Perioperative Analgesia for Knee Arthroplasty (PAKA)

NCT01560767 | Completed Phase 4

• 2 other identifiers: PAKA/PROTOCOL/V0022010-020466-18
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthritis

Keywords

Pain relief; Arthroplasty; periarticular knee infiltration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 4 point pain score

  First 48 hours post surgery

• Analgesia required

  48 hour period post operativley

• Concentration of Levobupivicaine in drain and patient serum samples

  6 hours post operation and pre and post retransfusion

• Functional Assessments change over time 18, 48 & 6 weeks

  18 & 48 Hours and 6 weeks post surgery

Study Arms (2)

Femoral Nerve Block

ACTIVE COMPARATOR

levobupivacaine

Drug: Femoral Nerve Block

peri-articular infiltration

ACTIVE COMPARATOR

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

Interventions

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.

Femoral Nerve Block

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.

peri-articular infiltration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• nd/ 3rd degree heart block

Sponsors & Collaborators

• University of Warwick: lead

Study Sites (1)

University of Warwick, University House,

Coventry, CV4 8UW, United Kingdom

Location

Study Officials

• Matthew Costa

  University of Warwick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Trauma and Orthopaedic Surgery

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: March 22, 2012
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

GB (1)