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The Effect of Neuraxial Morphine (Duramorph) on Pain Control

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ClinicalTrials.gov Identifier: NCT03926559
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Augusta University

Brief Summary:
With the rise of the opioid epidemic, it is important for physicians to be more mindful of the amount of narcotic prescriptions that are being written every day. In the early postpartum period, pain and fatigue are the most common problems reported by women. Untreated pain has negative consequences on the amount of opioid narcotics used, postpartum depression, and the potential development of persistent chronic pain. While pain can interfere with a woman's ability to adequately take care of her newborn, narcotic abuse can lead to excessive maternal drowsiness and increased infant mortality in the new breastfeeding mother. The most common sources of pain after a vaginal delivery include breast engorgement, uterine contractions and perineal lacerations. Perineal lacerations are immediate postpartum complications of the vaginal birth process, defined as injury that involves the bulbocavernosum muscle complex (second degree), and may involve the anal sphincter complex (third degree) or the anal epithelium (fourth degree). Prevention of chronic and severe postpartum pain, especially after a cesarean delivery has been extensively studied, however, much paucity in research exists for the management of postpartum pain from perineal tears. Compared to patients with first degree tears or intact perineum, women with severe perineal lacerations (second degree or greater) have increased analgesic requirement up to the fifth postpartum day. . Epidural morphine has been accepted by anesthesiologists as treatment for acute pain. In obstetrics, 2-3 mg of epidural morphine was found to be sufficient to provide post-episiotomy analgesia. Neuraxial morphine has been used for analgesic management after a cesarean section, especially to reduce the amount of oral pain medications used in the first 24 hours, but limited data exists on the use of neuraxial morphine after a severe perineal laceration repair in the setting of a vaginal delivery. Niv et al (1994) studied the effect of epidural morphine and monitored its timing of administration in post-epiostomy pain onset. They noted that if epidural morphine is administered before the onset of pain in an episiotomy repair it is much more effective than if given after the onset. This study hopes to take the prior 1994 study a step further and incorporates it's data to investigate whether neuraxial morphine given after a severe perineal laceration repair mitigates postpartum pain.

Condition or disease Intervention/treatment Phase
Perineal Tear Drug: Morphine. Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect of Neuraxial Morphine (Duramorph) on Pain Control
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 21, 2021
Estimated Study Completion Date : May 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Duramorph (Morphine)
2mg of Neuraxial Morphine given through epidural once after the patient has delivered.
Drug: Morphine.
Pregnant patients with a perineal tear postpartum receive 2mg of morphine through their epidural. This will be a one time dose immediately postpartum.
Other Name: Duramorph

No Intervention: No intervention
Patient does not get any intervention.



Primary Outcome Measures :
  1. Postpartum pain [ Time Frame: 24 hours postpartum ]
    Pain is to be assessed using the Numeric Rating Scale. Scale ranges from 1(no pain) to 10 (most pain). This scale will be used at 24 hours.

  2. Delayed postpartum pain [ Time Frame: 48 hours postpartum ]
    Pain is to be assessed using the Numeric Rating Scale. Scale ranges from 1(no pain) to 10 (most pain). This scale will be used at 48 hours to assess for delayed postpartum pain.


Secondary Outcome Measures :
  1. Amount of narcotics used [ Time Frame: 24 hours postpartum ]
    The number of narcotics will be calculated using the medical record number of the participant and by noting the narcotics that the patients received in a 24 hour time frame. This is documented by the nursing staff.

  2. Amount of narcotics used [ Time Frame: 48 hours postpartum ]
    The number of narcotics will be calculated using the medical record number of the participant and by noting the narcotics that the patients received in a 48 hour time frame. This is documented by the nursing staff.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant females
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with a second degree, third degree, or fourth degree perineal tear identified in the immediate postpartum period.
  • Pregnant patients who received neuraxial anesthesia during their labor course
  • Women >18 yo

Exclusion Criteria:

  • Unwillingness to participate in the study
  • Allergy to morphine
  • Women with history of polysubstance abuse/narcotic abuse
  • Women <18 yo

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926559


Contacts
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Contact: Advaita Punjala-Patel, MD 9198092145 apunjala@augusta.edu
Contact: Linda Street, MD lstreet@augusta.edu

Locations
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United States, South Carolina
Augusta University Medical Center Recruiting
N. Augusta, South Carolina, United States, 29860
Contact: Advaita Punjala-Patel, MD    919-809-2145    apunjalapatel@augusta.edu   
Sponsors and Collaborators
Augusta University
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Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT03926559    
Other Study ID Numbers: 1313375-3
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents