Perioperative Analgesia for Knee Arthroplasty (PAKA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthew Costa, University of Warwick
ClinicalTrials.gov Identifier:
NCT01560767
First received: August 16, 2011
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Knee Arthritis
Drug: Femoral Nerve Block
Drug: peri-articular infiltration
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Can Periarticular Knee Injection of Multimodal Agents Levobupivicaine, Morphine, Ketorolac and Adrenaline Improve Postoperative Pain and Function Following Primary Total Knee Arthroplasty?

Resource links provided by NLM:


Further study details as provided by University of Warwick:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: 18 Hours post operatively ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 4 point pain score [ Time Frame: First 48 hours post surgery ] [ Designated as safety issue: No ]
    An ordinal 4-point pain score recorded every six hours by an independent nurse during the first 48 hrs after the surgery.

  • Analgesia required [ Time Frame: 48 hour period post operativley ] [ Designated as safety issue: No ]
    The total use of "as required" analgesia in the first 48hrs after the operation

  • Concentration of Levobupivicaine in drain and patient serum samples [ Time Frame: 6 hours post operation and pre and post retransfusion ] [ Designated as safety issue: No ]
    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).

  • Functional Assessments change over time 18, 48 & 6 weeks [ Time Frame: 18 & 48 Hours and 6 weeks post surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 46
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560767

Locations
United Kingdom
University of Warwick, University House,
Coventry, United Kingdom, CV4 8UW
Sponsors and Collaborators
University of Warwick
Investigators
Principal Investigator: Matthew Costa University of Warwick
  More Information

No publications provided

Responsible Party: Matthew Costa, Professor of Trauma and Orthopaedic Surgery, University of Warwick
ClinicalTrials.gov Identifier: NCT01560767     History of Changes
Other Study ID Numbers: PAKA/PROTOCOL/V002, 2010-020466-18
Study First Received: August 16, 2011
Last Updated: March 20, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Warwick:
Pain relief
Arthroplasty
periarticular knee infiltration

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Epinephrine
Ketorolac
Levobupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 24, 2014