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Perineal TearEarly Phase 1NCT03926559

The Effect of Neuraxial Morphine (Duramorph) on Pain Control

A Early Phase 1 study testing Morphine. in people with Perineal Tear, run by Augusta University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Perineal Tear
What is being tested?
Morphine.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteUnited States
Study dates
1 Apr 2019to 21 May 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Advaita Punjala-Patel, MD contact

9198092145

apunjala@augusta.edu

Linda Street, MD contact

lstreet@augusta.edu

United States1 site, 1 recruiting
  • Augusta University Medical Center

    North Augusta, South Carolina, 29860

    Advaita Punjala-Patel, MD, 919-809-2145, apunjalapatel@augusta.edu

    Recruiting

Other trials in United States

About this study

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
Being tested
Morphine.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Morphine.Drug

    Also called Duramorph

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

Study groups in NCT03926559
Study groupRoleWhat they receive
Duramorph (Morphine)Experimental2mg of Neuraxial Morphine given through epidural once after the patient has delivered.
Receives: Drug: Morphine.
No interventionNo interventionPatient does not get any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 hours postpartum

  2. 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.

    Measured: 48 hours postpartum

Secondary outcomes (2)
  1. 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.

    Measured: 24 hours postpartum

  2. 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.

    Measured: 48 hours postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2019
  2. Study start1 Apr 2019
  3. Primary completion21 May 2021 (estimated)
  4. Study completion21 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03926559
Sponsor's protocol ID
1313375-3
Status last verified
Jul 2020
First submitted
8 Jan 2019
Last updated
8 Jul 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Morphine. in people with Perineal Tear, run by Augusta University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Advaita Punjala-Patel, MD (9198092145, apunjala@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postpartum pain (time frame: 24 hours postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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