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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
46
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.
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.
University of Warwick, University House,
Coventry, United Kingdom
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.
Time frame: 18 Hours post operatively
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.
Time frame: First 48 hours post surgery
Analgesia required
The total use of "as required" analgesia in the first 48hrs after the operation
Time frame: 48 hour period post operativley
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).
Time frame: 6 hours post operation and pre and post retransfusion
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.
Time frame: 18 & 48 Hours and 6 weeks post surgery
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