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

NCT03073980 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2016P002465
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility, Female; Pain, Postoperative

Keywords

in vitro fertilization; oocyte retrieval; acetaminophen; postoperative pain control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Procedure Length

  0-2 hours

• Postoperative Nausea and Vomiting

  0-2 days

• Oocyte Yield

  0 days

• Rescue Medication Required

  During procedure and immediately post-operative in recovery room within 45 minutes

Study Arms (3)

Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo

EXPERIMENTAL

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; Other: Placebo PO Acetaminophen

Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen

ACTIVE COMPARATOR

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; Other: Placebo IV Acetaminophen

Group 3: Oral and intravenous Placebo / Standard of care

PLACEBO COMPARATOR

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 IV Acetaminophen; Other: Placebo PO Acetaminophen

Interventions

IV Acetaminophen DRUG

IV Acetaminophen for pain control during procedure

Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo

PO Acetaminophen DRUG

PO Acetaminophen for pain control during procedure

Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen

Placebo IV Acetaminophen OTHER

Placebo IV Acetaminophen

Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen; Group 3: Oral and intravenous Placebo / Standard of care

Placebo PO Acetaminophen OTHER

Placebo PO Acetaminophen

Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo; Group 3: Oral and intravenous Placebo / Standard of care

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \[ \] 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 34548165 DERIVED

MeSH Terms

Conditions

Infertility, Female; Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: John C. Petrozza, M.D.
• Organization: Massachusetts General Hospital

jpetrozza@mgh.harvard.edu

617-726-8868

Study Officials

• John C Petrozza, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Reproductive Medicine and IVF, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 8, 2017
• Study Start: September 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 26, 2022
• Results First Posted: April 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)