The Effect of Neuraxial Morphine (Duramorph) on Pain Control

NCT03926559 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: 1313375-3
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Tear

Outcome Measures

Primary Outcomes (2)

• Postpartum pain

  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.

  24 hours postpartum

• Delayed postpartum pain

  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.

  48 hours postpartum

Secondary Outcomes (2)

• Amount of narcotics used

  24 hours postpartum

• Amount of narcotics used

  48 hours postpartum

Study Arms (2)

Duramorph (Morphine)

EXPERIMENTAL

2mg of Neuraxial Morphine given through epidural once after the patient has delivered.

Drug: Morphine.

No intervention

NO INTERVENTION

Patient does not get any intervention.

Interventions

Morphine. DRUG

Pregnant patients with a perineal tear postpartum receive 2mg of morphine through their epidural. This will be a one time dose immediately postpartum.

Also known as: Duramorph

Duramorph (Morphine)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University Medical Center

North Augusta, South Carolina, 29860, United States

RECRUITING

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Advaita Punjala-Patel, MD

CONTACT

9198092145; apunjala@augusta.edu

Linda Street, MD

CONTACT

lstreet@augusta.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: April 24, 2019
• Study Start: April 1, 2019
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)