Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

• ClinicalTrials.gov Identifier: NCT04653506
• Recruitment Status: Recruiting
• First Posted: December 4, 2020
• Last Update Posted: December 14, 2020
• Sponsor: Tel-Aviv Sourasky Medical Center
• Information provided by (Responsible Party): Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center

Study Description

Brief Summary:

The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Paracetamol 1000 mg; Drug: Ibuprofen 400 mg	Not Applicable

Detailed Description:

Postpartum pain is a common problem that leads to difficulties in basic daily activities, overuse of opioid medications, and even impaired breastfeeding ability. Non-opioid analgesia may play an essential role in reducing pain and improving the postpartum period including the ability to breastfeed and caring for the newborn.

This study will compare non-opioid treatment - 1000 mg Paracetamol versus 400 mg Ibuprofen in order to determine the optimal pain relief treatment in the early postpartum period that may decrease the use of opioid analgesia.

The investigators will evaluate the pain by the Numerical Rating Scale (NRS) index in the early postpartum period. The evaluation will conduct at 4-time points - while the women taking the pain relief (time 0), an hour later (time 1), 4, and 6 hours later (time 4 and time 6).

The investigators will compare the analgetic effect of each drug and evaluate the need for additional analgesia whether opioid or not.

Furthermore, the investigators will examine when women sought pain relief and whether pain relief contributes to the ability of Breastfeeding.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

• Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia (NRS <3)
• Pain Reliefs will be given in a double-blind mechanism, in closed envelopes
• The envelopes will contain Paracetamol 1000 mg or Ibuprofen 400 mg
• Women participating in the study will answer a questionnaire to characterize the pain while taking the pain relief (time 0), an hour later (time 1), 4 and 6 hours later (time 4 and time 6)

• Masking: Double (Participant, Care Provider)
• Masking Description: The primary investigator will be the only one to have the information about envelopes contain
• Primary Purpose: Treatment
• Official Title: Non - Opioid Treatments (Single Administration) for Pain During the Early Postpartum Period After Vaginal Delivery
• Actual Study Start Date: November 28, 2020
• Estimated Primary Completion Date: November 28, 2022
• Estimated Study Completion Date: November 28, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Paracetamol group; Women who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg)	Drug: Paracetamol 1000 mg; Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg
Experimental: Ibuprofen group; Women who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg)	Drug: Ibuprofen 400 mg; Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg

Outcome Measures

Primary Outcome Measures :

1. Pain relief after treatment with Paracetamol or Ibuprofen [ Time Frame: 6 hours after intervention ]
   After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The pain rating will be on the Numeric Rating Scale (NRS) that labeled from zero (no pain) to ten ((worst pain).

Secondary Outcome Measures :

1. Maximum pain location [ Time Frame: 6 hours after intervention ]
   After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The questionnaire will describe the maximal pain location area and the effectiveness of analgesic treatment in this area (by rating the pain on the NRS). The questionnaire will be at the time of taking the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6)

Other Outcome Measures:

1. Effect on breastfeeding [ Time Frame: 6 hours after intervention ]
   The participants will answer a questionnaire that will describe the effect of' pain relief on a woman's ability to breastfeed. The questionnaire will ask their desire to breastfeed before giving birth, did they really manage to breastfeed, and when they started breastfeeding. The investigator will describe if there is a correlation between pain relief and the ability to breastfeed.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Postpartum women
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Women between the ages of 18-50, who gave birth in a vaginal birth

Exclusion Criteria:

• Sensitivity to Paracetamol or Ibuprofen
• After cesarean section
• Received analgesia prior to study recruitment
• Perineal tears grade 3 \ 4
• Women with chronic pain, rheumatic disease, fibromyalgia, or trauma
• Women with a diagnosis or medication for anxiety or depression
• Dropout for women whose newborns needed respiratory support with intubation, cooling, prolonged hospitalization in NICU exceeding one week

Contacts and Locations

Contacts

Contact: Shai Ram, MD; 972 0506337159; shairam85@gmail.com

Contact: Sharon Maslovitz, MD; 972527360048; MASLOVITZ@gmail.com

Locations

Israel

Tel Aviv Medical Center; Recruiting

Tel Aviv, Israel, 6423906

Contact: shai ram, MD +972506337159 shairam85@gmail.com

Contact: MD

Principal Investigator: Sharon Maslovitz, MD

Principal Investigator: Shai Ram, MD

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

• Principal Investigator: shai ram, MD; Tel Aviv Medical Center

More Information

Publications:

Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204.

Fahey JO. Best Practices in Management of Postpartum Pain. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):126-136. doi: 10.1097/JPN.0000000000000241.

Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.

Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863. Erratum in: JAMA Netw Open. 2019 Aug 2;2(8):e1911235.

Deussen AR, Ashwood P, Martis R. Analgesia for relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2011 May 11;(5):CD004908. doi: 10.1002/14651858.CD004908.pub2. Review. Update in: Cochrane Database Syst Rev. 2020 Oct 20;10:CD004908.

Wuytack F, Smith V, Cleary BJ. Oral non-steroidal anti-inflammatory drugs (single dose) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2016 Jul 14;7:CD011352. doi: 10.1002/14651858.CD011352.pub2. Review. Update in: Cochrane Database Syst Rev. 2021 Jan 11;1:CD011352.

Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet. 1998 Feb;34(2):101-54. Review.

Chou D, Abalos E, Gyte GM, Gülmezoglu AM. Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD008407. doi: 10.1002/14651858.CD008407.pub2. Review.

• Responsible Party: Eli Sprecher, MD, director head of clinical trails department, principal investigator, clinical professor, Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT04653506
• Other Study ID Numbers: 0368-20-TLV
• First Posted: December 4, 2020
• Last Update Posted: December 14, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center:

Post Partum Pain, Pain Relief, Non-Opioids Analgesia

Additional relevant MeSH terms:

Acetaminophen; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antipyretics