A Comparison of Anaesthetic Methods for Total Knee Replacement Surgery

NCT02249481 | Terminated

• 1 other identifier: 14/P/132
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Replacement

Keywords

Anaesthetic; total knee replacement; Femoral nerve catheter; Adductor canal catheter

Outcome Measures

Primary Outcomes (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.

  24 hours post-op

• 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.

  48 hours post-op

Secondary Outcomes (5)

• Total opiate consumption

  48 hours post-op

• Visual Analogue Score (VAS) for pain

  24 and 48 hours post-op

• Range of knee flexion

  24 and 48 hours post-op

• Maximum Voluntary Isometric Contraction (MVIC)

  24 and 48 hours post-op

• Oxford Knee Score (OKS)

  Pre-op, and at 6 months post-op

Study Arms (2)

Group F

ACTIVE COMPARATOR

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

Group A

EXPERIMENTAL

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

Adductor Canal catheter delivering 0.0625% L- Bupivacaine PROCEDURE

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)

Group A

Femoral nerve catheter delivering 0.0625% L- Bupivacaine PROCEDURE

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)

Group F

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8BQ, United Kingdom

Location

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Matt Oldman, MB BS, FRCA

  University Hospital Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 25, 2014
• Study Start: December 8, 2015
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: September 6, 2019

Record last verified: 2019-08

Locations

GB (1)