Clinical trial NCT03073980: Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval
Official title: Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility, Female
Pain, Postoperative
Keywords: in vitro fertilization
oocyte retrieval
acetaminophen
postoperative pain control
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative Pain Score Difference 10 Mins From Pre-operative
timeFrame: Pain was measured pre-operatively and at 10 minutes post-procedure.
measure: Time to Discharge From the Post-operative Recovery Room
timeFrame: 0-6 hours post-procedure
Secondary outcomes:
measure: Procedure Length
timeFrame: 0-2 hours
measure: Postoperative Nausea and Vomiting
timeFrame: 0-2 days
measure: Oocyte Yield
timeFrame: 0 days
measure: Rescue Medication Required
timeFrame: During procedure and immediately post-operative in recovery room within 45 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: John C Petrozza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sacha CR, Mortimer R, Hariton E, James K, Hosseini A, Gray M, Xuan C, Hammer K, Lange A, Mahalingaiah S, Wang J, Petrozza JC. Assessing efficacy of intravenous acetaminophen for perioperative pain control for oocyte retrieval: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2022 Jan;117(1):133-141. doi: 10.1016/j.fertnstert.2021.08.046. Epub 2021 Sep 20.