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Completed

NCT Number: NCT02067078

Protracted Effect of Combined Nerve Blocks 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 surgery with knee replacement. In the combined nerve blocks we use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone ("protracted mixture") and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain and reduces the need for morphine 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. Bupivacaine is a well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone 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 Bupivacaine, Adrenaline, Clonidine and 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 three treatments, determined randomly:

* A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline, Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine (normal saline). * B. Saphenous block with active anesthetics and both Obturator nerve block and local block around the knee joint with placebo medicine (normal saline). * C. Both block with placebo medicine (normal saline) and local block around the knee joint with effective local anesthetic.

Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.

The blocks will be injected 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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regional hospital Silkeborg

Silkeborg, Region Midt, 8600, Denmark

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
  • Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
  • Illness score 1-3

Exclusion criteria

  • Patients who can not cooperate with the investigation
  • Patients who do not understand or speak Danish
  • Patients receiving immunosuppressive therapy
  • Patients with a treatment-dependent diabetes mellitus
  • Patients with known neuropathy in the lower limbs
  • Allergy to those drugs used in the study
  • Alcohol and / or drug abuse - the investigator's opinion
  • Patients who can not tolerate Non steroid analgesic drugs
  • Use of strong opioid several times a day (morphine, ketogan, Oxynorm, methadone, fentanyl)

Treatment and study plan

Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram

Drug

Dexamethasone 4 mg Clonidine 75 microgram Marcaine 90 mg Adrenaline 90 microgram

Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram

Drug

Dexamethasone 2 mg Clonidine 37,5 microgram Marcaine 45 mg Adrenaline 45 microgram

Ropivacaine + Toradol + Adrenaline

Drug

Ropivacaine 300 mg + Toradol 45 mg + Adrenaline 0,75 mg

Primary outcomes

  1. Opioid consumption

    Time frame: 1 to 24 hours postoperatively

Secondary outcomes

  1. Opioid consumption

    Time frame: 1 to 48 hours postoperatively

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

    Time frame: Time 1, 2, 5, 7, 24, 31, 48 hours postoperatively

    numeric rating scale with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable

  3. Pain Score at rest

    Time frame: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively

    Numeric rating scale with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable

  4. Patient-reported time to first postoperative breakthrough pain

    Time frame: Time 1 - 48 hours postoperatively

  5. Nausea

    Time frame: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively .

    numeric rating scale with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea

  6. Vomiting

    Time frame: Number of between 24 hours postoperatively

  7. Ondansetron

    Time frame: Consumption at time 24 hours postoperative

  8. Number of nights with patient-reported sleep disruptions

    Time frame: Time 48 hours postoperatively

  9. Duration of stay in the post anesthesia care unit

    Time frame: 1 - 48 hours postoperatively

  10. Discharge time from the hospital

    Time frame: Time 1 hour to 2 weeks postoperatively

  11. Patient-reported consumption of opioid

    Time frame: From the discharge date from hospital to ambulatory monitoring 2 weeks postoperatively

  12. Quantitative satisfaction of pain

    Time frame: At 2 weeks postoperatively

    By indicating satisfaction score (0-10 ) , where the value 0 = complete dissatisfaction and 10 = complete satisfaction.

  13. Isometric tests of muscle strength in the hip adductors

    Time frame: 1-2 hours preoperatively and again 30 minutes after the application of obturator nerve blockade

    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 blockade construction calculated.

  14. Time at mobilization to walk with or without support in the form of a walker, crutches or caregivers.

    Time frame: Time 1 to 48 hours postoperatively

  15. Timed Up and Go test

    Time frame: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively

    The patient rise from a chair and walk round 3 metres and sit on the chair again . The time for completion of the test are recorded .

  16. Cumulated Ambulation Score to illustrate the basic level of mobilization

    Time frame: 1-2 hours pre-operatively, during the first postoperative mobilization, and time 24 hours postoperatively

    The patient scores based on 3 gradations according to their ability to mobilize up and in bed, getting up from a chair and walk with or without aids in the form of high walker or crutches

  17. Movement of the knee joint

    Time frame: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively

    The patient ability to extend and flex in the knee joint are recorded. The tests are performed with a goniometer

Sponsors and collaborators

Lead sponsor

Regionshospitalet Silkeborg

Other

Registry information

Official study title

The Effect of Protracted Saphenous Nerve and Obturator Nerve Block Versus Saphenous Nerve Block Versus Local Infiltration Analgesia on Opioid Consumption, Pain, Block Duration of Action and Mobilization After Total Knee Arthroplasty.

Acronym: Hobsali

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2014
Registry last updated
Feb 4, 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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