Dexamethasone for Chronic Pain After Thoracic Surgery

Overseen By Nadia Godin, nurse

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Maisonneuve-Rosemont Hospital

Must not be taking: Cortisone, Dexamethasone, Opioids

Disqualifiers: Contra-indication to epidural, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dexamethasone, a strong anti-inflammatory drug, can reduce long-term pain after chest surgery. Researchers believe that administering dexamethasone before surgery might help by calming inflammation, which could cause this pain. The trial includes two groups: one will receive dexamethasone, and the other will receive a placebo (a harmless, inactive substance). It seeks participants undergoing planned chest surgery with a specific type of pain management who are not already on similar medications or long-term painkillers.

As an unphased trial, this study offers a unique opportunity to contribute to understanding pain management after surgery.

Will I have to stop taking my current medications?

If you are currently taking cortisone, dexamethasone, or chronic opioid medications, you cannot participate in this trial. The protocol does not specify about other medications.

Is there any evidence suggesting that dexamethasone is likely to be safe for humans?

Studies have shown that a single dose of dexamethasone is generally safe for people. Dexamethasone, a powerful drug, reduces inflammation. Research indicates that it can effectively lessen pain after surgeries such as tummy tucks and heart surgeries.

The PADDI researchers provided evidence that dexamethasone is not only effective but also safe for reducing long-term pain after surgery. Most people do not experience serious side effects from just one dose.

In summary, dexamethasone is well-tolerated when administered in a controlled setting, such as before surgery, to help manage pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Dexamethasone is unique because it offers a potential new approach to managing chronic pain after thoracic surgery. Unlike typical treatments, such as opioids or nonsteroidal anti-inflammatory drugs (NSAIDs), which often focus on pain relief with potential side effects or dependency issues, dexamethasone works as a corticosteroid to reduce inflammation at the source. This anti-inflammatory action could mean fewer side effects and a more targeted pain management strategy. Researchers are excited because dexamethasone might provide effective pain relief with a single pre-incision dose, potentially improving recovery and reducing the need for other pain medications.

What evidence suggests that dexamethasone might be an effective treatment for post thoracotomy pain syndrome?

Research has shown that a single dose of dexamethasone can greatly reduce pain soon after surgery and lessen the need for painkillers like opioids. For example, studies indicate that dexamethasone helps manage pain after surgeries such as thoracotomy by reducing swelling. Evidence supports its safety and effectiveness in lowering long-term pain after surgery. In this trial, participants will receive either dexamethasone or a placebo (normal saline) to evaluate its effectiveness in reducing chronic pain after thoracic surgery. Some findings suggest that while dexamethasone given through an IV might not always relieve pain after chest surgery, it can be helpful when used with other treatments. Overall, dexamethasone has shown promise in reducing pain after surgery. ^{2 3 4 6 7}

Who Is on the Research Team?

Veronique Brulotte, MD, MSc

Principal Investigator

Maisonneuve-Rosemont Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who are scheduled for elective thoracic surgery with a specific type of incision and pain relief method. It's not open to those already on cortisone or dexamethasone, anyone refusing participation, patients with conditions that don't allow the planned pain relief approach, or those on long-term opioid treatment.

Inclusion Criteria

I am scheduled for chest surgery with a specific type of cut and pain management.

You are classified as having a low to moderate risk for surgery, based on your overall health and medical history.

Exclusion Criteria

I cannot have an epidural in my upper back due to health reasons.

I am currently taking cortisone or dexamethasone.

You are taking strong pain medications regularly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive either dexamethasone 10 mg or normal saline intravenously pre-incision

Single dose

Post-operative Monitoring

Participants are monitored for post thoracotomy pain syndrome and inflammatory response

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview

The study tests if Dexamethasone given before surgery can reduce chronic post-surgery pain by tackling inflammation. Patients will either receive this drug or a saline solution as a comparison. The main goal is to see if there's less pain three months after thoracic surgery.

How Is the Trial Designed?

Group I: dexamethasone 10 mg Experimental Treatment 1 Intervention

Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously

Group II: normal saline Placebo Group 1 Intervention

Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Maisonneuve-Rosemont Hospital

Lead Sponsor

Trials

102

Recruited

38,300+

Published Research Related to This Trial

In a study of 90 patients undergoing major abdominal surgery, administering 5 mg of epidural dexamethasone either before or after the operation significantly reduced postoperative pain and the need for rescue analgesics compared to a control group without dexamethasone.

