Infertility, FemalePhase 4NCT03073980
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval
A Phase 4 study testing IV Acetaminophen and PO Acetaminophen in people with Infertility, Female and Pain, Postoperative, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Pain, Postoperative
- What is being tested?
- IV Acetaminophen and PO Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 1 Dec 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- [ ] Patient is 18 years or over, undergoing oocyte retrieval. [ ] Patient is English-speaking.
Who cannot join
- [ ] 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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
- Being tested
- IV Acetaminophen, PO Acetaminophen, Placebo IV Acetaminophen, Placebo PO Acetaminophen
- Keywords
- in vitro fertilization, oocyte retrieval, acetaminophen, postoperative pain control
- Medical subject headings
- Infertility, Female, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
IV Acetaminophen for pain control during procedure
PO AcetaminophenDrug
PO Acetaminophen for pain control during procedure
Placebo IV AcetaminophenOther
Placebo IV Acetaminophen
Placebo PO AcetaminophenOther
Placebo PO Acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo IV Acetaminophen; Other: Placebo PO Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0-6 hours post-procedure
Secondary outcomes (4)
Procedure Length
Duration of egg retrieval
Measured: 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
Measured: 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.
Measured: 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.
Measured: During procedure and immediately post-operative in recovery room within 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Sep 2019
- Primary completion1 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John C Petrozza, Massachusetts General Hospital
- Investigators
- John C Petrozza, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073980
- Sponsor's protocol ID
- 2016P002465
- Status last verified
- May 2022
- First submitted
- 22 Feb 2017
- Last updated
- 26 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34548165
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03073980
- Acronym / sponsor ID
- 2016P002465
- Conditions
- Infertility, Female, Pain, Postoperative
- Keywords
- in vitro fertilization, oocyte retrieval, acetaminophen, postoperative pain control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Posted 20 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo | Experimental | Drug: IV Acetaminophen, Other: Placebo PO AcetaminophenIn 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 2: Intravenous (IV) placebo/oral (PO) acetaminophen | Active comparator | Drug: PO Acetaminophen, Other: Placebo IV AcetaminophenIn 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: Oral and intravenous Placebo / Standard of care | Placebo comparator | Other: Placebo IV Acetaminophen, Other: Placebo PO AcetaminophenIn the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- [ ] Patient is 18 years or over, undergoing oocyte retrieval. [ ] Patient is English-speaking.
Key exclusion criteria (3 listed)
- [ ] 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV AcetaminophenIV Acetaminophen for pain control during procedure | Drug | Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo |
| PO AcetaminophenPO Acetaminophen for pain control during procedure | Drug | Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen |
| Placebo IV AcetaminophenPlacebo IV Acetaminophen | Other | Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen, Group 3: Oral and intravenous Placebo / Standard of care |
| Placebo PO AcetaminophenPlacebo PO Acetaminophen | Other | Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo, Group 3: Oral and intravenous Placebo / Standard of care |
Primary outcome
Post-operative Pain Score Difference 10 Mins From Pre-operative
Time frame: Pain was measured pre-operatively and at 10 minutes post-procedure.
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
Time frame: 0-6 hours post-procedure
Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void.
4 secondary outcomes
Procedure Length
Time frame: 0-2 hours
Postoperative Nausea and Vomiting
Time frame: 0-2 days
Oocyte Yield
Time frame: 0 days
Rescue Medication Required
Time frame: During procedure and immediately post-operative in recovery room within 45 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34548165Sacha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C Petrozza, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Acetaminophen and PO Acetaminophen in people with Infertility, Female and Pain, Postoperative, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain Score Difference 10 Mins From Pre-operative (time frame: Pain was measured pre-operatively and at 10 minutes post-procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.