Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval

Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial

In this research study we want to learn more about how effective certain medications are at reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the time between the retrieval and discharge from the hospital. We will compare three types of pre-operative medications: intravenous (IV) acetaminophen, oral (PO) acetaminophen, and placebo (no medication), which is the current typical care.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Infertility, Female
• Intervention / Treatment: Drug: IV Acetaminophen; Other: Placebo PO Acetaminophen; Drug: PO Acetaminophen; Other: Placebo IV Acetaminophen

Detailed Description

OBJECTIVE: To compare the efficacy of pre-operative IV acetaminophen, PO acetaminophen, versus placebo for adjunctive pain control in the setting of oocyte retrieval in an in vitro fertilization clinic setting.

HYPOTHESIS: Our hypothesis is that patients receiving IV acetaminophen pre-operatively will have improved postoperative pain scores, lower overall opiate consumption, and shortened time to discharge from post analgesic recovery unit (PACU) or recovery than those receiving PO acetaminophen or placebo.

Participants will be consented and enrolled in the study prior to their oocyte retrieval. The patient will then be randomized to one of three treatments:

Group 1: In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.

Group 2: In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed.

Group 3:

In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.

The patient and care team will be blinded to the treatment group.

A member of the study staff will review participants' medical record to collect data regarding demographics, clinical history, cycle and pregnancy outcomes, up to 12 months following study completion.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

[ ] Patient is 18 years or over, undergoing oocyte retrieval. [ ] Patient is English-speaking.

Exclusion Criteria:

[ ] Allergy/hypersensitivity to acetaminophen or opiates. [ ] Any history of liver disease, history of alcohol depending, or renal impairment as reported in the electronic health record.

[ ] Any history chronic opiate use or chronic pain disorder reported in the electronic health record.

[ ] Weight less than 50kg as reported in the medical record.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo; In the pre-operative suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.	Drug: IV Acetaminophen; IV Acetaminophen for pain control during procedure; Other: Placebo PO Acetaminophen; Placebo PO Acetaminophen
Active Comparator: Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen; In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed.	Drug: PO Acetaminophen; PO Acetaminophen for pain control during procedure; Other: Placebo IV Acetaminophen; Placebo IV Acetaminophen
Placebo Comparator: Group 3: Oral and intravenous Placebo / Standard of care; In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.	Other: Placebo PO Acetaminophen; Placebo PO Acetaminophen; Other: Placebo IV Acetaminophen; Placebo IV Acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain Score Difference 10 Mins From Pre-operative	Visual analog scale of pain, ranging from 0 (no pain) to 10 (worst pain imaginable) in whole numbers. The final score is the post-operative score minus the pre-operative score.	Pain was measured pre-operatively and at 10 minutes post-procedure.
Time to Discharge From the Post-operative Recovery Room	Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void.	0-6 hours post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Length	Duration of egg retrieval	0-2 hours
Postoperative Nausea and Vomiting	One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2	0-2 days
Oocyte Yield	The number of oocytes retrieved from the patient's ovaries as part of an in vitro-fertilization treatment. This includes both immature and mature oocytes.	0 days
Rescue Medication Required	One or more doses of opiate pain medication given due to pain during the procedure or immediately post-operative in the recovery room.	During procedure and immediately post-operative in recovery room within 45 minutes

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: John C Petrozza, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Sacha CR, Mortimer R, Hariton E, James K, Hosseini A, Gray M, Xuan C, Hammer K, Lange A, Mahalingaiah S, Wang J, Petrozza JC. Assessing efficacy of intravenous acetaminophen for perioperative pain control for oocyte retrieval: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2022 Jan;117(1):133-141. doi: 10.1016/j.fertnstert.2021.08.046. Epub 2021 Sep 20.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: acetaminophen; oocyte retrieval; in vitro fertilization; postoperative pain control
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Infertility; Infertility, Female; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2016P002465

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