Trials / Unknown
UnknownNCT04999670
Fascial Closure and Post-caesarean Pain
Post-operative Pain in Patients Undergoing Caesarean Section: Randomised Trial Evaluating Three Methods of Fascial Closure
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- Sunnybrook Health Sciences Centre · Academic / Other
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Fascial closure method during caesarean section via pfannenstiel incision. | Comparison of three different methods of fascial closure. |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2022-03-31
- Completion
- 2022-06-30
- First posted
- 2021-08-11
- Last updated
- 2021-08-11
Source: ClinicalTrials.gov record NCT04999670. Inclusion in this directory is not an endorsement.