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

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University Hospitals (UH)

Status

Terminated

Conditions

Postoperative Pain
Acute Blood Loss Anemia
Pregnancy

Treatments

Procedure: control
Procedure: non-dissection of inferior rectus sheath

Study type

Interventional

Funder types

Other

Identifiers

NCT02762773
UHCASEMC2

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

81 participants in 2 patient groups, including a placebo group

Experimental
Experimental group
Description:
Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery
Treatment:
Procedure: non-dissection of inferior rectus sheath
Control
Placebo Comparator group
Description:
Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery
Treatment:
Procedure: control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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