Fascial Closure and Post-caesarean Pain

Pregnancy Related Clinical Trial

Official title:

Post-operative Pain in Patients Undergoing Caesarean Section: Randomised Trial Evaluating Three Methods of Fascial Closure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04999670
• Other study ID #: FAS-101
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cesarean Section
• Fascial Closure
• Pain, Postoperative
• Post-operative Pain
• Pregnancy Related
• Surgical Technique

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