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Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bupivacaine
Lidocaine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing open upper abdominal surgery

Exclusion Criteria:

  • Bleeding diathesis
  • History of allergy to local anesthetics
  • Pregnancy/ lactation
  • Cardiovascular disease
  • Respiratory disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Epidural

    Lidocaine

    Arm Description

    Epidural catheters will be placed in the 9th or 10th thoracic intervertebral space prior to induction of anesthesia.Through the thoracic epidural catheter 0.125% bupivacaine at a rate of 5 mL/h will be infused. The infusion continues for 24h

    Intravenous lidocaine infusion will typically start in the operating room prior to induction of anesthesia at a rate of 2 to 3 mg/min. Postoperatively, the rate will be decreased to 0.5 to 1 mg/min. The infusion continues for 24h

    Outcomes

    Primary Outcome Measures

    Verbal Numeric Rating Score
    Verbal Numeric Rating Score is an 11-point scoring system used to assesses the postoperative pain level of the participants

    Secondary Outcome Measures

    B- endorphin level
    A measure for postoperative pain response compared to the baseline values
    FVC
    Forced Vital Capacity
    FEV1
    Forced Expiratory Volume

    Full Information

    First Posted
    December 25, 2016
    Last Updated
    December 6, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03005171
    Brief Title
    Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery
    Official Title
    Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    August 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in patients undergoing open upper abdominal surgery; when compared with thoracic epidural analgesia. Half of participants will receive intravenous lidocaine infusion, while the other half will receive thoracic epidural bupivacaine infusion.
    Detailed Description
    Postoperative pain is one of the commonest problems encountered by anaesthesiologists, especially after open abdominal surgeries, in which post-operative pain would cause a restrictive respiratory dysfunction, which is associated with poor postoperative outcomes. Despite the fact that epidural blocks provide superior analgesia; it is not often an ideal option as it frequently causes hypotension that may require excessive intravenous fluid administration, which is particularly deleterious after bowel surgery. Other complications include epidural hematoma and higher failure rate. Furthermore epidural analgesia may be contraindicated in some patients e.g. patients on certain anti-platelet therapy and patients refusing the technique. Other modalities to control postoperative pain are used e.g. intravenous analgesics and continuous wound infiltration, but none of which was proven to be as effective as epidural block. Whether perioperative lidocaine infusion is as effective as epidural block in reducing post-operative pain, is this study's concern. Some researches studied the efficacy of lidocaine infusion in controlling neuropathic as well as acute postoperative pain with encouraging results. Lidocaine infusion was found to reduce postoperative pain, opioid consumption and the length of hospital stay. Although risks of neurological and cardiac toxicity exist, these were not substantiated in the trials. Lidocaine has been described to have both analgesic, and anti-hyperalgesic effects6, as well as anti-inflammatory properties. It also accelerates the return of post-operative gastrointestinal function, which is of particular importance after major abdominal surgery. Opposite to opioids, which increase the incidence of nausea and vomiting, lidocaine decreases their incidence.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Epidural
    Arm Type
    Active Comparator
    Arm Description
    Epidural catheters will be placed in the 9th or 10th thoracic intervertebral space prior to induction of anesthesia.Through the thoracic epidural catheter 0.125% bupivacaine at a rate of 5 mL/h will be infused. The infusion continues for 24h
    Arm Title
    Lidocaine
    Arm Type
    Active Comparator
    Arm Description
    Intravenous lidocaine infusion will typically start in the operating room prior to induction of anesthesia at a rate of 2 to 3 mg/min. Postoperatively, the rate will be decreased to 0.5 to 1 mg/min. The infusion continues for 24h
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Marcaine
    Intervention Description
    Thoracic epidural bupivacaine infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Other Intervention Name(s)
    Xylocaine, Lidocaine Hydrochloride
    Intervention Description
    Intravenous lidocaine infusion
    Primary Outcome Measure Information:
    Title
    Verbal Numeric Rating Score
    Description
    Verbal Numeric Rating Score is an 11-point scoring system used to assesses the postoperative pain level of the participants
    Time Frame
    2-24 hours
    Secondary Outcome Measure Information:
    Title
    B- endorphin level
    Description
    A measure for postoperative pain response compared to the baseline values
    Time Frame
    Baseline-24 hours
    Title
    FVC
    Description
    Forced Vital Capacity
    Time Frame
    Baseline-24 hours
    Title
    FEV1
    Description
    Forced Expiratory Volume
    Time Frame
    Baseline-24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing open upper abdominal surgery Exclusion Criteria: Bleeding diathesis History of allergy to local anesthetics Pregnancy/ lactation Cardiovascular disease Respiratory disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Assiut University
    Organizational Affiliation
    Assiut University, Egypt
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery

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