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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen | Drug | IV Acetaminophen for pain control during procedure |
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| 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 |
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| John C Petrozza, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34548165 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: IV Acetaminophen/PO Placebo | 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. IV Acetaminophen: IV Acetaminophen for pain control during procedure Placebo PO Acetaminophen: Placebo PO Acetaminophen |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2019 |
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| PO Acetaminophen | Drug | PO Acetaminophen for pain control during procedure |
|
| Placebo IV Acetaminophen | Other | Placebo IV Acetaminophen |
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| Placebo PO Acetaminophen | Other | Placebo PO Acetaminophen |
|
| 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 |
| Group B: IV Placebo/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. PO Acetaminophen: PO Acetaminophen for pain control during procedure Placebo IV Acetaminophen: Placebo IV Acetaminophen |
| FG002 | Group C: IV Placebo/ PO Placebo | In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. Placebo IV Acetaminophen: Placebo IV Acetaminophen Placebo PO Acetaminophen: Placebo PO Acetaminophen |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: IV Acetaminophen/PO Placebo | 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. IV Acetaminophen: IV Acetaminophen for pain control during procedure Placebo PO Acetaminophen: Placebo PO Acetaminophen |
| BG001 | Group B: IV Placebo/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. PO Acetaminophen: PO Acetaminophen for pain control during procedure Placebo IV Acetaminophen: Placebo IV Acetaminophen |
| BG002 | Group C: IV Placebo / PO Placebo | In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. Placebo IV Acetaminophen: Placebo IV Acetaminophen Placebo PO Acetaminophen: Placebo PO Acetaminophen |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Ovarian reserve (anti-mullerian hormone) | Mean | Standard Deviation | ng/ml |
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| Number of Nulliparous Participants | Number | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Post-operative pain score - pre-operative pain score; 2 patients in group 3 had egg retrieval cancelled due to Coronavirus Disease (COVID); data could not be collected in these patients, yet their enrollment was included in an intention-to-treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Pain was measured pre-operatively and at 10 minutes post-procedure. |
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| Primary | 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. | 2 patients in group 3 had egg retrieval cancelled due to COVID; data could not be collected in these patients, yet their enrollment was included in an intention-to-treat analysis. | Posted | Mean | Standard Deviation | minutes | 0-6 hours post-procedure |
| |||||||||||||||||||||||||||||||||
| Secondary | Procedure Length | Duration of egg retrieval | 2 patients in group 3 had egg retrieval cancelled due to COVID; data could not be collected in these patients, yet their enrollment was included in an intention-to-treat analysis. | Posted | Mean | Standard Deviation | minutes | 0-2 hours |
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| Secondary | Postoperative Nausea and Vomiting | One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2 | 2 patients in group 3 had egg retrieval cancelled due to COVID; data could not be collected in these patients, yet their enrollment was included in an intention-to-treat analysis. | Posted | Count of Participants | Participants | 0-2 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | 2 patients in group 3 had egg retrieval cancelled due to COVID; data could not be collected in these patients, yet their enrollment was included in an intention-to-treat analysis. | Posted | Mean | Standard Deviation | oocytes | 0 days |
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| Secondary | 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. | 2 patients in group 3 had egg retrieval cancelled due to COVID; data could not be collected in these patients, yet their enrollment was included in an intention-to-treat analysis. | Posted | Count of Participants | Participants | During procedure and immediately post-operative in recovery room within 45 minutes |
|
12 weeks
Data was collected during procedural period, post-procedure, and during embryo development and 1st 12 weeks of pregnancy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: IV Acetaminophen/PO Placebo | 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. IV Acetaminophen: IV Acetaminophen for pain control during procedure Placebo PO Acetaminophen: Placebo PO Acetaminophen | 0 | 53 | 0 | 53 | 0 | 53 |
| EG001 | Group B: IV Placebo/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. PO Acetaminophen: PO Acetaminophen for pain control during procedure Placebo IV Acetaminophen: Placebo IV Acetaminophen | 0 | 54 | 0 | 54 | 0 | 54 |
| EG002 | Group C: IV Placebo/ PO Placebo | In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. Placebo IV Acetaminophen: Placebo IV Acetaminophen Placebo PO Acetaminophen: Placebo PO Acetaminophen | 0 | 54 | 0 | 54 | 0 | 54 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John C. Petrozza, M.D. | Massachusetts General Hospital | 617-726-8868 | jpetrozza@mgh.harvard.edu |
| Dec 1, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2019 | Dec 1, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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