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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Post thoracotomy pain syndrome still affects 50% of patients after a thoracic surgery. Pathogenesis is unclear but there is growing evidence that neuro inflammation may play a significant role. Dexamethasone is a very potent anti-inflammatory drug. The hypothesis of this study is that dexamethasone, given pre operatively, would help reduce the incidence of post thoracotomy pain syndrome 3 months after surgery, by reducing the inflammatory response, in patients undergoing elective thoracic surgery that includes thoracic epidural analgesia.

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 dexamethasone generally safe for humans?

Dexamethasone is commonly used to prevent nausea and vomiting after surgery and has been studied for pain relief. Some studies have explored its effects on pain and side effects, but the safety of a single dose is still being evaluated. It is known to be a potent anti-inflammatory and antiemetic (prevents nausea and vomiting) drug. ^{1 2 3 4 5}

How is the drug dexamethasone unique for treating chronic pain after thoracic surgery?

Dexamethasone is unique because it is not only used to reduce inflammation but also helps in managing pain and preventing nausea and vomiting after surgery. It can be administered before surgery to help reduce pain and the need for other pain medications like morphine, making it a versatile option for postoperative care. ^{1 2 5 6 7}

What data supports the effectiveness of the drug Dexamethasone for chronic pain after thoracic surgery?

Research shows that Dexamethasone can help reduce pain after surgery. Studies have found it effective in lowering pain levels and reducing the need for other pain medications after various types of surgeries, including thoracic and abdominal surgeries. ^{1 2 3 5 6}

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 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]

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]

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]

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 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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Preoperative dexamethasone for acute post-thoracotomy analgesia: a randomized, double-blind, placebo-controlled study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Dexamethasone and postoperative analgesia in minimally invasive thoracic surgery: a retrospective cohort study. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Efficacy of epidural local anesthetic and dexamethasone in providing postoperative analgesia: A meta-analysis. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Analgesia after Epidural Dexamethasone is Further Enhanced by IV Dipyrone, but Not IV Parecoxibe Following Minor Orthopedic Surgery. [2021]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of epidural administration of dexamethasone on postoperative pain: a randomized controlled study in radical subtotal gastrectomy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Preoperative dexamethasone reduces postoperative pain, nausea and vomiting following mastectomy for breast cancer. [2022]