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

Analgesics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369950
• Other study ID #: HSC-MS-19-0951
• Status: Completed
• Phase: Phase 4
• Start date: May 11, 2020
• Est. completion date: July 11, 2021

Study information

• Verified date: April 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• pregnant patients
• live singleton pregnancy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Analgesics
• Analgesics, Opioid
• Central Nervous System Depressants
• Morphine
• Narcotics
• Physiological Effect of Drugs

Intervention

Drug:
• 2% lidocaine with 1:200,000 epinephrine and epidural morphine
Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
• 3% 2-chloroprocaine and epidural morphine
Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

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