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

NCT ID: NCT03073980

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-12-01

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.

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.

Conditions

Infertility, Female; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

IV Acetaminophen

Intervention Type: DRUG

IV Acetaminophen for pain control during procedure

Placebo PO Acetaminophen

Intervention Type: OTHER

Placebo PO Acetaminophen

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.

Group Type: ACTIVE_COMPARATOR

PO Acetaminophen

Intervention Type: DRUG

PO Acetaminophen for pain control during procedure

Placebo IV Acetaminophen

Intervention Type: OTHER

Placebo IV Acetaminophen

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.

Group Type: PLACEBO_COMPARATOR

Placebo IV Acetaminophen

Intervention Type: OTHER

Placebo IV Acetaminophen

Placebo PO Acetaminophen

Intervention Type: OTHER

Placebo PO Acetaminophen

Interventions

IV Acetaminophen

IV Acetaminophen for pain control during procedure

Intervention Type: DRUG

PO Acetaminophen

PO Acetaminophen for pain control during procedure

Intervention Type: DRUG

Placebo IV Acetaminophen

Placebo IV Acetaminophen

Intervention Type: OTHER

Placebo PO Acetaminophen

Placebo PO Acetaminophen

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

John C Petrozza

Chief, Division of Reproductive Medicine and IVF, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John C Petrozza, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34548165 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2016P002465

Identifier Type: -

Identifier Source: org_study_id