Fascial Closure and Post-caesarean Pain

NCT04999670 | Unknown

• 1 other identifier: FAS-101
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Related; Cesarean Section; Post-operative Pain; Fascial Closure; Surgical Technique

Keywords

Pregnancy-Related; Cesarean Section; Post-operative Pain; Fascial Closure; Surgical Technique

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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.

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.

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.

Procedure: Fascial closure method during caesarean section via pfannenstiel incision.

Interventions

Fascial closure method during caesarean section via pfannenstiel incision. PROCEDURE

Comparison of three different methods of fascial closure.

Single suture, knot above fascia; Two sutures, buried knots below fascia; Two sutures, knot above fascia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Multiple pregnancy
• General anaesthesia
• Caesarean section through laparotomy incision
• History of chronic pain

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Richard J Pittini, MD

CONTACT

416-480-4579; richard.pittini@sunnybrook.ca

Sandeep S Sandhu, MBChB

CONTACT

647-764-0630; ss.sandhu@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will not be made aware which method of fascial closure group they will be in, and investigators will also be blinded to the method of fascial closure as they approach participants to fill in their follow-up questionnaires.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician and Gynaecologist

Model Details: Participants will be randomised into one of three groups based upon the method of fascial closure prior to their caesarean section.

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: August 11, 2021
• Study Start: September 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share