Phase 4
N=44
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
Physiological Effect of Drugs · Morphine · Analgesics · Analgesics, Opioid · Central Nervous System Depressants
Bottom Line
View on ClinicalTrials.gov: NCT04369950 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Total Amount of Opioid Used — 15; 0 milligrams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 2% lidocaine with 1:200,000 epinephrine and epidural morphine (Drug); 3% 2-chloroprocaine and epidural morphine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Amount of Opioid Used |
0; 0 | — |
| SECONDARY Total Amount of Opioid Used |
0; 0 | — |
| SECONDARY Total Amount of Opioid Used |
0; 0 | — |
| SECONDARY Total Amount of Opioid Used |
0; 0 | — |
| SECONDARY Pain as Measured by a 11 Point Verbal Scale |
0; 2.5; 0; 1; 3; 2 | — |
| SECONDARY Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale |
3; 1; 1; 2; 0; 0 | — |
| SECONDARY Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale |
7; 3; 6; 4; 4; 3 | — |
| SECONDARY Time Until First Opioid Request |
14.8; 24.7 | — |
Summary
The purpose of this study is to show that the effect of 3% 2-chloroprocaine prior to epidural morphine administration will be not inferior to the effect of epidural 2% lidocaine with 1:200,000 epinephrine on total opioid use for 24h
Eligibility Criteria
Inclusion Criteria
- pregnant patients
- live singleton pregnancy
Exclusion Criteria
- BMI >40
- obstructive sleep apnea
- drug abuse
- chronic pain
- chronic opioid use
- nonfunctioning epidural
Data sourced from ClinicalTrials.gov (NCT04369950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.