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

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06114121

Enrollment

Registered

2023-11-02

Start date

2024-07-10

Completion date

2024-09-10

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

Keywords

erector spinae plane block

Brief summary

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

Interventions

PROCEDUREerector spinae plane block (ESP)

nerve block for abdominal pain. administered once immediately prior to spinal anesthetic standard of care.

DRUGDuramorph

100 micrograms (mcg) of morphine administered in the spinal medications one time.

DRUGRopivacaine

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.

DRUGBupivacaine Injection

Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
post-operative opioid analgesic medication	up to 24 hours	measurement (milligrams)

Secondary

Measure	Time frame	Description
change in post-operative pain medication by visual analog scale	baseline, up to 24 hours	Patient administered instrument to indicate pain on a level from 0 to10. (0: no pain. 10: worst imaginable pain)
number of minutes to first use of rescue medication	up to 24 hours	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.
obstetric quality of recovery scale	up to 24 hours	responses range from 0-10. zero is strongly agree, strongly disagree.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026