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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Blood Loss Anemia, Postoperative Pain, Pregnancy

Intervention / Treatment
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* Procedure: non-dissection of inferior rectus sheath
* Procedure: control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery | Procedure: non-dissection of inferior rectus sheath<br>* Non-dissection of inferior rectus sheath<br>|
| Placebo Comparator: Control<br>Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery | Procedure: control<br>* Dissection of inferior and superior aspect of the rectus sheath<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative hemoglobin | assessment of drop in hemoglobin post-operatively compared to pre-operative values | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of Visual Analog Scale (VAS) scores in first 72 hours | assessment of VAS scores and | 72 hours | 
| Assessment of total narcotic use, expressed as morphine equivalents |  | 72 hours |