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

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

Study Overview

• Status: Completed
• Conditions: Morphine; Analgesics, Opioid; Central Nervous System Depressants; Analgesics; Narcotics; Physiological Effect of Drugs
• Intervention / Treatment: Drug: 2% lidocaine with 1:200,000 epinephrine and epidural morphine; Drug: 3% 2-chloroprocaine and epidural morphine

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant patients
• live singleton pregnancy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2 percent Lidocaine with epinephrine and epidural morphine	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.
Experimental: 3 percent 2-Chloroprocaine and epidural morphine	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Amount of Opioid Used	24 hours after epidural morphine administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Amount of Opioid Used		12 hours after epidural morphine administration
Total Amount of Opioid Used		8 hours after epidural morphine administration
Total Amount of Opioid Used		4 hours after epidural morphine administration
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
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
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
Time Until First Opioid Request		Up to 48 hours after epidural morphine administration

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Linden Lee, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): July 11, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: lidocaine; morphine; post-operative pain; cesarean delivery; chloroprocaine; c-section; post-cesarean analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Morphine; Epinephrine; Chloroprocaine
• Other Study ID Numbers: HSC-MS-19-0951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No