Perioperative Analgesia for Knee Arthroplasty (PAKA)

Knee Arthritis Clinical Trial

— PAKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560767
• Other study ID #: PAKA/PROTOCOL/V002
• Secondary ID: 2010-020466-18
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2011
• Last updated: March 20, 2012
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2012
• Source: University of Warwick
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Knee Arthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Warwick, University House,	Coventry

Sponsors (1)

Lead Sponsor	Collaborator
University of Warwick

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Analgesia required	The total use of "as required" analgesia in the first 48hrs after the operation	48 hour period post operativley	No
Secondary	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	No
Secondary	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	No