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Completed

NCT Number: NCT01560767

Perioperative Analgesia for Knee Arthroplasty (PAKA)

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.

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Key information

Conditions

Knee Arthritis

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Warwick, University House,

Coventry, CV4 8UW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral Nerve Block

Drug

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

Drug

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.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 18 Hours post operatively

    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.

Secondary outcomes

  1. 4 point pain score

    Time frame: First 48 hours post surgery

    An ordinal 4-point pain score recorded every six hours by an independent nurse during the first 48 hrs after the surgery.

  2. Analgesia required

    Time frame: 48 hour period post operativley

    The total use of "as required" analgesia in the first 48hrs after the operation

  3. Concentration of Levobupivicaine in drain and patient serum samples

    Time frame: 6 hours post operation and pre and post retransfusion

    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).

  4. Functional Assessments change over time 18, 48 & 6 weeks

    Time frame: 18 & 48 Hours and 6 weeks post surgery

    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.

Sponsors and collaborators

Lead sponsor

University of Warwick

Other

Registry information

Official study title

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

Acronym: PAKA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 22, 2012
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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