Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

Postoperative Pain Clinical Trial

Official title:

Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03105518
• Other study ID #: 2010-P-002310/1
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 1, 2011
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oocyte Retrieval
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Fentanyl
0.5, 1 mcg/kg
• Acetaminophen
Single + Oxycodone
• Oxycodone
With Acetaminophen

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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