Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.
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|ClinicalTrials.gov Identifier: NCT02728310|
Recruitment Status : Terminated (Terminated)
First Posted : April 5, 2016
Last Update Posted : August 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Levobupivacaine Drug: Saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Start Date :||September 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: Levobupivacaine infusion
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.
An infusion rate of 10 ml/h of 1500 mg of 0.5 % of levobupivacaine for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.
Other Name: Chiracaine
Placebo Comparator: Saline infusion
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.
An infusion rate of 10 ml/h of 300 ml of saline solution for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.
Other Name: Saline solution
- Incident and rest pain (using VAS score) at 72 hours after surgery [ Time Frame: 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").
- Consumption of painkillers (in mg) at 72 hours after surgery [ Time Frame: 72 hours ]The equianalgesic dose (in mg) of morphine
- Side effects (PONV) at 72 hours after surgery [ Time Frame: 72 hours ]Time to have post-operative nausea and vomiting (in minutes)
- Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery [ Time Frame: 72 hours ]Presence or not of epilepsy
- Wound healing at 72 hours [ Time Frame: 72 hours ]Number of infections of surgical wound.
- Improvement of rehabilitation at 72 hours [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728310
|Principal Investigator:||Pierfrancesco Fusco, MD||Anesthesia and Intensive care Unit, San Salvatore Academic Hospital|