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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 Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Oocyte Retrieval
Postoperative Pain
Interventions: Drug: Fentanyl
Drug: Acetaminophen
Drug: Oxycodone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Fentanyl: 0.5, 1 mcg/kg

Acetaminophen: Single + Oxycodone

Oxycodone: With Acetaminophen


Participant Flow:   Overall Study
    Analgesia Options
STARTED   100 
COMPLETED   100 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Fentanyl: 0.5, 1 mcg/kg

Acetaminophen: Single + Oxycodone

Oxycodone: With Acetaminophen


Baseline Measures
   Analgesia Options 
Overall Participants Analyzed 
[Units: Participants]
 100 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.54  (4.61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      100 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      5   5.0% 
Not Hispanic or Latino      95  95.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      5   5.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      5   5.0% 
White      90  90.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

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

2.  Secondary:   Amount of Discomfort Following Discharge Until Embryo Transfer   [ Time Frame: After 1 hrs but less than 3 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No limitations or caveats noted for this study.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lawrence Tsen, MD
Organization: Brigham and Women's Hospital/Harvard Medical School
phone: 617.732.8216
e-mail: ltsen@bwh.harvard.edu


Publications of Results:

Responsible Party: Lawrence Ching Tsen, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03105518     History of Changes
Other Study ID Numbers: 2010-P-002310/1
First Submitted: October 5, 2014
First Posted: April 10, 2017
Results First Submitted: April 16, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017