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Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

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ClinicalTrials.gov Identifier: NCT03105518
Recruitment Status : Completed
First Posted : April 10, 2017
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):

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

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)
Primary Purpose: Treatment
Official Title: Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
Actual Study Start Date : March 1, 2011
Primary Completion Date : October 30, 2011
Study Completion Date : October 30, 2011

Resource links provided by the National Library of Medicine

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 :
  1. Amount of Discomfort [ Time Frame: PACU admission, 15, 30 and 60 min postprocedure ]
    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 :
  1. 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. 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

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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
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Lawrence C Tsen, MD Brigham and Women's Hospital
More Information

Publications:
Responsible Party: Lawrence Ching Tsen, Vice Chair, Faculty Development and Education; Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03105518     History of Changes
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: December 5, 2017
Last Verified: November 2017
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:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Fentanyl
Oxycodone
Acetaminophen
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