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

Sponsor:

Information provided by (Responsible Party):

Lawrence Ching Tsen, Brigham and Women's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Oocyte Retrieval Postoperative Pain	Drug: Fentanyl Drug: Acetaminophen Drug: Oxycodone	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Intervention Model Description:	Assessment of immediate and delayed postoperative pain
Masking:	None (Open Label)
Primary Purpose:	Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone Acetaminophen Fentanyl

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Fentanyl 0.5, 1 mcg/kg Other Name: Sublimaze Drug: Acetaminophen Single + Oxycodone Other Name: Tylenol Drug: Oxycodone With Acetaminophen Other Name: Percocet

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

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Principal Investigator:	Lawrence C Tsen, MD	Brigham and Women's Hospital

Study Documents (Full-Text)

Documents provided by Lawrence Ching Tsen, Brigham and Women's Hospital:

Study Protocol and Statistical Analysis Plan [PDF] September 13, 2010

More Information

Publications of Results:

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.

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.

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.

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Responsible Party:	Lawrence Ching Tsen, Vice Chair, Faculty Development and Education; Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT03105518
Other Study ID Numbers:	2010-P-002310/1
First Posted:	April 10, 2017 Key Record Dates
Results First Posted:	December 5, 2017
Last Update Posted:	January 18, 2020
Last Verified:	January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Lawrence Ching Tsen, Brigham and Women's Hospital:


assisted reproduction postoperative pain opioid

Additional relevant MeSH terms:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Acetaminophen Fentanyl Oxycodone Analgesics, Opioid Narcotics Central Nervous System Depressants	Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Non-Narcotic Antipyretics

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