Clinical trial NCT03698006: Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery
Official title: Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Knee Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for a total knee arthroplasty under spinal block.
* Patient with a weight above 40kg.

Exclusion Criteria:

* Patient with ASA IV status.
* Contraindication to spinal block, or peripheral nerve blocks.
* Neurological deficit of the lower limb.
* Patient with renal dysfunction.
* Patient with chronic pain, opioid consumption or alcohol consumption.
* Pregnancy.

Primary outcomes:
measure: Total morphine consumption (mg)
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total morphine consumption (mg)
timeFrame: 2 hours, 48 hours and 72 hours postoperatively
measure: Analgesic duration (minutes)
timeFrame: Postoperative day 0
measure: Pain scores (numeric rating scale, 0-10) at rest and on movement
timeFrame: 2 hours, 24 hours, 48 hours and 72 hours postoperatively
measure: Rate of postoperative nausea and vomiting
timeFrame: 2 hours, 24 hours, 48 hours and 72 hours postoperatively
measure: Rate of prurit
timeFrame: 2 hours, 24 hours, 48 hours and 72 hours postoperatively
measure: Active flexion
timeFrame: 24hours, 48hours and 72hours postoperatively
measure: Passive flexion
timeFrame: 24hours, 48hours and 72hours postoperatively
measure: Quadriceps muscle strength (numeric scale, 1-5)
timeFrame: 24hours, 48hours and 72hours postoperatively
measure: Distance walked (meters)
timeFrame: 24hours, 48hours and 72hours postoperatively
measure: Complication of tibial nerve block
timeFrame: up to 1 week
measure: Length of stay in hospital
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Eric Albrecht
state: English
Study officials:
References:
citation: Sinha SK, Abrams JH, Arumugam S, D'Alessio J, Freitas DG, Barnett JT, Weller RS. Femoral nerve block with selective tibial nerve block provides effective analgesia without foot drop after total knee arthroplasty: a prospective, randomized, observer-blinded study. Anesth Analg. 2012 Jul;115(1):202-6. doi: 10.1213/ANE.0b013e3182536193. Epub 2012 Apr 27.