Pregnancy RelatedNCT04999670
Fascial Closure and Post-caesarean Pain
A study testing Fascial closure method during caesarean section via pfannenstiel incision. in people with Pregnancy Related and Cesarean Section, run by Sunnybrook Health Sciences Centre.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Cesarean Section, Post-operative Pain
- What is being tested?
- Fascial closure method during caesarean section via pfannenstiel incision.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Multiple pregnancy
- General anaesthesia
- Caesarean section through laparotomy incision
- History of chronic pain
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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
- Pregnancy Related, Cesarean Section, Post-operative Pain, Fascial Closure, Surgical Technique
- Being tested
- Fascial closure method during caesarean section via pfannenstiel incision.
- Keywords
- Pregnancy-Related, Cesarean Section, Post-operative Pain, Fascial Closure, Surgical Technique
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial closure method during caesarean section via pfannenstiel incision.Procedure or surgery
Comparison of three different methods of fascial closure.
| Study group | Role | What they receive |
|---|---|---|
| Single suture, knot above fascia | Active comparator | 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. Receives: Procedure: Fascial closure method during caesarean section via pfannenstiel incision. |
| Two sutures, knot above fascia | Active comparator | 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. Receives: Procedure: Fascial closure method during caesarean section via pfannenstiel incision. |
| Two sutures, buried knots below fascia | Active comparator | 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. Receives: Procedure: Fascial closure method during caesarean section via pfannenstiel incision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised into one of three groups based upon the method of fascial closure prior to their caesarean section.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Pittini, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999670
- Sponsor's protocol ID
- FAS-101
- Status last verified
- Aug 2021
- First submitted
- 22 Dec 2020
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain in Patients Undergoing Caesarean Section: Randomised Trial Evaluating Three Methods of Fascial Closure
- ClinicalTrials.gov ID
- NCT04999670
- Acronym / sponsor ID
- FAS-101
- Conditions
- Pregnancy Related, Cesarean Section, Post-operative Pain, Fascial Closure, Surgical Technique
- Keywords
- Pregnancy-Related, Cesarean Section, Post-operative Pain, Fascial Closure, Surgical Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will be randomised into one of three groups based upon the method of fascial closure prior to their caesarean section.
| Arm | Type | Receives |
|---|---|---|
| Single suture, knot above fascia | Active comparator | Procedure: Fascial closure method during caesarean section via pfannenstiel incision.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. |
| Two sutures, knot above fascia | Active comparator | Procedure: Fascial closure method during caesarean section via pfannenstiel incision.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. |
| Two sutures, buried knots below fascia | Active comparator | Procedure: Fascial closure method during caesarean section via pfannenstiel incision.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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- Multiple pregnancy
- General anaesthesia
- Caesarean section through laparotomy incision
- History of chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascial closure method during caesarean section via pfannenstiel incision.Comparison of three different methods of fascial closure. | Procedure or surgery | Single suture, knot above fascia, Two sutures, buried knots below fascia, Two sutures, knot above fascia |
Primary outcome
Visual Analogue Score for Pain
Time frame: Post-operative day #1 and 2, 2, 6, and 10 weeks post-operatively.
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.
Analgesia use
Time frame: 48-72 hours
Will record opioid and non-opioid analgesia use as participants remain in hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial closure method during caesarean section via pfannenstiel incision. in people with Pregnancy Related and Cesarean Section, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard J Pittini, MD (416-480-4579, richard.pittini@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score for Pain (time frame: Post-operative day #1 and 2, 2, 6, and 10 weeks post-operatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.