The Effect of Neuraxial Morphine (Duramorph) on Pain Control

NCT ID: NCT03926559

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-05-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Duramorph (Morphine)

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

Group Type: EXPERIMENTAL

Morphine.

Intervention Type: DRUG

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

No intervention

Patient does not get any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Morphine.

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

Intervention Type: DRUG

Other Intervention Names

Duramorph

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Augusta University Medical Center

North Augusta, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Advaita Punjala-Patel, MD

Role: CONTACT

apunjala@augusta.edu

9198092145

Linda Street, MD

Role: CONTACT

lstreet@augusta.edu

Facility Contacts

Advaita Punjala-Patel, MD

Role: primary

apunjalapatel@augusta.edu

919-809-2145

Other Identifiers

1313375-3

Identifier Type: -

Identifier Source: org_study_id