Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

Study Overview
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Brief Summary
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The investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen

Detailed Description
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Oocyte retrieval is an outpatient procedure that is a routine surgical intervention in the process of assisted reproductive technologies and oocyte banking. The perioperative pain control is achieved with multidrug regimen including intraoperative opioid medication and perioperative administration of oral or intravenous acetaminophen. This medication is more commonly known as Tylenol. Intravenous formulation of this medication is several fold more expensive and the data for perioperative pain control is mixed on the equivalence of pain control with intravenous versus oral acetaminophen in other fields. Currently there is no accepted standard of care and the two formulations are used interchangeably depending on primary physician's preference. We are conducting an equivalence placebo controlled randomized clinical trial to assess the difference in efficacy of these two formulations

Official Title
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Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial

Conditions
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Postoperative Pain, IVF

Intervention / Treatment
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* Drug: acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Female, aged 18-45 Ability to take oral medication and be willing to adhere to the study intervention regimen Exclusion Criteria: Known clinically significant liver disfunction Known allergic reactions to components of acetaminophen such as angioedema, anaphylaxis or other Known current substance use disorder Chronic pain syndrome Weight less than 50 kg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral acetaminophen group<br>the subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval | Drug: acetaminophen<br>* compare the postoperative pain 1 hour and  24h post surgery<br>|
| Active Comparator: IV acetaminophen group<br>the subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively | Drug: acetaminophen<br>* compare the postoperative pain 1 hour and  24h post surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain control | To compare the efficacy of oral versus IV formulation of acetaminophen for controlling perioperative pain after oocyte retrieval procedure. To assess the pain level, Visual Analog Scale(VAS) score will be utilize with the minimum number 0 representing no pain and maximum number of 10 representing the highest imaginable pain level. | 24-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative recovery | To compare time from the end of procedure until discharge. This outcome is measured in minutes from the the time of entry to recovery room to the time when patient is leaving the facility | variable  1-3 hours | 

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