Perioperative Analgesia for Knee Arthroplasty (PAKA)

University of Warwick

Status and phase: Completed; Phase 4

Conditions: Knee Arthritis

Treatments: Drug: peri-articular infiltration; Drug: Femoral Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT01560767

2010-020466-18 (EudraCT Number)

PAKA/PROTOCOL/V002

Details and patient eligibility

About

Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg and Ketorolac 30mg reduces postoperative pain following primary total knee replacement compared with the current standard treatment of femoral nerve blockade.

Enrollment: 46 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing an elective primary unilateral total knee arthroplasty (TKA) under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS trust are potentially eligible for the trial.

Exclusion criteria

• Those with sufficient cognitive impairment that they would be unable complete questionnaire (cognitive impairment).
• Those patients who lack capacity under the Mental Capacity Act 2005
• Those patients with a pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury.
• Those patients having spinal anaesthesia.
• Those patients with a specific contraindication to the analgesic agents used:Morphine: Hypersensitivity reaction Ketorolac: Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
• Haemorrhagic diatheses, including coagulation disorders
• Hypersensitivity to ketorolac trometamol or other NSAIDs
• Moderate or severe renal impairment (serum creatinine > 160 micromol/l)
• Levobupivicaine: Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients
• Uncontrolled angina
• 2nd/ 3rd degree heart block

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Femoral Nerve Block

Active Comparator group

Description:

levobupivacaine

Treatment:

Drug: Femoral Nerve Block

peri-articular infiltration

Active Comparator group

Description:

The peri-articular infiltration of multimodal agents will consist of 150 mg of levobupivacaine, 10 mg morphine and 30mg ketorolac diluted in 0.9% saline to make a volume 100 ml. (0.5ml 1:1000 adrenaline will be added to the mixture to reduce blood loss after the operation) Fifty ml of the mixture will be injected into the posterior, medial and lateral soft-tissues just prior to implantation of the TKA components. Care will be taken to avoid excessive infiltration in the area of the common peroneal nerve. Then, while the cement is curing, the anterior soft-tissues including the quadriceps mechanism, the retinacular tissues and the subcuticular tissues will be infiltrated with the remaining 50 ml of peri-articular injection.

Treatment:

Drug: peri-articular infiltration