Clinical trial NCT04999670: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Cesarean Section
Post-operative Pain
Fascial Closure
Surgical Technique
Keywords: Pregnancy-Related
Cesarean Section
Post-operative Pain
Fascial Closure
Surgical Technique
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised into one of three groups based upon the method of fascial closure prior to their caesarean section.
Primary purpose: OTHER

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:

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.

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

Primary outcomes:
measure: Visual Analogue Score for Pain
timeFrame: Post-operative day #1 and 2, 2, 6, and 10 weeks post-operatively.
measure: Analgesia use
timeFrame: 48-72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: