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Completed

NCT Number: NCT02374008

The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty.

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.

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Key information

Conditions

Peripheral Nerve Block Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ropivacaine

Drug

Other names: Adrenalin, Ketorolac, Dexamethasone

Primary outcomes

  1. Opioid consumption

    Time frame: 0 - 20 hours postoperatively

Secondary outcomes

  1. Opioid consumption

    Time frame: 0 - 24 hours postoperatively

  2. Pain Score by passive flexion of the knee joint from 0-90 degrees.

    Time frame: At timepoint 2 , 6, 20 and 24 hours postoperatively

    Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.

  3. Pain score at rest

    Time frame: At timepoint 2 , 6, 20 and 24 hours postoperatively

    Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The highest score since last score recorded.

  4. Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)

    Time frame: 0-24 hours postoperatively

    Recorded at PCA(patient-controlled-analgesia) pump

  5. Nausea Score

    Time frame: At timepoint 2, 6, 20, 24 hours postoperatively

    NRS (numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea. The highest score since last score recorded.

  6. Number of vomiting

    Time frame: 0- 20 hours and 0-24 hours postoperatively

  7. Consumption of Ondansetron

    Time frame: 0-20 hours and 0-24 hours

  8. Reporting of dizziness Recording whether the dizziness is preventing mobilization.

    Time frame: at timepoint 2, 6, 20 and 24 hours postoperatively.

    Recording whether the dizziness is preventing

  9. Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu).

    Time frame: 0-24 hours postoperatively

    The end time for the LOS in PACU recorded at the time when the patient meets DASAIMs (Danish Society of Anaesthesiology and Intensive Therapy) printing criteria - regardless of Pacu 's logistics in general.

  10. Discharge time from the hospital

    Time frame: maximum 60 hour postoperatively.

  11. Preoperatively isometric tests of muscle strength in the hip adductors.

    Time frame: pre and 30 minutes after block placement

    Performed by a handheld dynamometer before and 30 minutes after performed nerve blockades. The patient performed 4-10 measurements with a 30 second break in between each measurement. The difference between the highest value for the test before and after nerve block is calculated.

  12. Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.

    Time frame: 0-24 hours posteratively

Sponsors and collaborators

Lead sponsor

Regionshospitalet Silkeborg

Other

Registry information

Official study 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

Acronym: HOBSALIplus

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2015
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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