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

About this trial
This is an interventional prevention trial for Pain
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.
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
NCT ID
NCT02728310
First Posted
March 15, 2016
Last Updated
August 10, 2020
Sponsor
San Salvatore Hospital of L'Aquila
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
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Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.
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