Clinical trial NCT02067078: Protracted Effect of Combined Nerve Blocks After Total Knee Arthroplasty
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Pain
Nerve Blocks
Keywords: nerve block
total knee arthroplasty
saphenous nerve block
obturator nerve block
pain
opioid consumption
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Opioid consumption
timeFrame: 1 to 24 hours postoperatively
Secondary outcomes:
measure: Opioid consumption
timeFrame: 1 to 48 hours postoperatively
measure: Pain Score by passive flexion of the knee joint from 0-90 degrees
timeFrame: Time 1, 2, 5, 7, 24, 31, 48 hours postoperatively
measure: Pain Score at rest
timeFrame: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively
measure: Patient-reported time to first postoperative breakthrough pain
timeFrame: Time 1 - 48 hours postoperatively
measure: Nausea
timeFrame: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively .
measure: Vomiting
timeFrame: Number of between 24 hours postoperatively
measure: Ondansetron
timeFrame: Consumption at time 24 hours postoperative
measure: Number of nights with patient-reported sleep disruptions
timeFrame: Time 48 hours postoperatively
measure: Duration of stay in the post anesthesia care unit
timeFrame: 1 - 48 hours postoperatively
measure: Discharge time from the hospital
timeFrame: Time 1 hour to 2 weeks postoperatively
measure: Patient-reported consumption of opioid
timeFrame: From the discharge date from hospital to ambulatory monitoring 2 weeks postoperatively
measure: Quantitative satisfaction of pain
timeFrame: At 2 weeks postoperatively
measure: Isometric tests of muscle strength in the hip adductors
timeFrame: 1-2 hours preoperatively and again 30 minutes after the application of obturator nerve blockade
measure: Time at mobilization to walk with or without support in the form of a walker, crutches or caregivers.
timeFrame: Time 1 to 48 hours postoperatively
measure: Timed Up and Go test
timeFrame: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively
measure: Cumulated Ambulation Score to illustrate the basic level of mobilization
timeFrame: 1-2 hours pre-operatively, during the first postoperative mobilization, and time 24 hours postoperatively
measure: Movement of the knee joint
timeFrame: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Regional hospital Silkeborg
state: Region Midt
Study officials:
References: