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

Primary Purpose

Infertility, Female, Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
PO Acetaminophen
Placebo IV Acetaminophen
Placebo PO Acetaminophen
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring in vitro fertilization, oocyte retrieval, acetaminophen, postoperative pain control

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

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

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

Group 3: Oral and intravenous Placebo / Standard of care

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Procedure Length
Duration of egg retrieval
Postoperative Nausea and Vomiting
One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2
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.
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.

Full Information

First Posted
February 22, 2017
Last Updated
May 4, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03073980
Brief Title
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval
Official Title
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Pain, Postoperative
Keywords
in vitro fertilization, oocyte retrieval, acetaminophen, postoperative pain control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 3: Oral and intravenous Placebo / Standard of care
Arm Type
Placebo Comparator
Arm Description
In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Intervention Description
IV Acetaminophen for pain control during procedure
Intervention Type
Drug
Intervention Name(s)
PO Acetaminophen
Intervention Description
PO Acetaminophen for pain control during procedure
Intervention Type
Other
Intervention Name(s)
Placebo IV Acetaminophen
Intervention Description
Placebo IV Acetaminophen
Intervention Type
Other
Intervention Name(s)
Placebo PO Acetaminophen
Intervention Description
Placebo PO Acetaminophen
Primary Outcome Measure Information:
Title
Post-operative Pain Score Difference 10 Mins From Pre-operative
Description
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.
Time Frame
Pain was measured pre-operatively and at 10 minutes post-procedure.
Title
Time to Discharge From the Post-operative Recovery Room
Description
Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void.
Time Frame
0-6 hours post-procedure
Secondary Outcome Measure Information:
Title
Procedure Length
Description
Duration of egg retrieval
Time Frame
0-2 hours
Title
Postoperative Nausea and Vomiting
Description
One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2
Time Frame
0-2 days
Title
Oocyte Yield
Description
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.
Time Frame
0 days
Title
Rescue Medication Required
Description
One or more doses of opiate pain medication given due to pain during the procedure or immediately post-operative in the recovery room.
Time Frame
During procedure and immediately post-operative in recovery room within 45 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Petrozza, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34548165
Citation
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.
Results Reference
derived

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

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