Clinical trial NCT04087317: Vaginal Postpartum Pain Management Protocol Comparison
Official title: Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Post Partum Depression
Opioid Use
Breast Feeding
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women following a vaginal delivery, with no exclusion criteria to participate in the study, will be addressed. After receiving all the information about the study, women who choose to participate will be consented.

All participants will be randomized to either scheduled analgesic administration (study group) or analgesic administration per women's request (control group) as accustomed at the investigator's unit.
Primary purpose: TREATMENT

Brief summary: Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.

Detailed description: More than two million women deliver vaginally every year in the United States (US). Along with the joy and happiness of having a new member in the family, women may suffer from cramping pain and lower abdomen discomfort following uterine involution; perineal pain due to perineal trauma or episiotomy; and nipple pain from breastfeeding or breast engorgement.

A stepwise approach using multimodal combination of medications can effectively provide an individualized pain management for women in their postpartum period. The first step includes non-opioid analgesics (as paracetamol and NSAIDs), step two adds milder opioids (as codeine, tramadol and oral morphine), and step three incorporates stronger opioids (as parenteral morphine).

In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.

Eligibility criteria: Inclusion Criteria:

1. Women following term vaginal delivery.

Exclusion Criteria:

1. Under Age 18 years or older than 45 years.
2. Women with chronic pain syndrome.
3. Women with relative or absolute contraindications for paracetamol or NSAIDs.

Primary outcomes:
measure: Visual analog scale (VAS) score difference in the 24 first hours.
timeFrame: In the first 24 hours postpartum.
Secondary outcomes:
measure: Amount of additional analgesia requirements.
timeFrame: Up to maternal discharge (5 days)
measure: Total analgesia requirements.
timeFrame: Up to 48 hours postpartum.
measure: Breastfeeding rate.
timeFrame: Up to 48 hours postpartum.
measure: Treatments side effects.
timeFrame: Up to 48 hours postpartum.
measure: Visual analog scale (VAS) score difference up to maternal discharge.
timeFrame: At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). up to 5 days.
Other outcomes:
Locations:
city: Ramat Yishai
country: Israel
facility: Rambam
Study officials:
affiliation: Rambam Medical Health Center
name: Gal Bachar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.