Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

Mass General Brigham

Status and phase: Active, not recruiting; Phase 4

Conditions: Postoperative Pain; Oocyte Retrieval

Treatments: Drug: Fentanyl; Drug: Oxycodone; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT03105518

2010-P-002310/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Analgesia options

Experimental group

Description:

Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.

Treatment:

Drug: Acetaminophen

Drug: Oxycodone

Drug: Fentanyl