Recruitment

Recruitment Status
Active, not recruiting

Summary

Conditions
  • Oocyte Retrieval
  • Postoperative Pain
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Assessment of immediate and delayed postoperative painMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only males

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 i...

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.

Tracking Information

NCT #
NCT03105518
Collaborators
Not Provided
Investigators
Principal Investigator: Lawrence C Tsen, MD Brigham and Women's Hospital