Vaginal Postpartum Pain Management Protocol Comparison

Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery

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.

Study Overview

• Status: Completed
• Conditions: Pain; Post Partum Depression; Breast Feeding; Opioid Use
• Intervention / Treatment: Drug: Ibuprofen 400Mg Tab; Drug: Ibuprofen 400 mg; Drug: Paracetamol 1000 Mg Oral Tablet; Drug: Paracetamol 1000 Mg Oral Tablet; Drug: MIR

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Yishai, Israel, 3009500
    • Rambam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed time interval group.; Patients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. 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).	Drug: Ibuprofen 400Mg Tab; The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.; Drug: Paracetamol 1000 Mg Oral Tablet; The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.; Other Names: Acetaminophen; Drug: Paracetamol 1000 Mg Oral Tablet; The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.; Other Names: Acetaminophen; Drug: MIR; 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).
Experimental: 'On-demand' group.; Patients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. 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).	Drug: Ibuprofen 400 mg; The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.; Drug: Paracetamol 1000 Mg Oral Tablet; The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.; Other Names: Acetaminophen; Drug: Paracetamol 1000 Mg Oral Tablet; The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.; Other Names: Acetaminophen; Drug: MIR; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS) score difference in the 24 first hours.	Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).	In the first 24 hours postpartum.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total analgesia requirements.	Total amount of analgesics use during 48 hours following a vaginal delivery.	Up to 48 hours postpartum.
Breastfeeding rate.	The rate of women who breastfeed their newborns and breastfeeding frequency.	Up to 48 hours postpartum.
Treatments side effects.	Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia.	Up to 48 hours postpartum.
Amount of additional analgesia requirements.	Total amount of additional analgesia up to maternal discharge.	Up to maternal discharge (5 days)
Visual analog scale (VAS) score difference up to maternal discharge.	Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).	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.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Gal Bachar, MD, Rambam Medical Health Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression, Postpartum; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: Rambam Health Care Center.

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: No
• Studies a U.S. FDA-regulated device product: No