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Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section (TAP-CAT)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
USG-TAP block
CIC
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent,
  • Age>/=18 years,
  • Caesarean section under spinal or epidural anaesthesia
  • Technique surgical "Cohen Stark méthod".

Exclusion Criteria:

  • Patient refusal,
  • Patient under guardianship,
  • Contraindication to one of the two techniques,
  • Cesarean section under general anesthesia
  • Allergies to local anesthetics
  • Maternal instability

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Spinal-anesthesia

    Epidural-anesthesia

    Arm Description

    Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC

    Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC

    Outcomes

    Primary Outcome Measures

    Postoperative standing pain at day 2
    Assessment of Pain on Mobilization by a Numeric Scale of Pain

    Secondary Outcome Measures

    standing and resting pain measured during the first 3 days
    Assessment of Pain by a Numeric Scale of Pain
    Cumulative dose of Tramadol during the first 3 days
    Cumulative dose of nefopam during the first 3 days
    Cumulative dose of oxycodone during the first 3 days
    patient comfort assessed daily by visual analogic scale
    by visual analogic scale

    Full Information

    First Posted
    March 31, 2017
    Last Updated
    August 31, 2020
    Sponsor
    University Hospital, Caen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03102515
    Brief Title
    Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section
    Acronym
    TAP-CAT
    Official Title
    Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section: a Randomized Trial. (TAP-CAT Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 29, 2016 (Actual)
    Primary Completion Date
    October 26, 2016 (Actual)
    Study Completion Date
    October 26, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Caen

    4. Oversight

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

    5. Study Description

    Brief Summary
    Analgesia following surgery associates different intra-venous or oral analgesic drugs and sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be administered as a complement. In the specific context of caesarean sections, pain control is mandatory to enable the mother to take care of her offspring and shorten their hospital stay. This intervention is mainly performed under neuraxial anaesthesia (spinal or epidural), enabling the injection of morphine in the subdural or epidural space, as part of a multimodal analgesia regimen. Studies have evaluated continuous wound infiltration catheters (CIC) and ultrasound-guided (UGD) transabdominis plane (TAP) block, and both techniques and both techniques reduce postoperative morphine consumption. Recent studies have compared the two techniques and found conflicting results. Furthermore, they did not consider caesarean section performed under epidural analgesia, with a different neuraxial injection site, neither did they compared pain after postoperative day 2. Consequently, the aim of this study was to compare resting and standing pain up to postoperative day 3 after caesarean section performed under spinal or epidural anaesthesia and receiving either USG-TAP block or CIC. Baseline hypothesis was that the continuous infiltration provided a better analgesia at day 2.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Sequential Assignment
    Allocation
    Randomized
    Enrollment
    109 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Spinal-anesthesia
    Arm Type
    Other
    Arm Description
    Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
    Arm Title
    Epidural-anesthesia
    Arm Type
    Other
    Arm Description
    Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC
    Intervention Type
    Drug
    Intervention Name(s)
    USG-TAP block
    Intervention Type
    Drug
    Intervention Name(s)
    CIC
    Primary Outcome Measure Information:
    Title
    Postoperative standing pain at day 2
    Description
    Assessment of Pain on Mobilization by a Numeric Scale of Pain
    Time Frame
    Evaluate standing pain at 48 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    standing and resting pain measured during the first 3 days
    Description
    Assessment of Pain by a Numeric Scale of Pain
    Time Frame
    Evaluate pain at during 3 days postoperatively
    Title
    Cumulative dose of Tramadol during the first 3 days
    Time Frame
    during the first 3 days
    Title
    Cumulative dose of nefopam during the first 3 days
    Time Frame
    during the first 3 days
    Title
    Cumulative dose of oxycodone during the first 3 days
    Time Frame
    during the first 3 days
    Title
    patient comfort assessed daily by visual analogic scale
    Description
    by visual analogic scale
    Time Frame
    during the first 3 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Informed consent, Age>/=18 years, Caesarean section under spinal or epidural anaesthesia Technique surgical "Cohen Stark méthod". Exclusion Criteria: Patient refusal, Patient under guardianship, Contraindication to one of the two techniques, Cesarean section under general anesthesia Allergies to local anesthetics Maternal instability

    12. IPD Sharing Statement

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