Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

Study Overview
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Brief Summary
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The central objective of this study will be to evaluate the relationship between estrogen levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.

Detailed Description
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Subject will undergo standard clinical protocols for the entire oocyte stimulation cycle and all assisted reproductive procedure decisions and algorithms will be decided entirely independent of this study. The anesthetic and postoperative pain regimens will use the same agents and dose ranges used in clinical standard practice; however, the regimens will be standardized, so as to limit confounding variables. The study regimen for anesthesia will differ from the current, clinical standard by the mandated use of actual body weight (in current practice, actual, adjusted ideal, or ideal body weights are used), the use of fentanyl 1 mcg/kg IV (instead of 100 mcg for everyone), and the standardization of postoperative analgesia (noted below). The total amount of fentanyl, propofol, and postoperative drugs will be recorded. Postoperative analgesia will be standardized based on the subject's self reported verbal analogue score (VAS) and the timing of the report. The agents and timing used below differ from the current clinical standard by assessing VAS and responding with a certain regimen.

Official Title
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Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

Conditions
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Oocyte Retrieval, Postoperative Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) I to III health status (moderate systemic disease), Age between 18 and 50 yrs Undergoing oocyte retrieval with intravenous general anesthesia. Exclusion Criteria: Refuse or withdraw their consent Fail to adequately respond to IVF stimulations medications, and thus are not eligible for oocyte retrieval.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Interventional Model Description: Assessment of immediate and delayed postoperative pain
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Analgesia options<br>Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg. | Drug: Fentanyl<br>* 0.5, 1 mcg/kg<br>* Other names: Sublimaze;Drug: Acetaminophen<br>* Single + Oxycodone<br>* Other names: Tylenol;Drug: Oxycodone<br>* With Acetaminophen<br>* Other names: Percocet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Discomfort | Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. | PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Discomfort Following Discharge Until Embryo Transfer | Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. Visual Analogue Scale (VAS) scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer. | After 1 hrs but less than 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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assisted reproduction, postoperative pain, opioid