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Completed

NCT Number: NCT03073980

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IV acetaminophen

Drug

IV Acetaminophen for pain control during procedure

PO Acetaminophen

Drug

PO Acetaminophen for pain control during procedure

Placebo IV Acetaminophen

Other

Placebo IV Acetaminophen

Placebo PO Acetaminophen

Other

Placebo PO Acetaminophen

Primary outcomes

  1. 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.

  2. 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

  1. Procedure Length

    Time frame: 0-2 hours

    Duration of egg retrieval

  2. Postoperative Nausea and Vomiting

    Time frame: 0-2 days

    One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2

  3. Oocyte Yield

    Time frame: 0 days

    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.

  4. Rescue Medication Required

    Time frame: During procedure and immediately post-operative in recovery room within 45 minutes

    One or more doses of opiate pain medication given due to pain during the procedure or immediately post-operative in the recovery room.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2017
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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