Clinical trial NCT02728310: Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.
Official title: Local Continuous Wound Infusion and Local Infusion of Anaesthetics in the Management of Post-operative Pain and Rehabilitation After Total Hip Arthroplasty: a Double-blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization through an additive or synergistic effect because it can maintain continuous inhibition of nociceptive afferents

Detailed description: Wound infiltration with local anesthetics is an analgesic technique that has been adopted for post-operative analgesia following a range of surgical orthopaedic procedures. Pain management by infusion of local aesthetic into wounds was found to improve pain, reduced opioid use and side effects, increase patient satisfaction, and shorten the hospital stay when compared to placebo or no treatment, but actually it was not definitively proven that wound infiltration provides additional analgesic or outcome benefit in the setting of a comprehensive multimodal analgesic approach. The hypothesis of this study is that a consistent amount of Levobupivacaine 0.5% for LCWI and LIA could provide a more extended postoperative analgesia for post-operative incident and rest pain with a better post-operative recovery and rehabilitation following THA, in the first 72 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* 18-90 years of age
* American Society of Anaesthesiologists (ASA) physical status I-III
* total hip arthroplasty.

Exclusion Criteria:

* pregnancy
* body mass index (BMI) \>35
* allergy to local anaesthetics
* skeletal and/or muscle abnormalities of the spine
* primary and/or secondary neurological diseases
* psychiatric diseases
* history of chronic pain and/or neuropathic disorders
* history of drug abuse
* state of sepsis
* infection and/or tumours within the skin on the back
* primary or secondary coagulopathies
* primary or secondary heart, liver and renal failure.

Primary outcomes:
measure: Incident and rest pain (using VAS score) at 72 hours after surgery
timeFrame: 72 hours
Secondary outcomes:
measure: Consumption of painkillers (in mg) at 72 hours after surgery
timeFrame: 72 hours
measure: Side effects (PONV) at 72 hours after surgery
timeFrame: 72 hours
measure: Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery
timeFrame: 72 hours
measure: Wound healing at 72 hours
timeFrame: 72 hours
measure: Improvement of rehabilitation at 72 hours
timeFrame: 72 hours
Other outcomes:
Locations:
Study officials:
affiliation: Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
name: Pierfrancesco Fusco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Konopka JF, Hansen VJ, Rubash HE, Freiberg AA. Risk assessment tools used to predict outcomes of total hip and total knee arthroplasty. Orthop Clin North Am. 2015 Jul;46(3):351-62, ix-x. doi: 10.1016/j.ocl.2015.02.004. Epub 2015 Mar 24.
citation: Di Puccio F, Mattei L. Biotribology of artificial hip joints. World J Orthop. 2015 Jan 18;6(1):77-94. doi: 10.5312/wjo.v6.i1.77. eCollection 2015 Jan 18.