Rectal Acetaminophen Use During Oocyte Retrievals to Reduce Post-Operative Opioid Utilization

Study Overview
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Brief Summary
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The primary aim of this study is to evaluate the administration of rectal acetaminophen to current and standard anesthesia and analgesia protocol in oocyte retrievals would reduce postoperative utilization of opioids (Tylenol with codeine) in fertility patients.

Detailed Description
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As the opioid epidemic shows no sign of abating, this national crisis deserves careful attention from all medical subspecialties. This includes reproductive endocrinology and infertility (REI), where opioids are primarily utilized for intraoperative and postoperative pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy, and laparoscopic myomectomy. The purpose of this study is to evaluate whether the administration of rectal acetaminophen in addition to the current, standard anesthesia and analgesia protocol in oocyte retrievals can help decrease utilization of prescribed opioid at home following oocyte retrieval. Rectal acetaminophen will be used rather than conventional IV acetaminophen because of the lack of access to IV acetaminophen at the study institution. Rectal acetaminophen is appealing because it is cheap, readily available in most medical centers and there is the potential for increased analgesic benefit due to the proximity to the vaginal and ovarian tissue, as well as the possible benefit from the partial avoidance of hepatic first-pass metabolism. This trial has the potential to provide practice-changing clinical information to the field of REI. The information gained can even translate to other ambulatory procedures and guide clinical practice. The investigators hypothesize that participants given rectal acetaminophen in addition to standard anesthesia/analgesia at the end of their oocyte retrieval will use less amount of prescribed Tylenol with codeine 3 days after discharge from the surgery center compared those receiving standard anesthesia/analgesia for oocyte retrieval.

Official Title
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Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients

Conditions
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Opioid Use

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Fentanyl
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any female patient undergoing oocyte retrieval by transvaginal ultrasound-guided ovarian puncture Exclusion Criteria: Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia. Patient with BMI greater than 40 Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval Patients with documented allergic reaction to acetaminophen Patient with contra-indication to the use of acetaminophen (liver disease) Patients with a history of past or current alcohol, drug or opioid abuse Patients with ulcerative colitis, Crohn's disease, or severe rectal hemorrhoids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 56 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl/propofol + acetaminophen<br>In addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval. | Drug: Acetaminophen<br>* Rectal acetaminophen will be administered to the intervention group at the conclusion of the oocyte retrieval.<br>* Other names: Tylenol;Drug: Fentanyl<br>* Weight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital<br>Drug: Propofol<br>* Weight-based IV Propofol as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital<br>|
| Active Comparator: Fentanyl/propofol only<br>Participants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol. | Drug: Fentanyl<br>* Weight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital<br>Drug: Propofol<br>* Weight-based IV Propofol as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized | The proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized 72 hours postoperatively will be assessed by telephone encounter. A total of 10 tablets of Tylenol #3 will be prescribed to each participant. Fewer Tylenol #3 used at the end of this time frame would indicate better outcome. | 72 hours following oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score in post-anesthesia care unit using the Visual Analog Scale | The Visual Analog Scale will be used to assess postoperative pain 1-hour after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome. | 1-hour after oocyte retrieval | 
| 24-hour pain score using the Visual Analog Scale | The Visual Analog Scale will be used to assess pain 24 hours after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome. | 24 hours after oocyte retrieval | 
| 48-hour pain score using the Visual Analog Scale measuring pain | The Visual Analog Scale will be used to assess pain 48 hours after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome. | 48 hours after oocyte retrieval | 
| 72-hour pain score using the Visual Analog Scale measuring pain | The Visual Analog Scale will be used to assess pain 72 hours after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome. | 72 hours after oocyte retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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egg retrieval, oocyte retrieval, opioid dependence, rectal acetaminophen, rectal tylenol, pain, opioid use, opioid abuse