Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
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|ClinicalTrials.gov Identifier: NCT03105518|
Recruitment Status : Active, not recruiting
First Posted : April 10, 2017
Results First Posted : December 5, 2017
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oocyte Retrieval Postoperative Pain||Drug: Fentanyl Drug: Acetaminophen Drug: Oxycodone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Assessment of immediate and delayed postoperative pain|
|Masking:||None (Open Label)|
|Official Title:||Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction|
|Actual Study Start Date :||March 1, 2011|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||August 30, 2020|
Experimental: Analgesia options
Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.
0.5, 1 mcg/kg
Other Name: Sublimaze
Single + Oxycodone
Other Name: Tylenol
Other Name: Percocet
- Amount of Discomfort [ Time Frame: PACU 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.
- Amount of Discomfort Following Discharge Until Embryo Transfer [ Time Frame: After 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105518
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Lawrence C Tsen, MD||Brigham and Women's Hospital|