Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.
- Registration Number
- NCT02728310
- Lead Sponsor
- San Salvatore Hospital of L'Aquila
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 96
- 18-90 years of age
- American Society of Anaesthesiologists (ASA) physical status I-III
- total hip arthroplasty.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levobupivacaine infusion Levobupivacaine 1500 mg of Levobupivacaine by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected. Saline infusion Saline 300 ml of Saline (for Levobupivacaine as placebo) by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected.
- Primary Outcome Measures
Name Time Method Incident and rest pain (using VAS score) at 72 hours after surgery 72 hours The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
- Secondary Outcome Measures
Name Time Method Side effects (PONV) at 72 hours after surgery 72 hours Time to have post-operative nausea and vomiting (in minutes)
Wound healing at 72 hours 72 hours Number of infections of surgical wound.
Consumption of painkillers (in mg) at 72 hours after surgery 72 hours The equianalgesic dose (in mg) of morphine
Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery 72 hours Presence or not of epilepsy
Improvement of rehabilitation at 72 hours 72 hours Our total hip arthroplasy rehabilitation protocol is focused on the following manoeuvres: contraction of the gluteal and quadricipital muscles, passive and active mobilization of the hip joint, passive and active mobilization of the knee and walking with crutches and a walker.the improvement of rehabilitation manoeuvres has been evaluated in a four-step scale: 0-no improvement; 1- slight improvement, 2- good improvement; 3- great improvement.