Cesarean Delivery Multicenter Intraoperative Discomfort
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-009840
About this study
The purpose of this study aims to estimate and characterize the incidence of intraoperative pain during cesarean deliveries. It is based on the premise that healthcare providers may not fully comprehend the genuine pain experienced by patients. The investigation seeks to control and cover pain management and enhance postoperative patient follow up.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Presence of intraoperative pain defined as answering “yes” to QI question 1.
- >18 years old, any viable gestation.
- Scheduled or unscheduled CD.
- Receiving neuraxial as planned primary mode of anesthesia (spinal, epidural and CSE).
- Also patient is to be inpatient at 24 (+/- 8) hours.
Exclusion Criteria:
- Patient refusal.
- Reported non-surgical pain during neuraxial anesthesia.
- Unable to provide informed valid consent.
- Other surgery (e.g., only cervical cerclage) or delivery mode (e.g., operative vaginal delivery).
- De nova general anesthetic.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 10/6/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Emily Sharpe, M.D. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available