Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02762773
Other study ID # UHCASEMC2
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Recruiting NCT06007378 - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery N/A
Recruiting NCT05943015 - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks N/A
Completed NCT04544228 - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy N/A
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03663478 - Continuous TQL Block for Elective Cesarean Section Phase 4
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT05170477 - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment N/A
Not yet recruiting NCT04561856 - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone Phase 4
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Completed NCT03612947 - TAP Block in Laparoscopic Cholecystectomy. Phase 2
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Active, not recruiting NCT04190355 - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain N/A
Recruiting NCT05145153 - Incidence of Chronic Pain After Thoracic Surgery
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A