Pain Management for Postoperative Pain

Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how estrogen levels might influence pain after egg retrieval for women undergoing in vitro fertilization (IVF). The researchers will explore various pain relief options, such as acetaminophen (Tylenol) and opioids, to determine which are most effective. Women scheduled for egg retrieval with general anesthesia and who have moderate health conditions are suitable candidates for this trial. Their participation could help refine pain management techniques for future IVF procedures. As a Phase 4 trial, this research aims to understand how FDA-approved treatments can benefit more patients, allowing participants to contribute to improved pain management strategies.

What is the safety track record for these treatments?

Research has shown that acetaminophen is generally safe in small amounts. However, taking more than 4,000 mg in a day can cause serious liver damage. This is crucial because acetaminophen often appears in other medicines, so avoid accidental overconsumption.

Studies have found that fentanyl is a strong painkiller when used correctly. It effectively relieves pain but can significantly slow breathing. Therefore, use it carefully and only under a doctor's supervision to prevent overdose.

Oxycodone is another pain reliever effective for moderate to severe pain. However, it can be addictive and may cause serious side effects like drowsiness, nausea, and, in severe cases, death from overdose.

The FDA has approved all three treatments for pain management, indicating they are considered safe when used as directed. Always follow dosing instructions and inform your healthcare provider immediately if any side effects occur.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about exploring the protocolized analgesia options for managing postoperative pain following oocyte retrieval because it offers a personalized approach based on the patient's level of discomfort. Unlike the typical standard of care that may involve a one-size-fits-all prescription of pain medications, this protocol uses a combination of acetaminophen, oxycodone, and fentanyl, administered according to the patient's specific needs. Additionally, it incorporates non-drug methods like heating pads to potentially reduce reliance on opioids, addressing concerns about opioid overuse and side effects. This tailored strategy could lead to more effective and safer pain management for patients undergoing assisted reproduction procedures.

What evidence suggests that this trial's treatments could be effective for pain following oocyte retrieval?

This trial will evaluate different analgesia options, including acetaminophen, fentanyl, and oxycodone, for managing pain. Studies have shown that acetaminophen effectively relieves short-term pain, especially when combined with other pain relievers. Many people experience pain relief for about four hours after taking it. Fentanyl, a strong pain reliever, works quickly and matches morphine's effectiveness for severe pain. Hospitals often use it for fast pain management. Oxycodone is another powerful option for severe pain, typically prescribed when other pain medicines are insufficient. All three treatments are well-regarded for managing pain and have a proven track record of effectiveness in various painful conditions.678910

Who Is on the Research Team?

LC

Lawrence C Tsen, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for women aged 18 to 50 who are having eggs collected for IVF under general anesthesia and are in generally good health (with mild to moderate medical conditions allowed). Women who don't respond well to IVF medications or do not consent can't join.

Inclusion Criteria

I am having my eggs collected under general anesthesia.
American Society of Anesthesiologists (ASA) I to III health status (moderate systemic disease)
I am between 18 and 50 years old.

Exclusion Criteria

I did not respond well to IVF medications and cannot have my eggs retrieved.
Refuse or withdraw their consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Oocyte Stimulation and Retrieval

Participants undergo standard clinical protocols for oocyte stimulation and retrieval

Varies based on individual protocols
Multiple visits for monitoring and retrieval

Postoperative Pain Management

Standardized analgesia based on VAS scores and timing, including use of heating pad, acetaminophen, percocet, and fentanyl

3 days
In-person monitoring and diary recording

Follow-up

Participants are monitored for discomfort and pain management effectiveness until embryo transfer

3 days
Diary returned at embryo transfer

What Are the Treatments Tested in This Trial?

Interventions

  • Acetaminophen
  • Fentanyl
  • Oxycodone

Trial Overview

The study looks at how estrogen levels relate to pain after egg retrieval. Participants may receive acetaminophen, fentanyl, or oxycodone as part of their pain management during the procedure.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Analgesia optionsExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33786837/

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