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

NCT02374008 | Completed Phase 4 DMC

• 1 other identifier: 2014-003343-35
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Nerve Block; Pain

Keywords

Peripheral nerve block; Total knee Arthroplasty; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  0 - 20 hours postoperatively

Secondary Outcomes (12)

• Opioid consumption

  0 - 24 hours postoperatively

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

  At timepoint 2 , 6, 20 and 24 hours postoperatively

• Pain score at rest

  At timepoint 2 , 6, 20 and 24 hours postoperatively

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

  0-24 hours postoperatively

• Nausea Score

  At timepoint 2, 6, 20, 24 hours postoperatively

Study Arms (2)

Combined nerve block

EXPERIMENTAL

Ropivacaine and Adrenalin, systemic Ketorolac and high dose Dexamethasone

Drug: Ropivacaine

Local infiltrationanalgesia

ACTIVE COMPARATOR

Ropivacaine, Adrenalin and Ketorolac combined with systemic high dose dexamethasone

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Also known as: Adrenalin, Ketorolac, Dexamethasone

Combined nerve block; Local infiltrationanalgesia

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Regionshospitalet Silkeborg: lead

Related Publications (1)

• 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.

  PMID: 29346228 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine; Epinephrine; Ketorolac; Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Charlotte Runge, MD

  Regionalhospital Silkeborg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D student

Study Record Dates

• First Submitted: February 22, 2015
• First Posted: February 27, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 30, 2015

Record last verified: 2015-11