Perioperative Analgesia for Knee Arthroplasty (PAKA) (PAKA)

Can Periarticular Knee Injection of Multimodal Agents Levobupivicaine, Morphine, Ketorolac and Adrenaline Improve Postoperative Pain and Function Following Primary Total Knee Arthroplasty?

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthritis
• Intervention / Treatment: Drug: Femoral Nerve Block; Drug: peri-articular infiltration

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Coventry, United Kingdom, CV4 8UW
    • University of Warwick, University House,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Femoral Nerve Block; levobupivacaine	Drug: Femoral Nerve Block; Under aseptic conditions, the femoral artery will be palpated immediately below the inguinal ligament and nerve stimulation will be used to identify the femoral nerve just lateral to the artery. Once the femoral nerve has been identified the block may be performed in the routine manner, using 30 ml of levobupivacaine 0.25%. The precise technique used will be noted on trial documentation.
Active Comparator: peri-articular infiltration; 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.	Drug: peri-articular infiltration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	A validated, patient-reported 100 mm visual analogue pain score. It is a line 100mm long on which patient places a line through to mark the severity of the pain the patient is experiencing from 0mm= No pain to 100mm wost pain possible.	18 Hours post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4 point pain score	An ordinal 4-point pain score recorded every six hours by an independent nurse during the first 48 hrs after the surgery.	First 48 hours post surgery
Analgesia required	The total use of "as required" analgesia in the first 48hrs after the operation	48 hour period post operativley
Concentration of Levobupivicaine in drain and patient serum samples	The concentration of local anaesthetic agent (Levobupivicaine) in the drain fluid collected in the Bellovac ABT and patient serum concentrations. The drain concentration will be assessed at 6 hrs post operation with serum concentrations pre-retransfusion (tourniquet- down time + 40 mins) and post-retransfusion (post-op + 6hrs 40min).	6 hours post operation and pre and post retransfusion
Functional Assessments change over time 18, 48 & 6 weeks	The patients 'straight-leg raise' and mobilisation will be assessed by an independent physiotherapist on the ward after the surgery and a more formal functional assessment of the knee will be made at 6 weeks using the Oxford Knee Score: a validated, patient-reported measure of knee function.	18 & 48 Hours and 6 weeks post surgery

Collaborators and Investigators

• Sponsor: University of Warwick
• Investigators: Principal Investigator: Matthew Costa, University of Warwick

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: August 16, 2011
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): March 22, 2012
• Last Update Submitted That Met QC Criteria: March 20, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Arthroplasty; Pain relief; periarticular knee infiltration
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: PAKA/PROTOCOL/V002; 2010-020466-18 (EudraCT Number)