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Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section

Primary Purpose

Pain

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levobupivacaine
Saline
Sponsored by
Emiliano Petrucci
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Caesarian Section. The Pfannenstiel incision was performed.

Exclusion Criteria:

  • body mass index (BMI) >35
  • allergy to local anesthetics
  • 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 tumors within the skin on the back
  • primary or secondary coagulopathies
  • pre-eclampsia or eclampsia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Levobupivacaine 100 mg, USG TAP Block

    Placebo

    Arm Description

    100 mg of Levobupivacaine by intramuscular injection, at the end of surgery

    20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery

    Outcomes

    Primary Outcome Measures

    Postoperative pain (Numeric Rate Scale) 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

    Patient satisfaction at 72 hours from surgery
    Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied)
    The time of recovery of bowel function at 72 hours from surgery
    Time (in hours) to have defacation
    The time of hospital discharge at 72 hours after surgery
    Time (days after surgery) for hospital discharging
    The consumption of painkillers at 72 hours after surgery
    The equianalgesic dose (in mg) of morphine.
    The healing of the surgical wound at 72 hours
    Descriptive scale of four step: unacceptable/acceptable/excellent healing

    Full Information

    First Posted
    March 15, 2016
    Last Updated
    August 10, 2020
    Sponsor
    Emiliano Petrucci
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02728323
    Brief Title
    Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section
    Official Title
    Ultrasound-guided Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section: 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
    October 2013 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Emiliano Petrucci

    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
    In many countries, caesarean section (CS) rates have been increasing. The international literature is unclear regarding the analgesic efficacy of the transversus abdominis plane block (TAPB) after a CS. In particular, no clinical trials exist in which the correct method of performing this block has been matched with the obtained analgesic effect after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery
    Detailed Description
    Transversus abdominis plane block (TAPB) is a regional anesthetic technique that can provide analgesia for lower abdominal surgical procedures. Previous meta-analyses and recently published clinical trials have demonstrated promising results for this technique when it is used as part of multimodal postoperative pain treatment, but no consensus exists regarding the potency of this type of anesthetic procedure for analgesia after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery. In this study, the correct execution of an USG-TAPB was verified, and then the procedure was matched with the obtained analgesic effect after a CS. The secondary aims were to determine whether USG-TAPB could ensure a decline in postoperative requests for opiates and fewer opiate-related side effects, the return of faster bowel function, and shorter recovery time without generating critical hemodynamic changes.

    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 100 mg, USG TAP Block
    Arm Type
    Active Comparator
    Arm Description
    100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Levobupivacaine
    Other Intervention Name(s)
    Chirocaine
    Intervention Description
    100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Other Intervention Name(s)
    Saline solution
    Intervention Description
    20 ml of saline saline by intramuscular injection, at the end of surgery
    Primary Outcome Measure Information:
    Title
    Postoperative pain (Numeric Rate Scale) 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
    Patient satisfaction at 72 hours from surgery
    Description
    Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied)
    Time Frame
    72 hours
    Title
    The time of recovery of bowel function at 72 hours from surgery
    Description
    Time (in hours) to have defacation
    Time Frame
    72 hours
    Title
    The time of hospital discharge at 72 hours after surgery
    Description
    Time (days after surgery) for hospital discharging
    Time Frame
    72 hours
    Title
    The consumption of painkillers at 72 hours after surgery
    Description
    The equianalgesic dose (in mg) of morphine.
    Time Frame
    72 hours
    Title
    The healing of the surgical wound at 72 hours
    Description
    Descriptive scale of four step: unacceptable/acceptable/excellent healing
    Time Frame
    72 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III Caesarian Section. The Pfannenstiel incision was performed. Exclusion Criteria: body mass index (BMI) >35 allergy to local anesthetics 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 tumors within the skin on the back primary or secondary coagulopathies pre-eclampsia or eclampsia.
    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
    27906937
    Citation
    Fusco P, Cofini V, Petrucci E, Scimia P, Pozone T, Paladini G, Carta G, Necozione S, Borghi B, Marinangeli F. Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome after Caesarean Section: A Randomized Controlled Clinical Trial. Pain Physician. 2016 Nov-Dec;19(8):583-591.
    Results Reference
    derived

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    Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section

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