While there were no significant differences in nausea and vomiting among the groups, patients receiving dexamethasone at the end of the operation reported more frequent itching, indicating a potential side effect to consider.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of epidural administration of dexamethasone on postoperative pain: a randomized controlled study in radical subtotal gastrectomy. Jo, YY., Yoo, JH., Kim, HJ., et al.[2022]

In a study of 70 patients undergoing mastectomy, preoperative dexamethasone significantly reduced the incidence of postoperative nausea and vomiting (PONV) compared to placebo, with rates of 28.6% versus 60% shortly after surgery.

Dexamethasone also effectively decreased postoperative pain levels at multiple time points, leading to lower pain scores and reduced need for additional analgesics, with no reported adverse events, indicating its safety and efficacy in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative dexamethasone reduces postoperative pain, nausea and vomiting following mastectomy for breast cancer. Gómez-Hernández, J., Orozco-Alatorre, AL., Domínguez-Contreras, M., et al.[2022]

A single intravenous dose of dexamethasone significantly reduced postoperative pain scores at 2 and 24 hours after surgery, leading to lower opioid consumption and less need for additional pain relief.

Dexamethasone did not increase the risk of infections or delayed wound healing, although it did result in a slight increase in blood glucose levels 24 hours post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. Waldron, NH., Jones, CA., Gan, TJ., et al.[2022]

Epidural administration of dexamethasone provided effective pain relief after minor orthopedic surgery, lasting about 7 hours, and reduced the need for additional painkillers compared to the control group.

Combining epidural dexamethasone with IV dipyrone significantly extended pain relief to 17 hours and decreased overall painkiller consumption, while adding IV parecoxibe did not enhance the analgesic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia after Epidural Dexamethasone is Further Enhanced by IV Dipyrone, but Not IV Parecoxibe Following Minor Orthopedic Surgery. Lauretti, GR., Righeti, CC., Kitayama, AT.[2021]

In a study of 70 patients undergoing minimally invasive thoracic surgery, dexamethasone did not significantly reduce morphine consumption or postoperative pain scores compared to those who did not receive it.

However, patients who did not receive dexamethasone required more rescue pain therapy, suggesting that dexamethasone may help in managing pain as part of a multimodal approach, while also being safe with no increase in surgical wound infections or significant differences in postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone and postoperative analgesia in minimally invasive thoracic surgery: a retrospective cohort study. Umari, M., Paluzzano, G., Stella, M., et al.[2023]

In a study involving 40 patients undergoing thoracotomy, preoperative administration of dexamethasone did not significantly reduce postoperative pain or opioid consumption compared to a saline control group.

The study found no differences in pain intensity scores, quality of recovery, or length of hospital stay between the dexamethasone and control groups, indicating that a single dose of dexamethasone may not be effective for pain management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative dexamethasone for acute post-thoracotomy analgesia: a randomized, double-blind, placebo-controlled study. Joung, KW., Kim, HR., Kim, WJ., et al.[2019]

A meta-analysis of five randomized controlled trials found that adding epidural dexamethasone to local anesthetics significantly reduces postoperative morphine consumption by an average of 7.89 mg, indicating its efficacy in pain management.

Patients receiving epidural dexamethasone also required fewer rescue analgesic boluses, with a risk ratio of 0.51, suggesting that it effectively decreases the need for additional pain relief after abdominal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of epidural local anesthetic and dexamethasone in providing postoperative analgesia: A meta-analysis. Jebaraj, B., Khanna, P., Baidya, DK., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12307135/

Role of Dexamethasone in Reducing Postoperative Pain ...

Conclusion: A single intraoperative dose of dexamethasone significantly reduces early postoperative opioid use and pain intensity in cardiac ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091224002095

Dexamethasone and chronic postsurgical pain

The PADDI investigators have now presented enough data to convince us that indeed a single dose of dexamethasone is safe and effective.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11251116/

Pain management after thoracotomy with dexamethasone ...

Administering local dexamethasone + bupivacaine through a peripleural catheter can reduce postoperative pain, analgesic consumption, and length of hospital ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02112864

Dexamethasone for Reduction of Post Thoracotomy Pain ...

The hypothesis of this study is that dexamethasone, given pre operatively, would help reduce the incidence of post thoracotomy pain syndrome 3 months after ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S152168962400003X

Challenges in acute postoperative pain management ...

In summary, the available data revealed that intravenous steroids were not useful in providing pain relief after thoracic surgery. However, perineural ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12543256/

The Effect of Dexamethasone Administration on ...

The results of this study show that dexamethasone can reduce the severity of pain after abdominoplasty surgery. In the present study also ...

7.

bmcanesthesiol.biomedcentral.com

bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-024-02625-3

Pain management after thoracotomy with dexamethasone and ...

This study investigates the additive effect of local dexamethasone with bupivacaine as sole analgesic medication through a peripleural catheter after ...