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Completed

NCT Number: NCT04369950

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

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Key information

Conditions

Physiological Effect of Drugs Analgesics Analgesics, Opioid Central Nervous System Depressants Morphine Narcotics Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant patients
  • live singleton pregnancy

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Total Amount of Opioid Used

    Time frame: 24 hours after epidural morphine administration

Secondary outcomes

  1. Total Amount of Opioid Used

    Time frame: 12 hours after epidural morphine administration

  2. Total Amount of Opioid Used

    Time frame: 8 hours after epidural morphine administration

  3. Total Amount of Opioid Used

    Time frame: 4 hours after epidural morphine administration

  4. Pain as Measured by a 11 Point Verbal Scale

    Time frame: 4,8, 12 and 24 hours after epidural morphine administration

    scale ranges form 0-10, higher number indicating more pain

  5. Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale

    Time frame: 4,8, 12 and 24 hours after epidural morphine administration

    scale ranges from non,mild and moderate-severe

  6. Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale

    Time frame: 4,8, 12 and 24 hours after epidural morphine administration

    scale ranges from non,mild and moderate-severe

  7. Time Until First Opioid Request

    Time frame: Up to 48 hours after epidural morphine administration

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2020
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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