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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04999670
Other study ID # FAS-101
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date June 30, 2022

Study information

Verified date August 2021
Source Sunnybrook Health Sciences Centre
Contact Richard J Pittini, MD
Phone 416-480-4579
Email richard.pittini@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. 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. 2. 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. 3. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date June 30, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Procedure:
Fascial closure method during caesarean section via pfannenstiel incision.
Comparison of three different methods of fascial closure.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Post-operative day #1 and 2, 2, 6, and 10 weeks post-operatively.
Primary Analgesia use Will record opioid and non-opioid analgesia use as participants remain in hospital. 48-72 hours
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