The Effect of Neuraxial Morphine (Duramorph) on Pain Control

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.

Study Overview

• Status: Unknown
• Conditions: Perineal Tear
• Intervention / Treatment: Drug: Morphine.

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • N. Augusta, South Carolina, United States, 29860
      • Recruiting
      • Augusta University Medical Center
      • Contact: Advaita Punjala-Patel, MD; Phone Number: 919-809-2145; Email: apunjalapatel@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Duramorph
No Intervention: No intervention; Patient does not get any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of narcotics used	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.	24 hours postpartum
Amount of narcotics used	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.	48 hours postpartum

Collaborators and Investigators

• Sponsor: Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): May 21, 2021
• Study Completion (Anticipated): May 21, 2021

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 1313375-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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