Fascial Closure and Post-caesarean Pain

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Cesarean Section; Post-operative Pain; Fascial Closure; Surgical Technique
• Intervention / Treatment: Procedure: Fascial closure method during caesarean section via pfannenstiel incision.

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:

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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard J Pittini, MD; Phone Number: 416-480-4579; Email: richard.pittini@sunnybrook.ca
• Study Contact Backup: Name: Sandeep S Sandhu, MBChB; Phone Number: 647-764-0630; Email: ss.sandhu@mail.utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single suture, knot above fascia; 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.	Procedure: Fascial closure method during caesarean section via pfannenstiel incision.; Comparison of three different methods of fascial closure.
Active Comparator: Two sutures, knot above fascia; 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.	Procedure: Fascial closure method during caesarean section via pfannenstiel incision.; Comparison of three different methods of fascial closure.
Active Comparator: Two sutures, buried knots below fascia; 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.	Procedure: Fascial closure method during caesarean section via pfannenstiel incision.; Comparison of three different methods of fascial closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Analgesia use	Will record opioid and non-opioid analgesia use as participants remain in hospital.	48-72 hours

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cesarean Section; Surgical Technique; Pregnancy-Related; Post-operative Pain; Fascial Closure
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: FAS-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No