An observational study in Cesarean Section and Anesthesia, Obstetric, sponsored by Oregon Health and Science University. Enrolling by invitation at 1 site in United States. Open to female participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Oregon Health and Science University · Observational
This will be a prospective, observational, single-center study to evaluate the accuracy of sensory testing by blunt 16-gauge plastic cannula during the 15 minutes after spinal injection for predicting spinal failure. While previous studies assessed the minimal sensory level required for painless cesarean delivery at skin incision or delivery, no studies have assessed the accuracy of sensory testing at an earlier time point.
Primary Objective:
Secondary Objectives:
A sample size calculation
Population: 250 pregnant females undergoing non-emergency cesarean section delivery in the Labor \& Delivery Operating Rooms at Oregon Health \& Science University.
Number of Sites: Single center trial
Study Duration: Institutional Review Board approval has been obtained. Study initiation, enrollment, and data collection is expected to take 24 months. Data analysis, manuscript writing, editing, submission and revision to a peer-reviewed journal is expected to take an additional 6 months.
In summary, the study should be completed in under 3 years.
Subject Participation Duration: Total time of subject participation including time for recruitment, enrollment, data collection during the preanesthesia consult, and post-consult data collection will be less than 3 hours.
Estimated Time to Complete Enrollment: Estimated time from enrollment into study of the first subject to enrollment into study of the last subject is 24 months.
Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant females receiving spinal or combined spinal epidural anesthesia for cesarean delivery
Exclusion Criteria:
Healthy pregnant women of BMI between 20 and 40 kg/m2, height between 5 feet 2 inches and 5 feet 10 inches, who are having cesarean delivery under spinal or combined spinal epidural anesthesia.
Drug: Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine
Patients will receive standard intrathecal medications for urgent and scheduled cesarean delivery at the study site. All study subjects will receive bupivacaine, fentanyl, and morphine.
Also known as: Marcaine
Number of participants with spinal failure
A composite outcome that will be categorized as "yes" if there is either preoperative or intraoperative spinal failure. Preoperative failure will be defined as failure to achieve a T4 level to pinprick by the 15-minute timepoint. Intraoperative failure will be defined as pain (VAS \> 0) that requires anesthesia provider medication administration. Pain will be queried at time of skin incision, fetal delivery, uterine exteriorization, uterine interiorization or end of uterine closure, and end of skin closure. If VAS \> 0, the anesthesia provider will ask the patient if they would like analgesic medication. Discomfort at any other time during the cesarean delivery that is treated with neuraxial or intravenous analgesia will also count. Pain will be rated according to the scale: 0 = no pain, 10 = worst pain imaginable
Time frame: 90 minutes
Number of participants with conversion to another anesthetic technique
Conversion to general anesthesia or activation of the epidural catheter for intraoperative pain
Time frame: 90 minutes
Number of participants with inadequate anesthesia
Analgesic supplementation with ketamine, \> 20 mg propofol, \> 2 mg midazolam, \> 10 mg parental morphine equivalents, or intraperitoneal chloroprocaine
Time frame: 90 minutes
Patient satisfaction assessed by 5-point Likert scale, minimum value=1, maximum value=5, with higher values representing better patient satisfaction
Patient satisfaction upon arrival to the post-anesthesia care unit, rated on a 1-5 Likert scale with higher values representing better patient satisfaction
Time frame: 2 Hours
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Due to patient data protection regulations within the study site there is not a plan to make individual participant data available to other researchers. Reasonable requests emailed to the PI will considered on a case-by-case basis.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Oregon Health and Science University