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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073980
• Other study ID #: 2016P002465
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Pain, Postoperative

Intervention

Drug:
• IV Acetaminophen
IV Acetaminophen for pain control during procedure
• PO Acetaminophen
PO Acetaminophen for pain control during procedure

Other:
• Placebo IV Acetaminophen
Placebo IV Acetaminophen
• Placebo PO Acetaminophen
Placebo PO Acetaminophen

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pain was measured pre-operatively and at 10 minutes post-procedure.
Primary	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.	0-6 hours post-procedure
Secondary	Procedure Length	Duration of egg retrieval	0-2 hours
Secondary	Postoperative Nausea and Vomiting	One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2	0-2 days
Secondary	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.	0 days
Secondary	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.	During procedure and immediately post-operative in recovery room within 45 minutes