Hobsali: Protracted Effect of Combined Nerve Blocks After Total Knee Arthroplasty

Sponsor

Regionshospitalet Silkeborg (Other)

Overall Status

Completed

CT.gov ID

NCT02067078

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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:

1. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline, Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine (normal saline).
1. Saphenous block with active anesthetics and both Obturator nerve block and local block around the knee joint with placebo medicine (normal saline).
1. 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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty Pain Nerve Blocks	Drug: Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram Drug: Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram Drug: Ropivacaine + Toradol + Adrenaline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official 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.

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined saphenous nerve and obturator nerve block	Drug: Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram Dexamethasone 4 mg Clonidine 75 microgram Marcaine 90 mg Adrenaline 90 microgram
Experimental: Saphenous nerve block	Drug: Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram Dexamethasone 2 mg Clonidine 37,5 microgram Marcaine 45 mg Adrenaline 45 microgram
Active Comparator: Local infiltration analgesia	Drug: Ropivacaine + Toradol + Adrenaline Ropivacaine 300 mg + Toradol 45 mg + Adrenaline 0,75 mg

Arm

Intervention/Treatment

Experimental: Combined saphenous nerve and obturator nerve block

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

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

Experimental: Saphenous nerve block

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

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

Active Comparator: Local infiltration analgesia

Drug: Ropivacaine + Toradol + Adrenaline

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

Outcome Measures

Primary Outcome Measures

Opioid consumption [1 to 24 hours postoperatively]

Secondary Outcome Measures

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]
numeric rating scale with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable
Pain Score at rest [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
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 .]
numeric rating scale with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea
Vomiting [Number of between 24 hours postoperatively]
Ondansetron [Consumption at time 24 hours postoperative]
Number of nights with patient-reported sleep disruptions [Time 48 hours postoperatively]
Duration of stay in the post anesthesia care unit [1 - 48 hours postoperatively]
Discharge time from the hospital [Time 1 hour to 2 weeks postoperatively]
Patient-reported consumption of opioid [From the discharge date from hospital to ambulatory monitoring 2 weeks postoperatively]
Quantitative satisfaction of pain [At 2 weeks postoperatively]
By indicating satisfaction score (0-10 ) , where the value 0 = complete dissatisfaction and 10 = complete satisfaction.
Isometric tests of muscle strength in the hip adductors [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.
Time at mobilization to walk with or without support in the form of a walker, crutches or caregivers. [Time 1 to 48 hours postoperatively]
Timed Up and Go test [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 .
Cumulated Ambulation Score to illustrate the basic level of mobilization [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
Movement of the knee joint [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)