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Fascial Closure and Post-caesarean Pain

Primary Purpose

Pregnancy Related, Cesarean Section, Post-operative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fascial closure method during caesarean section via pfannenstiel incision.
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pregnancy Related focused on measuring Pregnancy-Related, Cesarean Section, Post-operative Pain, Fascial Closure, Surgical Technique

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women with singleton pregnancy undergoing elective lower segment caesarean section via a Pfannenstiel incision.
  • Caesarean section done via regional anaesthesia (i.e. spinal regional anaesthesia, epidural anaesthesia, combo-spinal+epidural)

Exclusion Criteria:

  • Multiple pregnancy
  • General anaesthesia
  • Caesarean section through laparotomy incision
  • History of chronic pain

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Single suture, knot above fascia

    Two sutures, knot above fascia

    Two sutures, buried knots below fascia

    Arm Description

    Fascia sutured with #1 polysorb braided absorbable suture, with the knot being superficial to the fascia, starting at the left angle of the fascial incision and closed in a continuous fashion. The contralateral angle is grasped with a kocher clamp and the suture is then tied behind the angle ensuring adequate closure.

    Fascia sutured using #1 polysorb braided absorbable suture with a superficial knot, starting at the left angle and closed in a continuous fashion until the suture is above the right rectus abdominis muscle belly. A second #1 polysorb braided absorbable suture is tied behind the right angle with a superficial knot and run across in a continuous fashion to meet the opposing suture which are then tied together.

    Fascia sutured using #1 polysorb braided absorbable suture with a buried knot below the fascia starting at the left angle and closed in a continuous fashion until the suture overlies the right rectus abdominis muscle belly. A second #1 polysorb braided absorbable suture is then tied behind the right angle with a buried knot below the fascia and run across in a continuous fashion to meet the opposing suture which are then tied together.

    Outcomes

    Primary Outcome Measures

    Visual Analogue Score for Pain
    Participants will be asked to fill in a modified MD Anderson Brief Pain Inventory questionnaire with questions related to their overall pain using a visual analogue score ranking from 0 (no pain) to 10 (worst pain imaginable). A higher score will delineate poorer pain control. This questionnaire can be found the attached protocol under "Appendix C". The time points at which these will be measured is on post-operative day #1 and 2, as well as at 2, 6, and 10 weeks post-operatively. We aim to observe a change in the overall pain between groups.
    Analgesia use
    Will record opioid and non-opioid analgesia use as participants remain in hospital.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2020
    Last Updated
    August 9, 2021
    Sponsor
    Sunnybrook Health Sciences Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04999670
    Brief Title
    Fascial Closure and Post-caesarean Pain
    Official Title
    Post-operative Pain in Patients Undergoing Caesarean Section: Randomised Trial Evaluating Three Methods of Fascial Closure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    March 31, 2022 (Anticipated)
    Study Completion Date
    June 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sunnybrook Health Sciences Centre

    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
    This study will evaluate post-operative pain in patients undergoing elective caesarean sections based on the method of fascial closure. Patients will be randomised into one of three groups based upon the method of fascial closure and will be followed up over a 10 week period evaluating analgesia use in the acute setting, and also following up with pain scores using a visual analogue score throughout the follow-up period.
    Detailed Description
    Participants will be approached prior to their elective caesarean section to be consented. If they agree to be a part of the study, they will then be randomised into one of three groups based upon the method of fascial closure after delivery of the foetus and closure of the hysterotomy site: Fascia sutured with #1 polysorb braided absorbable suture, with the knot being superficial to the fascia, starting at the left angle of the fascial incision and closed in a continuous fashion. The contralateral angle is grasped with a kocher clamp and the suture is then tied behind the angle ensuring adequate closure. Fascia sutured using #1 polysorb braided absorbable suture with a superficial knot, starting at the left angle and closed in a continuous fashion until the suture is above the right rectus abdominis muscle belly. A second #1 polysorb braided absorbable suture is tied behind the right angle with a superficial knot and run across in a continuous fashion to meet the opposing suture which are then tied together. Fascia sutured using #1 polysorb braided absorbable suture with a buried knot below the fascia starting at the left angle and closed in a continuous fashion until the suture overlies the right rectus abdominis muscle belly. A second #1 polysorb braided absorbable suture is then tied behind the right angle with a buried knot below the fascia and run across in a continuous fashion to meet the opposing suture which are then tied together. The remainder of the caesarean section is completed in the standard fashion. Subsequent to this, patients are followed up with a modified brief pain inventory on post-operative day #1, day #7, day #14, day #42 and day #70 to evaluate their pain in the post-operative period. In addition, whilst being inpatients, participant's analgesia use is evaluated using the medication administration record within the unit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy Related, Cesarean Section, Post-operative Pain, Fascial Closure, Surgical Technique
    Keywords
    Pregnancy-Related, Cesarean Section, Post-operative Pain, Fascial Closure, Surgical Technique

