The Effect of Saphenous Nerve and Obturator Nerve Block Combined With Systemic High Dose Glucocorticoid Versus Local Infiltration Analgesia Combined With a Systemic High Dose Glucocorticoid on Opioid Consumption and Pain After Total Knee Arthroplasty
Overview
- Phase
- Phase 4
- Intervention
- Ropivacaine
- Conditions
- Peripheral Nerve Block
- Sponsor
- Regionshospitalet Silkeborg
- Enrollment
- 74
- Primary Endpoint
- Opioid consumption
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Purpose:
The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.
Background:
Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.
Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a well-known local anesthetic. Adrenaline have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined with high dose systemic Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.
Method
The patient can receive one of two treatments, determined randomly:
- A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine, Adrenaline) combined with systemic ketoroloc and high dose Dexamethasone and local infiltration around the knee joint with placebo medicine (normal saline).
- B. Both blocks with placebo medicine (normal saline) and local infiltration around the knee joint with activ local anesthetic.
Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.
The blocks will be placed before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
Investigators
Charlotte Runge
MD, Ph.D student
Regionshospitalet Silkeborg
Eligibility Criteria
Inclusion Criteria
- •Age\> 50 years
- •Patients set to cemented Total knee arthroplasty in spinal block
Exclusion Criteria
- •Patients who can not cooperate with the investigation
- •Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
- •Patients who do not understand or speak Danish
- •Patients receiving immunosuppressive therapy
- •Patients receiving glucocorticoid daily
- •Patients with a treatment-dependent diabetes mellitus
- •Patients with known neuropathy in the lower limbs
- •Allergy to those used in the study drugs
- •Alcohol and / or drug abuse - the investigator's opinion
- •Patients who can not tolerate NSAIDs
Arms & Interventions
Combined nerve block
Ropivacaine and Adrenalin, systemic Ketorolac and high dose Dexamethasone
Intervention: Ropivacaine
Local infiltrationanalgesia
Ropivacaine, Adrenalin and Ketorolac combined with systemic high dose dexamethasone
Intervention: Ropivacaine
Outcomes
Primary Outcomes
Opioid consumption
Time Frame: 0 - 20 hours postoperatively
Secondary Outcomes
- Pain Score by passive flexion of the knee joint from 0-90 degrees.(At timepoint 2 , 6, 20 and 24 hours postoperatively)
- Nausea Score(At timepoint 2, 6, 20, 24 hours postoperatively)
- Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu).(0-24 hours postoperatively)
- Preoperatively isometric tests of muscle strength in the hip adductors.(pre and 30 minutes after block placement)
- Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.(0-24 hours posteratively)
- Pain score at rest(At timepoint 2 , 6, 20 and 24 hours postoperatively)
- Discharge time from the hospital(maximum 60 hour postoperatively.)
- Opioid consumption(0 - 24 hours postoperatively)
- Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)(0-24 hours postoperatively)
- Number of vomiting(0- 20 hours and 0-24 hours postoperatively)
- Consumption of Ondansetron(0-20 hours and 0-24 hours)
- Reporting of dizziness Recording whether the dizziness is preventing mobilization.(at timepoint 2, 6, 20 and 24 hours postoperatively.)