Intrathecal Morphine vs. Intrathecal Morphine and Regional Anesthesia After Cesarean Section.

Post-operative Pain Clinical Trial

Official title:

Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06114121
• Other study ID #: 20230857
• Status: Suspended
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

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