Oocyte Retrieval, Postoperative Pain
Conditions
Keywords
assisted reproduction, postoperative pain, opioid
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.
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.
Interventions
DRUGFentanyl
0.5, 1 mcg/kg
DRUGAcetaminophen
Single + Oxycodone
DRUGOxycodone
With Acetaminophen
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Assessment of immediate and delayed postoperative pain
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Discomfort | 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
| Measure | Time frame | Description |
|---|---|---|
| Amount of Discomfort Following Discharge Until Embryo Transfer | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLawrence C Tsen, MD
Brigham and Women's Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Analgesia Options |
|---|---|
| Age, Continuous | 35.54 years STANDARD_DEVIATION 4.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Amount of Discomfort
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, 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Analgesia Options | Amount of Discomfort | Time 0; ≤10 Follicles | 1.53 units on a scale | Standard Deviation 2.13 |
| Analgesia Options | Amount of Discomfort | Time 30; >10 Follicles | 2.93 units on a scale | Standard Deviation 1.43 |
| Analgesia Options | Amount of Discomfort | Time 60; ≤10 Follicles | 0.97 units on a scale | Standard Deviation 1.16 |
| Analgesia Options | Amount of Discomfort | Time 60; >10 Follicles | 2.19 units on a scale | Standard Deviation 1.55 |
| Analgesia Options | Amount of Discomfort | Time 0; > 10 Follicles | 3.25 units on a scale | Standard Deviation 2.9 |
| Analgesia Options | Amount of Discomfort | Time 15; ≤10 Follicles | 2.68 units on a scale | Standard Deviation 2.19 |
| Analgesia Options | Amount of Discomfort | Time 15; >10 Follicles | 3.61 units on a scale | Standard Deviation 1.98 |
| Analgesia Options | Amount of Discomfort | Time 30; ≤10 Follicles | 1.66 units on a scale | Standard Deviation 1.4 |
| Analgesia Options | Amount of Discomfort | Time POD 3; ≤ 10 Follicles | 1.44 units on a scale | Standard Deviation 1.15 |
| Analgesia Options | Amount of Discomfort | Time POD 3; > 10 Follicles | 1.64 units on a scale | Standard Deviation 1.82 |
Comparison: VAS at Time 0; Follicles ≤10 vs. \> 10p-value: 0.007Kruskal-Wallis
Comparison: VAS at Time 15; Follicles ≤10 vs. \> 10p-value: 0.056Kruskal-Wallis
Comparison: VAS at Time 30; Follicles ≤10 vs. \> 10p-value: <0.0001Kruskal-Wallis
Comparison: VAS at Time 60; Follicles ≤10 vs. \> 10p-value: <0.0001Kruskal-Wallis
Secondary
Amount of Discomfort Following Discharge Until Embryo Transfer
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Analgesia Options | Amount of Discomfort Following Discharge Until Embryo Transfer | POD1; ≤10 Folli | 2.15 units on a scale | Standard Deviation 1.72 |
| Analgesia Options | Amount of Discomfort Following Discharge Until Embryo Transfer | POD1; >10 Follicles | 3.21 units on a scale | Standard Deviation 1.87 |
| Analgesia Options | Amount of Discomfort Following Discharge Until Embryo Transfer | POD2; ≤10 Folli | 1.28 units on a scale | Standard Deviation 1.89 |
| Analgesia Options | Amount of Discomfort Following Discharge Until Embryo Transfer | POD2; >10 Folli | 2.50 units on a scale | Standard Deviation 2.35 |
Comparison: VAS at Post Operative Day 1; Follicles ≤10 vs. \> 10p-value: 0.0991Kruskal-Wallis
Comparison: VAS at Post Operative Day 2; Follicles ≤10 vs. \> 10p-value: 0.2109Kruskal-Wallis
Comparison: VAS at Post Operative Day 3; Follicles ≤10 vs. \> 10p-value: 0.9287Kruskal-Wallis