Protracted Effect of Combined Nerve Blocks After Total Knee Arthroplasty

NCT02067078 | Completed Phase 4 DMC

• 1 other identifier: 2013-005010-36
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Total Knee Arthroplasty; Pain; Nerve Blocks

Keywords

nerve block; total knee arthroplasty; saphenous nerve block; obturator nerve block; pain; opioid consumption

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  1 to 24 hours postoperatively

Secondary Outcomes (17)

• Opioid consumption

  1 to 48 hours postoperatively

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

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

• Pain Score at rest

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

• Patient-reported time to first postoperative breakthrough pain

  Time 1 - 48 hours postoperatively

• Nausea

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

Study Arms (3)

Combined saphenous nerve and obturator nerve block

EXPERIMENTAL

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

Saphenous nerve block

EXPERIMENTAL

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

Local infiltration analgesia

ACTIVE COMPARATOR

Drug: Ropivacaine + Toradol + Adrenaline

Interventions

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

Combined saphenous nerve and obturator nerve block

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

Saphenous nerve block

Ropivacaine + Toradol + Adrenaline DRUG

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

Local infiltration analgesia

Eligibility Criteria

• Age: 50 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Regionshospitalet Silkeborg: lead

Study Sites (1)

Regional hospital Silkeborg

Silkeborg, Region Midt, 8600, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

Dexamethasone; Bupivacaine; Ropivacaine; Ketorolac Tromethamine; Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

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

Study Record Dates

• First Submitted: February 16, 2014
• First Posted: February 20, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

DK (1)