170 Participants NeededMy employer runs this trial

Dexamethasone for Post Mastectomy Pain

OP
AR
Overseen ByAnne-Françoise Rousseau, MD, PhD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
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 tests whether dexamethasone, a drug commonly used during surgery to prevent nausea, affects long-term pain after a mastectomy. Researchers aim to determine if it reduces chronic pain or potentially worsens it. Participants will receive either dexamethasone or a placebo (a harmless substance) during surgery. Women who have undergone a mastectomy, with or without lymph node removal or immediate reconstruction, may qualify. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic corticosteroid therapy, you would not be eligible to participate.

What is the safety track record for dexamethasone?

Research has shown that dexamethasone is generally safe for people. Studies have found that using dexamethasone during surgery can reduce pain and the need for painkillers immediately afterward. For example, patients who received dexamethasone reported less pain and required fewer strong pain medications, like opioids, in the first few days after their operations.

One study found that dexamethasone did not affect long-term pain after breast removal surgery (mastectomy). Another study showed that dexamethasone reduced pain for up to 72 hours after surgery. Importantly, using dexamethasone has not been linked to serious side effects in these situations.

Dexamethasone is often used in surgeries to prevent nausea and vomiting, and its safety is well-documented. Overall, evidence suggests that dexamethasone is safe for use during surgeries, with no major side effects reported in the studies reviewed.12345

Why are researchers enthusiastic about this study treatment?

Most treatments for post-mastectomy pain focus on opioids or non-steroidal anti-inflammatory drugs (NSAIDs), which can have significant side effects like addiction or gastrointestinal issues. Dexamethasone is unique because it's a corticosteroid that reduces inflammation, thus potentially alleviating pain without the risk of addiction associated with opioids. Administered as a single intravenous dose at the time of anesthesia, it also targets postoperative nausea and vomiting. Researchers are excited because dexamethasone could offer a dual benefit—managing pain and reducing nausea—making recovery smoother and more comfortable for patients.

What evidence suggests that dexamethasone might be an effective treatment for post-mastectomy pain?

Research has shown that dexamethasone, a common steroid, can reduce pain after surgery. Studies have found that patients receiving dexamethasone reported less pain and required fewer painkillers post-operation. Specifically, one study noted that dexamethasone significantly lowered pain levels at various times after surgery. Additionally, dexamethasone reduces swelling, which might aid in long-term pain relief. In this trial, participants will receive either dexamethasone or a placebo to further investigate its effect on ongoing pain after a mastectomy, as its exact impact remains unclear.24567

Who Is on the Research Team?

OP

Oana Predescu, MD, PhD, MSc

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

TS

Thomas Schricker, MD, PhD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for women aged 18-75 having a mastectomy (with or without lymph node removal or reconstruction) who are generally healthy. It excludes those with chronic opioid use, recent breast surgery, pregnancy, breastfeeding, long-term steroid use, allergies to dexamethasone, men, and people with existing chronic pain.

Inclusion Criteria

I am a woman between 18 and 75 years old and can give my consent.
ASA physical status I-III
I am having a mastectomy, possibly with lymph node removal or immediate reconstruction.

Exclusion Criteria

Chronic opioid use
I have had breast surgery in the past three years.
Pregnancy or breastfeeding
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of dexamethasone 8 mg or placebo administered intravenously at induction of anesthesia

1 day
1 visit (in-person)

Follow-up

Participants are monitored for chronic post-mastectomy pain and other outcomes

3 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone

Trial Overview

The study compares giving dexamethasone (a steroid) versus normal saline during surgery to see if it affects the risk of developing long-term pain after a mastectomy. Participants are randomly assigned to one group or the other and neither they nor their doctors know which treatment they're getting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: DexamethasoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials
476
Recruited
170,000+

Citations

Preoperative dexamethasone reduces postoperative pain ...

Our results suggest that preoperative dexamethasone at 8 mg ameliorates nausea, vomiting, pain and reduces the analgesic and antiemetic requirements of women ...

Comparison of Dexamethasone Doses on Persistent ...

This study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy operations. Half of the participants will receive 0.1 mg/kg ...

What is the impact of dexamethasone on postoperative pain in ...

Patients receiving dexamethasone had reduced pain scores, postoperative opioid requirements and longer time to first analgesia.

Impact of perioperative dexamethasone on postoperative ...

Patients treated with dexamethasone experienced less postoperative pain, required less postoperative opioids, had longer time to first analgesic dose, needed ...

Effect of Dexamethasone in Postoperative Symptoms After ...

The purpose of this study was to evaluate the efficacy of dexamethasone treatment for reducing pain and PONV as well as analgesic and antiemetic requirements in ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31977520/

Dexamethasone Dose and Early Postoperative Recovery ...

Conclusions: The authors found no evidence of 24 mg versus 8 mg of dexamethasone affecting the primary outcome regarding immediate recovery after mastectomy.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26263077/

Perioperative Dexamethasone and the Development of ...

Conclusions: Perioperative dexamethasone is not associated with a reduction in the incidence and/or severity of chronic postmastectomy pain. In addition, we did ...