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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analgesia options | Experimental | Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | 0.5, 1 mcg/kg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence C Tsen, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12351295 | Result | Harnett MJ, Bhavani-Shankar K, Datta S, Tsen LC. In vitro fertilization-induced alterations in coagulation and fibrinolysis as measured by thromboelastography. Anesth Analg. 2002 Oct;95(4):1063-6, table of contents. doi: 10.1097/00000539-200210000-00050. | |
| 2221417 | Result | Bader AM, Datta S, Moller RA, Covino BG. Acute progesterone treatment has no effect on bupivacaine-induced conduction blockade in the isolated rabbit vagus nerve. Anesth Analg. 1990 Nov;71(5):545-8. doi: 10.1213/00000539-199011000-00016. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3 |
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 No Adverse Events in any subject |
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No limitations or caveats noted for this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Tsen, MD | Brigham and Women's Hospital/Harvard Medical School | 617.732.8216 | ltsen@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2010 | Aug 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
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Assessment of immediate and delayed postoperative pain
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| Acetaminophen | Drug | Single + Oxycodone |
|
|
| Oxycodone | Drug | With Acetaminophen |
|
|
| After 1 hrs but less than 3 days |
| 6650889 | Result | Datta S, Lambert DH, Gregus J, Gissen AJ, Covino BG. Differential sensitivities of mammalian nerve fibers during pregnancy. Anesth Analg. 1983 Dec;62(12):1070-2. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| 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. | All 100 parturients analyzed; divided into those who had less than, compared to more than 10 follicles on preoperative ultrasound image. | Posted | Mean | Standard Deviation | units on a scale | After 1 hrs but less than 3 days |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
|
| POD2; ≤10 Folli |
|
|
| POD2; >10 Folli |
|
|
| 0.2109 |
| 1 way Test, ChiSquare Approximation |
| 1.5654 |
| 2-Sided |
| Superiority |
| VAS at Post Operative Day 3; Follicles ≤10 vs. > 10 | Kruskal-Wallis | 0.9287 | 1-way Test, ChiSquare Approximation | 0.0080 | 2-Sided | Superiority |