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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):
Lawrence Ching Tsen, Brigham and Women's Hospital

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
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Analgesia Options
Hide Arm/Group Description

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

Period Title: Overall Study
Started 100
Completed 100
Not Completed 0
Arm/Group Title Analgesia Options
Hide Arm/Group Description

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

Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
35.54  (4.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
100
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Hispanic or Latino
5
   5.0%
Not Hispanic or Latino
95
  95.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 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%
1.Primary Outcome
Title Amount of Discomfort
Hide Description 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.
Time Frame PACU admission, 15, 30 and 60 min postprocedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
On PACU admission, subjects were divided into three groups based on the intensity of discomfort. A standardized postoperative analgesic regimen followed, based on VAS score and time (≤ or > than 30 min).
Arm/Group Title Analgesia Options
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
Time 0; ≤10 Follicles Number Analyzed 54 participants
1.53  (2.13)
Time 0; > 10 Follicles Number Analyzed 46 participants
3.25  (2.9)
Time 15; ≤10 Follicles Number Analyzed 54 participants
2.68  (2.19)
Time 15; >10 Follicles Number Analyzed 46 participants
3.61  (1.98)
Time 30; ≤10 Follicles Number Analyzed 54 participants
1.66  (1.40)
Time 30; >10 Follicles Number Analyzed 46 participants
2.93  (1.43)
Time 60; ≤10 Follicles Number Analyzed 54 participants
0.97  (1.16)
Time 60; >10 Follicles Number Analyzed 46 participants
2.19  (1.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Analgesia Options
Comments VAS at Time 0; Follicles ≤10 vs. > 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Method of Estimation Estimation Parameter 1 way test, chisquare approximation
Estimated Value 7.1880
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Analgesia Options
Comments VAS at Time 15; Follicles ≤10 vs. > 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Method of Estimation Estimation Parameter 1 way Test, ChiSquare Approximation
Estimated Value 3.6396
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Analgesia Options
Comments VAS at Time 30; Follicles ≤10 vs. > 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Method of Estimation Estimation Parameter 1 way Test, ChiSquare Approximation
Estimated Value 15.971
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Analgesia Options
Comments VAS at Time 60; Follicles ≤10 vs. > 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-way Test, ChiSquare Approximation
Estimated Value 16.0972
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Amount of Discomfort Following Discharge Until Embryo Transfer
Hide Description 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.
Time Frame After 1 hrs but less than 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 100 parturients analyzed; divided into those who had less than, compared to more than 10 follicles on preoperative ultrasound image.
Arm/Group Title Analgesia Options
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
POD1; ≤10 Folli Number Analyzed 54 participants
2.15  (1.72)
POD1; >10 Follicles Number Analyzed 46 participants
3.21  (1.87)
POD2; ≤10 Folli Number Analyzed 54 participants
1.28  (1.89)
POD2; >10 Folli Number Analyzed 46 participants
2.50  (2.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Analgesia Options
Comments VAS at POD 1; Follicles ≤10 vs. > 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0991
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-way Test, ChiSquare Approximation
Estimated Value 2.7205
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Analgesia Options
Comments VAS at POD2; Follicles ≤10 vs. > 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2109
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Method of Estimation Estimation Parameter 1 way Test, ChiSquare Approximation
Estimated Value 1.5654
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Analgesia Options
Comments VAS at POD3; Follicles ≤10 vs. > 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9287
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-way Test, ChiSquare Approximation
Estimated Value 0.0080
Estimation Comments [Not Specified]
Time Frame 3 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Analgesia Options
Hide Arm/Group Description

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

No Adverse Events in any subject

All-Cause Mortality
Analgesia Options
Affected / at Risk (%)
Total   0/100 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Analgesia Options
Affected / at Risk (%)
Total   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Analgesia Options
Affected / at Risk (%)
Total   0/100 (0.00%) 
No limitations or caveats noted for this study.
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
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