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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial

Conditions
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Pain, Postoperative, Infertility, Female

Intervention / Treatment
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* Drug: IV Acetaminophen
* Drug: PO Acetaminophen
* Other: Placebo IV Acetaminophen
* Other: Placebo PO Acetaminophen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo<br>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<br>* IV Acetaminophen for pain control during procedure<br>Other: Placebo PO Acetaminophen<br>* Placebo PO Acetaminophen<br>|
| Active Comparator: Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen<br>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<br>* PO Acetaminophen for pain control during procedure<br>Other: Placebo IV Acetaminophen<br>* Placebo IV Acetaminophen<br>|
| Placebo Comparator: Group 3: Oral and intravenous Placebo / Standard of care<br>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<br>* Placebo IV Acetaminophen<br>Other: Placebo PO Acetaminophen<br>* Placebo PO Acetaminophen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in vitro fertilization, oocyte retrieval, acetaminophen, postoperative pain control