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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT06114121
Other study ID # 20230857
Secondary ID
Status Suspended
Phase Phase 4
First received
Last updated
Start date July 10, 2024
Est. completion date September 10, 2024

Study information

Verified date May 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to optimize post-operative analgesia and improve patient satisfaction while reducing total opioid consumption after cesarean section


Recruitment information / eligibility

Status Suspended
Enrollment 100
Est. completion date September 10, 2024
Est. primary completion date September 10, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion criteria: - Able to consent - BMI<35 Exclusion Criteria: - Adults unable to consent - BMI>35 - Individuals <18 years of age at time of admission - Individuals taking anticoagulant medications - Significant co-morbid disease of pregnancy (including: gestational diabetes and significant abnormal placentation) - Pre-existing chronic pain or pain disorder diagnosis - Conversion from neuraxial to general anesthesia - Prisoners

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
erector spinae plane block (ESP)
nerve block for abdominal pain. administered once immediately prior to spinal anesthetic standard of care.
Drug:
Duramorph
100 micrograms (mcg) of morphine administered in the spinal medications one time.
Ropivacaine
Ropivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose.
Bupivacaine Injection
Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary post-operative opioid analgesic medication measurement (milligrams) up to 24 hours
Secondary change in post-operative pain medication by visual analog scale Patient administered instrument to indicate pain on a level from 0 to10. (0: no pain. 10: worst imaginable pain) baseline, up to 24 hours
Secondary number of minutes to first use of rescue medication the number of minutes calculated using the kaplan-meier. Calculated using the number of patients that did not need the rescue analgesic at the start of each day post-surgery, and the number of patients who needed the rescue analgesic. up to 24 hours
Secondary obstetric quality of recovery scale responses range from 0-10. zero is strongly agree, strongly disagree. up to 24 hours
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