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

Pain Clinical Trial

— HOBSALIplus  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374008
• Other study ID #: 2014-003343-35
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2015
• Last updated: November 25, 2015
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Regionshospitalet Silkeborg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 100 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Peripheral Nerve Block

Intervention

Drug:
• Ropivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regionshospitalet Silkeborg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption		0 - 20 hours postoperatively	Yes
Secondary	Opioid consumption		0 - 24 hours postoperatively	Yes
Secondary	Pain Score by passive flexion of the knee joint from 0-90 degrees.	Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.	At timepoint 2 , 6, 20 and 24 hours postoperatively	Yes
Secondary	Pain score at rest	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.	At timepoint 2 , 6, 20 and 24 hours postoperatively	Yes
Secondary	Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)	Recorded at PCA(patient-controlled-analgesia) pump	0-24 hours postoperatively	Yes
Secondary	Nausea Score	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.	At timepoint 2, 6, 20, 24 hours postoperatively	Yes
Secondary	Number of vomiting		0- 20 hours and 0-24 hours postoperatively	Yes
Secondary	Consumption of Ondansetron		0-20 hours and 0-24 hours	Yes
Secondary	Reporting of dizziness Recording whether the dizziness is preventing mobilization.	Recording whether the dizziness is preventing	at timepoint 2, 6, 20 and 24 hours postoperatively.	Yes
Secondary	Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu).	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.	0-24 hours postoperatively	Yes
Secondary	Discharge time from the hospital		maximum 60 hour postoperatively.	Yes
Secondary	Preoperatively isometric tests of muscle strength in the hip adductors.	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.	pre and 30 minutes after block placement	Yes
Secondary	Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.		0-24 hours posteratively	Yes