search
Back to results

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

Primary Purpose

Pain

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levobupivacaine
Saline
Sponsored by
San Salvatore Hospital of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Levobupivacaine infusion

    Saline infusion

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Incident and rest pain (using VAS score) at 72 hours after surgery
    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

    Consumption of painkillers (in mg) at 72 hours after surgery
    The equianalgesic dose (in mg) of morphine
    Side effects (PONV) at 72 hours after surgery
    Time to have post-operative nausea and vomiting (in minutes)
    Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery
    Presence or not of epilepsy
    Wound healing at 72 hours
    Number of infections of surgical wound.
    Improvement of rehabilitation at 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.

    Full Information

    First Posted
    March 15, 2016
    Last Updated
    August 10, 2020
    Sponsor
    San Salvatore Hospital of L'Aquila
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02728310
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    Terminated
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    San Salvatore Hospital of L'Aquila

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Levobupivacaine infusion
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Saline infusion
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    Levobupivacaine
    Other Intervention Name(s)
    Chiracaine
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Other Intervention Name(s)
    Saline solution
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incident and rest pain (using VAS score) at 72 hours after surgery
    Description
    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").
    Time Frame
    72 hours
    Secondary Outcome Measure Information:
    Title
    Consumption of painkillers (in mg) at 72 hours after surgery
    Description
    The equianalgesic dose (in mg) of morphine
    Time Frame
    72 hours
    Title
    Side effects (PONV) at 72 hours after surgery
    Description
    Time to have post-operative nausea and vomiting (in minutes)
    Time Frame
    72 hours
    Title
    Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery
    Description
    Presence or not of epilepsy
    Time Frame
    72 hours
    Title
    Wound healing at 72 hours
    Description
    Number of infections of surgical wound.
    Time Frame
    72 hours
    Title
    Improvement of rehabilitation at 72 hours
    Description
    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.
    Time Frame
    72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierfrancesco Fusco, MD
    Organizational Affiliation
    Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26043049
    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.
    Results Reference
    background
    PubMed Identifier
    25621213
    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.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs