plymouth NHS Trust
Responsible party
Sponsor
First posted
Sep 25, 2014
Start date
Dec 8, 2015
Primary completion
Jun 27, 2017
Completion
Jun 27, 2017
Last update
Sep 6, 2019

Study contacts

Matt Oldman, MB BS, FRCA
principal investigator · University Hospital Plymouth NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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