Trial Outcomes & Findings for Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction (NCT NCT03105518)

Last Updated: 2022-08-03

Results Overview

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.

Recruitment status

UNKNOWN

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3

Results posted on

2022-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Analgesia Options n=100 Participants 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
Age, Continuous	35.54 years STANDARD_DEVIATION 4.61 • n=99 Participants
Sex: Female, Male Female	100 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	5 Participants n=99 Participants
Race (NIH/OMB) White	90 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3

Population: 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).

Outcome measures

Outcome measures
Measure	Analgesia Options n=100 Participants 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
Amount of Discomfort Time 0; ≤10 Follicles	1.53 units on a scale Standard Deviation 2.13
Amount of Discomfort Time 0; > 10 Follicles	3.25 units on a scale Standard Deviation 2.9
Amount of Discomfort Time 15; ≤10 Follicles	2.68 units on a scale Standard Deviation 2.19
Amount of Discomfort Time 15; >10 Follicles	3.61 units on a scale Standard Deviation 1.98
Amount of Discomfort Time 30; ≤10 Follicles	1.66 units on a scale Standard Deviation 1.40
Amount of Discomfort Time 30; >10 Follicles	2.93 units on a scale Standard Deviation 1.43
Amount of Discomfort Time 60; ≤10 Follicles	0.97 units on a scale Standard Deviation 1.16
Amount of Discomfort Time 60; >10 Follicles	2.19 units on a scale Standard Deviation 1.55
Amount of Discomfort Time POD 3; ≤ 10 Follicles	1.44 units on a scale Standard Deviation 1.15
Amount of Discomfort Time POD 3; > 10 Follicles	1.64 units on a scale Standard Deviation 1.82

SECONDARY outcome

Timeframe: After 1 hrs but less than 3 days

Population: All 100 parturients analyzed; divided into those who had less than, compared to more than 10 follicles on preoperative ultrasound image.

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.

Outcome measures

Outcome measures
Measure	Analgesia Options n=100 Participants 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
Amount of Discomfort Following Discharge Until Embryo Transfer POD1; ≤10 Folli	2.15 units on a scale Standard Deviation 1.72
Amount of Discomfort Following Discharge Until Embryo Transfer POD1; >10 Follicles	3.21 units on a scale Standard Deviation 1.87
Amount of Discomfort Following Discharge Until Embryo Transfer POD2; ≤10 Folli	1.28 units on a scale Standard Deviation 1.89
Amount of Discomfort Following Discharge Until Embryo Transfer POD2; >10 Folli	2.50 units on a scale Standard Deviation 2.35

Adverse Events

Analgesia Options

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lawrence Tsen, MD

Brigham and Women's Hospital/Harvard Medical School

Phone: 617.732.8216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place