Back to resultsPerioperative Analgesia for Knee Arthroplasty (PAKA) (PAKA)
Primary Purpose
Knee Arthritis
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Femoral Nerve Block
peri-articular infiltration
Sponsored by
About this trial
This is an interventional supportive care trial for Knee Arthritis focused on measuring Pain relief, Arthroplasty, periarticular knee infiltration
Eligibility 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
Sites / Locations
- University of Warwick, University House,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Femoral Nerve Block
peri-articular infiltration
Arm Description
levobupivacaine
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Analgesia required
The total use of "as required" analgesia in the first 48hrs after the operation
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01560767
Brief Title
Perioperative Analgesia for Knee Arthroplasty (PAKA)
Acronym
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?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Warwick
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis
Keywords
Pain relief, Arthroplasty, periarticular knee infiltration
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Femoral Nerve Block
Arm Type
Active Comparator
Arm Description
levobupivacaine
Arm Title
peri-articular infiltration
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Femoral Nerve Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
peri-articular infiltration
Intervention 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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
18 Hours post operatively
Secondary Outcome Measure Information:
Title
4 point pain score
Description
An ordinal 4-point pain score recorded every six hours by an independent nurse during the first 48 hrs after the surgery.
Time Frame
First 48 hours post surgery
Title
Analgesia required
Description
The total use of "as required" analgesia in the first 48hrs after the operation
Time Frame
48 hour period post operativley
Title
Concentration of Levobupivicaine in drain and patient serum samples
Description
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).
Time Frame
6 hours post operation and pre and post retransfusion
Title
Functional Assessments change over time 18, 48 & 6 weeks
Description
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.
Time Frame
18 & 48 Hours and 6 weeks post surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Costa
Organizational Affiliation
University of Warwick
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Warwick, University House,
City
Coventry
ZIP/Postal Code
CV4 8UW
Country
United Kingdom
12. IPD Sharing Statement
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Perioperative Analgesia for Knee Arthroplasty (PAKA)
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