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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Peripheral Nerve Block
• Intervention / Treatment: Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined nerve block; Ropivacaine and Adrenalin, systemic Ketorolac and high dose Dexamethasone	Drug: Ropivacaine; Other Names: Dexamethasone; Adrenalin; Ketorolac
Active Comparator: Local infiltrationanalgesia; Ropivacaine, Adrenalin and Ketorolac combined with systemic high dose dexamethasone	Drug: Ropivacaine; Other Names: Dexamethasone; Adrenalin; Ketorolac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Opioid consumption	0 - 20 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption		0 - 24 hours postoperatively
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
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
Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)	Recorded at PCA(patient-controlled-analgesia) pump	0-24 hours postoperatively
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
Number of vomiting		0- 20 hours and 0-24 hours postoperatively
Consumption of Ondansetron		0-20 hours and 0-24 hours
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.
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
Discharge time from the hospital		maximum 60 hour postoperatively.
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
Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.		0-24 hours posteratively

Collaborators and Investigators

• Sponsor: Regionshospitalet Silkeborg
• Investigators: Study Director: Charlotte Runge, MD, Regionalhospital Silkeborg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: February 22, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Estimate): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Dexamethasone; Peripheral nerve block; Total knee Arthroplasty
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Ketorolac; Ropivacaine
• Other Study ID Numbers: 2014-003343-35