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

NCT04369950 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-19-0951
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

cesarean delivery; c-section; chloroprocaine; lidocaine; morphine; post-operative pain; post-cesarean analgesia

Outcome Measures

Primary Outcomes (1)

• Total Amount of Opioid Used

  24 hours after epidural morphine administration

Secondary Outcomes (7)

• 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

  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

  4,8, 12 and 24 hours after epidural morphine administration

Study Arms (2)

2 percent Lidocaine with epinephrine and epidural morphine

ACTIVE COMPARATOR

Drug: 2% lidocaine with 1:200,000 epinephrine and epidural morphine

3 percent 2-Chloroprocaine and epidural morphine

EXPERIMENTAL

Drug: 3% 2-chloroprocaine and epidural morphine

Interventions

2% lidocaine with 1:200,000 epinephrine and epidural morphine DRUG

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.

2 percent Lidocaine with epinephrine and epidural morphine

3% 2-chloroprocaine and epidural morphine DRUG

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.

3 percent 2-Chloroprocaine and epidural morphine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant patients
• live singleton pregnancy

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Lee LO, Ramirez-Chapman AL, White DL, Zhang X, Lu M, Suresh MS. Postcesarean Analgesia With Epidural Morphine After Epidural 2-Chloroprocaine: A Randomized Noninferiority Trial. Anesth Analg. 2023 Jan 1;136(1):86-93. doi: 10.1213/ANE.0000000000006109. Epub 2022 Jun 3.

  PMID: 36534717 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Epinephrine; chloroprocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

No prior studies investigating the technique studied in order to calculate study size; wide interindividual differences in pain; physician administering epidural medications not blinded; originally intended to recruit 80, but due to recruitment challenges decided to modify recruitment goal to about 40 and classify this as an exploratory study

Results Point of Contact

• Title: Linden Lee, MD, Assistant Professor
• Organization: The University of Texas Health Science Center at Houston

Linden.O.Lee@uth.tmc.edu

(713) 500-6200

Study Officials

• Linden Lee, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: May 11, 2020
• Primary Completion: May 11, 2021
• Study Completion: July 11, 2021
• Last Updated: May 26, 2022
• Results First Posted: May 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)