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

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

Condition or disease Intervention/treatment Phase
Pain Drug: Levobupivacaine Drug: Saline Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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").


Secondary Outcome Measures :
  1. Consumption of painkillers (in mg) at 72 hours after surgery [ Time Frame: 72 hours ]
    The equianalgesic dose (in mg) of morphine

  2. Side effects (PONV) at 72 hours after surgery [ Time Frame: 72 hours ]
    Time to have post-operative nausea and vomiting (in minutes)

  3. Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery [ Time Frame: 72 hours ]
    Presence or not of epilepsy

  4. Wound healing at 72 hours [ Time Frame: 72 hours ]
    Number of infections of surgical wound.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
San Salvatore Hospital of L'Aquila
Investigators
Layout table for investigator information
Principal Investigator: Pierfrancesco Fusco, MD Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Emiliano Petrucci, Anesthesist, San Salvatore Hospital of L'Aquila
ClinicalTrials.gov Identifier: NCT02728310    
Other Study ID Numbers: 0080580/12
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents