Clinical trial NCT03105518: Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
Official title: Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oocyte Retrieval
Postoperative Pain
Keywords: assisted reproduction
postoperative pain
opioid
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assessment of immediate and delayed postoperative pain
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Amount of Discomfort
timeFrame: PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3
Secondary outcomes:
measure: Amount of Discomfort Following Discharge Until Embryo Transfer
timeFrame: After 1 hrs but less than 3 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Lawrence C Tsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harnett MJ, Bhavani-Shankar K, Datta S, Tsen LC. In vitro fertilization-induced alterations in coagulation and fibrinolysis as measured by thromboelastography. Anesth Analg. 2002 Oct;95(4):1063-6, table of contents. doi: 10.1097/00000539-200210000-00050.
citation: Bader AM, Datta S, Moller RA, Covino BG. Acute progesterone treatment has no effect on bupivacaine-induced conduction blockade in the isolated rabbit vagus nerve. Anesth Analg. 1990 Nov;71(5):545-8. doi: 10.1213/00000539-199011000-00016.
citation: Datta S, Lambert DH, Gregus J, Gissen AJ, Covino BG. Differential sensitivities of mammalian nerve fibers during pregnancy. Anesth Analg. 1983 Dec;62(12):1070-2.