Clinical trial NCT03926559: The Effect of Neuraxial Morphine (Duramorph) on Pain Control
Official title: The Effect of Neuraxial Morphine (Duramorph) on Pain Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Perineal Tear
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Postpartum pain
timeFrame: 24 hours postpartum
measure: Delayed postpartum pain
timeFrame: 48 hours postpartum
Secondary outcomes:
measure: Amount of narcotics used
timeFrame: 24 hours postpartum
measure: Amount of narcotics used
timeFrame: 48 hours postpartum
Other outcomes:
Locations:
city: N. Augusta
country: United States
facility: Augusta University Medical Center
state: South Carolina
Study officials:
References: