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

NCT02762773 | Terminated DMC

• 1 other identifier: UHCASEMC2
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Blood Loss Anemia; Postoperative Pain; Pregnancy

Outcome Measures

Primary Outcomes (1)

• post-operative hemoglobin

  assessment of drop in hemoglobin post-operatively compared to pre-operative values

  24 hours

Secondary Outcomes (2)

• assessment of Visual Analog Scale (VAS) scores in first 72 hours

  72 hours

• Assessment of total narcotic use, expressed as morphine equivalents

  72 hours

Study Arms (2)

Experimental

EXPERIMENTAL

Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery

Procedure: non-dissection of inferior rectus sheath

Control

PLACEBO COMPARATOR

Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery

Procedure: control

Interventions

non-dissection of inferior rectus sheath PROCEDURE

Non-dissection of inferior rectus sheath

Experimental

control PROCEDURE

Dissection of inferior and superior aspect of the rectus sheath

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Martin Wieczorek: collaborator

Study Sites (1)

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin Wieczorek, MD

  University Hospitals Cleveland Medical Center

  STUDY DIRECTOR

• Melissa March, MD

  University Hospitals Cleveland Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: February 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

US (1)