Clinical trial NCT02374008: The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Nerve Block
Pain
Keywords: Peripheral nerve block
Total knee Arthroplasty
Dexamethasone
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 74
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age\> 50 years
* Patients set to cemented Total knee arthroplasty in spinal block
* ASA 1-3

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
* Fixed several times daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl)

Primary outcomes:
measure: Opioid consumption
timeFrame: 0 - 20 hours postoperatively
Secondary outcomes:
measure: Opioid consumption
timeFrame: 0 - 24 hours postoperatively
measure: Pain Score by passive flexion of the knee joint from 0-90 degrees.
timeFrame: At timepoint 2 , 6, 20 and 24 hours postoperatively
measure: Pain score at rest
timeFrame: At timepoint 2 , 6, 20 and 24 hours postoperatively
measure: Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)
timeFrame: 0-24 hours postoperatively
measure: Nausea Score
timeFrame: At timepoint 2, 6, 20, 24 hours postoperatively
measure: Number of vomiting
timeFrame: 0- 20 hours and 0-24 hours postoperatively
measure: Consumption of Ondansetron
timeFrame: 0-20 hours and 0-24 hours
measure: Reporting of dizziness Recording whether the dizziness is preventing mobilization.
timeFrame: at timepoint 2, 6, 20 and 24 hours postoperatively.
measure: Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu).
timeFrame: 0-24 hours postoperatively
measure: Discharge time from the hospital
timeFrame: maximum 60 hour postoperatively.
measure: Preoperatively isometric tests of muscle strength in the hip adductors.
timeFrame: pre and 30 minutes after block placement
measure: Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.
timeFrame: 0-24 hours posteratively
Other outcomes:
Locations:
Study officials:
affiliation: Regionalhospital Silkeborg
name: Charlotte Runge, MD
role: STUDY_DIRECTOR
References:
citation: Runge C, Jensen JM, Clemmesen L, Knudsen HB, Holm C, Borglum J, Bendtsen TF. Analgesia of Combined Femoral Triangle and Obturator Nerve Blockade Is Superior to Local Infiltration Analgesia After Total Knee Arthroplasty With High-Dose Intravenous Dexamethasone. Reg Anesth Pain Med. 2018 May;43(4):352-356. doi: 10.1097/AAP.0000000000000731.