Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 161
- Locations
- 1
- Primary Endpoint
- Post-operative Pain Score Difference 10 Mins From Pre-operative
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •[ ] Patient is 18 years or over, undergoing oocyte retrieval. [ ] Patient is English-speaking.
Exclusion Criteria
- •[ ] Allergy/hypersensitivity to acetaminophen or opiates. [ ] Any history of liver disease, history of alcohol depending, or renal impairment as reported in the electronic health record.
- •[ ] Any history chronic opiate use or chronic pain disorder reported in the electronic health record.
- •[ ] Weight less than 50kg as reported in the medical record.
Arms & Interventions
Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo
In the pre-operative suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.
Intervention: IV Acetaminophen (Drug)
Group 1: Intravenous (IV) acetaminophen/oral (PO) placebo
In the pre-operative suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.
Intervention: Placebo PO Acetaminophen (Other)
Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen
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.
Intervention: PO Acetaminophen (Drug)
Group 2: Intravenous (IV) placebo/oral (PO) acetaminophen
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.
Intervention: Placebo IV Acetaminophen (Other)
Group 3: Oral and intravenous Placebo / Standard of care
In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.
Intervention: Placebo IV Acetaminophen (Other)
Group 3: Oral and intravenous Placebo / Standard of care
In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.
Intervention: Placebo PO Acetaminophen (Other)
Outcomes
Primary Outcomes
Post-operative Pain Score Difference 10 Mins From Pre-operative
Time Frame: Pain was measured pre-operatively and at 10 minutes post-procedure.
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 to Discharge From the Post-operative Recovery Room
Time Frame: 0-6 hours post-procedure
Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void.
Secondary Outcomes
- Procedure Length(0-2 hours)
- Postoperative Nausea and Vomiting(0-2 days)
- Oocyte Yield(0 days)
- Rescue Medication Required(During procedure and immediately post-operative in recovery room within 45 minutes)
Investigators
John C Petrozza
Chief, Division of Reproductive Medicine and IVF, Principal Investigator, Clinical Professor
Massachusetts General Hospital