In this research study we want to learn more about how effective certain medications are at reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the time between the retrieval and discharge from the hospital. We will compare three types of pre-operative medications: intravenous (IV) acetaminophen, oral (PO) acetaminophen, and placebo (no medication), which is the current typical care.
OBJECTIVE: To compare the efficacy of pre-operative IV acetaminophen, PO acetaminophen, versus placebo for adjunctive pain control in the setting of oocyte retrieval in an in vitro fertilization clinic setting. HYPOTHESIS: Our hypothesis is that patients receiving IV acetaminophen pre-operatively will have improved postoperative pain scores, lower overall opiate consumption, and shortened time to discharge from post analgesic recovery unit (PACU) or recovery than those receiving PO acetaminophen or placebo. Participants will be consented and enrolled in the study prior to their oocyte retrieval. The patient will then be randomized to one of three treatments: Group 1: In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed. Group 2: In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed. Group 3: In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. The patient and care team will be blinded to the treatment group. A member of the study staff will review participants' medical record to collect data regarding demographics, clinical history, cycle and pregnancy outcomes, up to 12 months following study completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
IV Acetaminophen for pain control during procedure
PO Acetaminophen for pain control during procedure
Placebo IV Acetaminophen
Massachusetts General Hospital
Boston, Massachusetts, United States
Post-operative Pain Score Difference 10 Mins From Pre-operative
Visual analog scale of pain, ranging from 0 (no pain) to 10 (worst pain imaginable) in whole numbers. The final score is the post-operative score minus the pre-operative score.
Time frame: Pain was measured pre-operatively and at 10 minutes post-procedure.
Time to Discharge From the Post-operative Recovery Room
Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void.
Time frame: 0-6 hours post-procedure
Procedure Length
Duration of egg retrieval
Time frame: 0-2 hours
Postoperative Nausea and Vomiting
One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2
Time frame: 0-2 days
Oocyte Yield
The number of oocytes retrieved from the patient's ovaries as part of an in vitro-fertilization treatment. This includes both immature and mature oocytes.
Time frame: 0 days
Rescue Medication Required
One or more doses of opiate pain medication given due to pain during the procedure or immediately post-operative in the recovery room.
Time frame: During procedure and immediately post-operative in recovery room within 45 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
161
Placebo PO Acetaminophen