Cesarian Section, Pain Score Reduction
Conditions
Keywords
Cesarian Section, Pain Score Reduction, Opiod use
Brief summary
This proposed prospective, randomized, single-blinded controlled trial will directly compare Stratafix anti-microbial barbed sutures and standard PDS sutures for fascial closure at the time of Cesarean delivery. Primary outcomes will include postoperative pain scores at 24 hours, 48 hours, and two weeks postpartum (both total pain and right-sided abdominal pain commonly associated with the knot from traditional fascial closure), as well as total opioid consumption (morphine milligram equivalents) for the first 48 hours. Secondary outcomes will include length of hospital stay, wound complications (e.g., infection, dehiscence), patient satisfaction measured per the standardized surgical satisfaction questionnaire (SSQ-8), time required for fascial closure (minutes from start to end of fascial closure), and surgical site infections. The hypothesis is that among women undergoing primary Cesarean delivery, fascial closure with barbed suture (Stratafix) will result in lower postoperative pain scores and reduced opioid (narcotic) consumption within the first 48 hours after surgery compared to closure with traditional monofilament suture (PDS).
Detailed description
This prospective, randomized, single-blinded controlled trial will compare Stratafix™ antimicrobial barbed sutures with standard PDS monofilament sutures for fascial closure at Cesarean delivery, evaluating whether barbed sutures improve postoperative recovery. Primary outcomes include postoperative pain scores at 24 hours, 48 hours, and two weeks-capturing both overall pain and the right-sided discomfort often associated with fascial knot placement-as well as total opioid use in the first 48 hours (measured in MMEs). Secondary outcomes include length of hospital stay, wound complications, surgical site infections, fascial closure time, and patient-reported satisfaction using the SSQ-8. The study hypothesizes that barbed suture closure will result in lower pain and reduced opioid consumption compared with traditional PDS closure among women undergoing primary Cesarean delivery.
Interventions
DEVICEPolydioxanone Plus
Polydioxanone Plus (PDS) is a standard monofilament, absorbable suture used for fascial closure at the time of Cesarean delivery. In this study, PDS will be used to approximate the rectus fascia in a continuous running fashion with a traditional terminal knot. This intervention represents the conventional method of fascial closure and serves as the control arm for comparison against Stratafix barbed suture
DEVICEPolydioxanone (PDS)
Polydioxanone (PDS) is a standard monofilament, absorbable suture used for fascial closure at the time of Cesarean delivery. In this study, PDS will be used to approximate the rectus fascia in a continuous running fashion with a traditional terminal knot. This intervention represents the conventional method of fascial closure and serves as the control arm for comparison against Stratafix barbed suture.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women of reproductive age ( ≥18 years old to ≤ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≥37 weeks of gestation.
Exclusion criteria
* Women of reproductive age (≤ 18 years old to ≥ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≤ 37 weeks of gestation. * Emergent Cesarean delivery * Chronic opioid use or pain disorders * Allergy to suture materials * Previous classical Cesarean section * Intraoperative complications (e.g. hemorrhage, uterine rupture, injury)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | 24 hours, 48 hours, and two weeks postpartum | Primary outcomes will include postoperative pain scores at 24 hours, 48 hours, and two weeks postpartum (both total pain and right-sided abdominal pain commonly associated with the knot from traditional fascial closure), as well as total opioid consumption (morphine milligram equivalents) for the first 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | First 48 hours after surgery | Secondary outcomes will include length of hospital stay, wound complications (e.g., infection, dehiscence), patient satisfaction measured per the standardized surgical satisfaction questionnaire (SSQ-8), time required for fascial closure (minutes from start to end of fascial closure), and surgical site infections. The hypothesis is that among women undergoing primary Cesarean delivery, fascial closure with barbed suture (Stratafix) will result in lower postoperative pain scores and reduced opioid (narcotic) consumption within the first 48 hours after surgery compared to closure with traditional monofilament suture (PDS). |
Contacts
CONTACTAnna Valencia, MPH
CONTACTStephanie Marsh Marsh, MPH
PRINCIPAL_INVESTIGATORKathleen Curley, MD
University of Arizona
Outcome results
None listed