A Comparison of Anaesthetic Methods for Total Knee Replacement Surgery

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02249481
• Other study ID #: 14/P/132
• Status: Terminated
• Phase: N/A
• Start date: December 8, 2015
• Est. completion date: June 27, 2017

Study information

• Verified date: August 2019
• Source: University Hospital Plymouth NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Plymouth NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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