Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728310
Recruitment Status : Terminated (Terminated)
First Posted : April 5, 2016
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Emiliano Petrucci, San Salvatore Hospital of L'Aquila

Tracking Information
First Submitted Date  ICMJE March 15, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date August 12, 2020
Study Start Date  ICMJE September 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
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").
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
Incident and rest pain (using VAS score) at 72 hours after surgery [ Time Frame: 72 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • Consumption of painkillers (in mg) at 72 hours after surgery [ Time Frame: 72 hours ]
  • Side effects (PONV) at 72 hours after surgery [ Time Frame: 72 hours ]
  • Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery [ Time Frame: 72 hours ]
  • Wound healing at 72 hours (number of infections of surgical wound) [ Time Frame: 72 hours ]
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Levobupivacaine
    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
  • Drug: Saline
    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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Levobupivacaine
  • 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.
    Intervention: Drug: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 4, 2016)
96
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728310
Other Study ID Numbers  ICMJE 0080580/12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emiliano Petrucci, San Salvatore Hospital of L'Aquila
Study Sponsor  ICMJE San Salvatore Hospital of L'Aquila
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierfrancesco Fusco, MD Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
PRS Account San Salvatore Hospital of L'Aquila
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP