NCT03073980

Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval

Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Infertility, Female
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	IV Acetaminophen	IV Acetaminophen for pain control during procedure
DRUG	PO Acetaminophen	PO Acetaminophen for pain control during procedure
OTHER	Placebo IV Acetaminophen	Placebo IV Acetaminophen
OTHER	Placebo PO Acetaminophen	Placebo PO Acetaminophen

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-11-01
• Completion: 2020-12-01
• First posted: 2017-03-08
• Last updated: 2022-05-26
• Results posted: 2022-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study