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Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

Phase 4
Conditions
Postoperative Pain
Oocyte Retrieval
Interventions
Registration Number
NCT03105518
Lead Sponsor
Brigham and Women's Hospital
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
100
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Analgesia optionsFentanylProtocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.
Analgesia optionsAcetaminophenProtocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.
Analgesia optionsOxycodoneProtocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.
Primary Outcome Measures
NameTimeMethod
Amount of DiscomfortPACU admission, 15, 30 and 60 min postprocedure, postoperative day 3

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.

Secondary Outcome Measures
NameTimeMethod
Amount of Discomfort Following Discharge Until Embryo TransferAfter 1 hrs but less than 3 days

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.

Trial Locations

Locations (1)

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

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