Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss

Postoperative Pain Clinical Trial

Official title:

Does Avoiding Inferior Rectus Sheath Dissection Lead to Decreased Operative Blood Loss and Operating Time Without Increasing Delivery of Fetus in Primary Cesarean Delivery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02762773
• Other study ID #: UHCASEMC2
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2021
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of non-dissecting the inferior rectus sheath during primary cesarean delivery on post-operative hemoglobin and post-operative pain control as measured by VAS score and opioid anesthesia use in the first 72 hours post-op.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• - Patients must be 18 years or older as well as willing and able to provide informed consent
• Patients undergoing a scheduled or non-scheduled, non-urgent or non-scheduled urgent (delivery within 30 minutes of decision for surgical delivery) Cesarean delivery between >35 weeks gestational age,
• Patients who are expected to receive a Pfannenstiel incision
• Patients with viable singleton intra-uterine pregnancy
• Patients with fetus in cephalic presentation

Exclusion Criteria:

• - Patients younger than 18 years,
• Patients unable or unwilling to provide informed consent,
• Patients who are illiterate,
• Patients who are non-English speaking or reading,
• Patients who are medical or nursing students at a school affiliated with University Hospital
• Multi-fetal gestations (>1 intrauterine pregnancy),
• Patients with a BMI >50 kg/m^2
• Patients with a suspected placenta accreta or placenta previa
• patients with 2 prior cesarean deliveries
• Patient undergoing emergent cesarean delivery (delivery within 10 minutes of decision for surgical delivery)
• Patients who will require a vertical skin incision, Maylard or Cherney incisions
• Patients with a history of significant pelvic adhesive disease, as determined by prior operative reports
• Patients with fetus in non-cephalic presentation
• Patients with pre-gestational or gestational diabetes mellitus
• Patients with estimated fetal weight >5000 grams
• Patients with estimated fetal weight <10% for gestational age
• Patients with who require general anesthetic
• Patients who are on chronic pain medication
• Patients with a history of drug abuse

Related Conditions & MeSH terms

• Acute Blood Loss Anemia
• Hemorrhage
• Postoperative Pain
• Pregnancy

Intervention

Procedure:
• non-dissection of inferior rectus sheath
Non-dissection of inferior rectus sheath
• control
Dissection of inferior and superior aspect of the rectus sheath

Locations

Country	Name	City	State
United States	UH Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Martin Wieczorek

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative hemoglobin	assessment of drop in hemoglobin post-operatively compared to pre-operative values	24 hours
Secondary	assessment of Visual Analog Scale (VAS) scores in first 72 hours	assessment of VAS scores and	72 hours
Secondary	Assessment of total narcotic use, expressed as morphine equivalents		72 hours