Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine

Phase 4

Completed

• Conditions: Central Nervous System Depressants; Physiological Effect of Drugs; Analgesics; Analgesics, Opioid; Narcotics; Morphine
• Interventions: Drug: 3% 2-chloroprocaine and epidural morphine

• Registration Number: NCT04369950
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Study Start: 2020-05-11
• Primary Completion: 2021-05-11
• Study Completion: 2021-07-11
• Status Verified: 2022-04
• Results First Submitted: 2022-04-28
• Results First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Results First Posted: 2022-05-26
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• pregnant patients
• live singleton pregnancy

Exclusion Criteria

• BMI >40
• obstructive sleep apnea
• drug abuse
• chronic pain
• chronic opioid use
• nonfunctioning epidural

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 percent 2-Chloroprocaine and epidural morphine	3% 2-chloroprocaine and epidural morphine	-

Primary Outcome Measures

Name	Time	Method
Total Amount of Opioid Used	24 hours after epidural morphine administration

Secondary Outcome Measures

Name	Time	Method
Total Amount of Opioid Used	4 hours after epidural morphine administration
Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale	4,8, 12 and 24 hours after epidural morphine administration	scale ranges from non,mild and moderate-severe
Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale	4,8, 12 and 24 hours after epidural morphine administration	scale ranges from non,mild and moderate-severe
Time Until First Opioid Request	Up to 48 hours after epidural morphine administration
Pain as Measured by a 11 Point Verbal Scale	4,8, 12 and 24 hours after epidural morphine administration	scale ranges form 0-10, higher number indicating more pain

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States