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomised into one of three groups based upon the method of fascial closure prior to their caesarean section.
    Masking
    ParticipantInvestigator
    Masking Description
    Participants will not be made aware which method of fascial closure group they will be in, and investigators will also be blinded to the method of fascial closure as they approach participants to fill in their follow-up questionnaires.
    Allocation
    Randomized
    Enrollment
    450 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single suture, knot above fascia
    Arm Type
    Active Comparator
    Arm Description
    Fascia sutured with #1 polysorb braided absorbable suture, with the knot being superficial to the fascia, starting at the left angle of the fascial incision and closed in a continuous fashion. The contralateral angle is grasped with a kocher clamp and the suture is then tied behind the angle ensuring adequate closure.
    Arm Title
    Two sutures, knot above fascia
    Arm Type
    Active Comparator
    Arm Description
    Fascia sutured using #1 polysorb braided absorbable suture with a superficial knot, starting at the left angle and closed in a continuous fashion until the suture is above the right rectus abdominis muscle belly. A second #1 polysorb braided absorbable suture is tied behind the right angle with a superficial knot and run across in a continuous fashion to meet the opposing suture which are then tied together.
    Arm Title
    Two sutures, buried knots below fascia
    Arm Type
    Active Comparator
    Arm Description
    Fascia sutured using #1 polysorb braided absorbable suture with a buried knot below the fascia starting at the left angle and closed in a continuous fashion until the suture overlies the right rectus abdominis muscle belly. A second #1 polysorb braided absorbable suture is then tied behind the right angle with a buried knot below the fascia and run across in a continuous fashion to meet the opposing suture which are then tied together.
    Intervention Type
    Procedure
    Intervention Name(s)
    Fascial closure method during caesarean section via pfannenstiel incision.
    Intervention Description
    Comparison of three different methods of fascial closure.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Score for Pain
    Description
    Participants will be asked to fill in a modified MD Anderson Brief Pain Inventory questionnaire with questions related to their overall pain using a visual analogue score ranking from 0 (no pain) to 10 (worst pain imaginable). A higher score will delineate poorer pain control. This questionnaire can be found the attached protocol under "Appendix C". The time points at which these will be measured is on post-operative day #1 and 2, as well as at 2, 6, and 10 weeks post-operatively. We aim to observe a change in the overall pain between groups.
    Time Frame
    Post-operative day #1 and 2, 2, 6, and 10 weeks post-operatively.
    Title
    Analgesia use
    Description
    Will record opioid and non-opioid analgesia use as participants remain in hospital.
    Time Frame
    48-72 hours

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women with singleton pregnancy undergoing elective lower segment caesarean section via a Pfannenstiel incision. Caesarean section done via regional anaesthesia (i.e. spinal regional anaesthesia, epidural anaesthesia, combo-spinal+epidural) Exclusion Criteria: Multiple pregnancy General anaesthesia Caesarean section through laparotomy incision History of chronic pain
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Richard J Pittini, MD
    Phone
    416-480-4579
    Email
    richard.pittini@sunnybrook.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandeep S Sandhu, MBChB
    Phone
    647-764-0630
    Email
    ss.sandhu@mail.utoronto.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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