Dexamethasone + Dexmedetomidine for Post-Op ACL Repair Pain

(AADDCToR Trial)

Overseen By Didem Bozak

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Women's College Hospital

Disqualifiers: Diabetes, Chronic pain, Opioids, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

252 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a history of long-term opioid use or certain medical conditions, you may not be eligible to participate.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for guidance.

What data supports the idea that Dexamethasone + Dexmedetomidine for Post-Op ACL Repair Pain is an effective drug?

The available research shows that Dexamethasone and Dexmedetomidine can be effective in managing post-surgery pain. For example, a study on shoulder surgery found that using these drugs together prolonged the time before patients needed additional pain medication. Another study on bunion surgery showed that Dexamethasone significantly reduced pain compared to a placebo. These findings suggest that the combination of Dexamethasone and Dexmedetomidine can help reduce pain after surgery, making it a potentially effective option for Post-Op ACL Repair Pain. ^{1 2 3 4 5}

What data supports the effectiveness of the drug combination of Dexamethasone and Dexmedetomidine for post-op ACL repair pain?

Research shows that Dexamethasone can reduce pain and inflammation after surgeries like knee and bunion surgeries, while Dexmedetomidine can prolong pain relief when used with nerve blocks. This suggests that the combination may help manage pain after ACL repair surgery. ^{1 2 3 4 5}

What safety data exists for using dexamethasone and dexmedetomidine in post-op pain management?

Existing safety data indicates that low-dose dexamethasone is generally safe for perioperative use, with no significant increase in surgical site infections or impaired wound healing. It is effective in reducing postoperative nausea and vomiting (PONV) and has dose-dependent effects on pain and recovery. Dexmedetomidine, when combined with dexamethasone, can shorten the time to oral morphine consumption but may cause intra-operative hypotension. Overall, the combination of dexamethasone and dexmedetomidine appears to be safe, but careful monitoring is advised due to potential side effects like hypotension. ^{1 2 3 6 7}

Is the combination of dexamethasone and dexmedetomidine safe for post-operative pain management?

Research shows that dexamethasone is generally safe in low doses for surgery, with no significant increase in surgical site infections or wound healing issues. Dexmedetomidine may cause low blood pressure during surgery, but no other major safety concerns were noted. ^{1 2 3 6 7}

Is the drug used in the trial titled 'Dexamethasone + Dexmedetomidine for Post-Op ACL Repair Pain' a promising treatment?

Yes, the combination of dexamethasone and dexmedetomidine is promising for pain relief after surgery. Studies show they can extend pain relief duration and reduce the need for additional pain medication. ^{1 3 4 8 9}

How does the drug combination of dexamethasone and dexmedetomidine for post-op ACL repair pain differ from other treatments?

The combination of dexamethasone and dexmedetomidine is unique because it potentially extends pain relief after surgery by using both an anti-inflammatory steroid (dexamethasone) and a sedative with pain-relieving properties (dexmedetomidine), which may reduce the need for opioids and provide longer-lasting pain control compared to traditional treatments. ^{1 3 4 8 9}

What is the purpose of this trial?

The aim of this multi-centered study is to evaluate the effects of two distinct Adductor Canal Block (ACB) adjuncts, dexamethasone and dexmedetomidine, and their combination, on postoperative analgesia in patients undergoing Anterior Cruciate Ligament (ACL) Repair.

Research Team

Richard Brull, MD

Principal Investigator

Women's College Hospital

Eligibility Criteria

This trial is for English-speaking individuals with a BMI under 40, who are in generally good health (ASA 1-3), and are about to undergo surgery for an Anterior Cruciate Ligament (ACL) injury.

Inclusion Criteria

English Speaking

BMI <40

I am in good to moderate health with manageable medical problems.

Exclusion Criteria

I have diabetes.

I don't have conditions that prevent me from getting regional anesthesia.

I have been taking opioids for a long time or have chronic pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo ACL repair surgery with adductor canal block and receive either dexamethasone, dexmedetomidine, their combination, or placebo to evaluate postoperative analgesia

1 day

1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for pain relief and opioid consumption in the PACU and up to 24 hours post-surgery

24 hours

Continuous monitoring

Follow-up

Participants are monitored for safety, effectiveness, and complications related to the nerve block and opioid use

2 weeks

2 visits (in-person)

Treatment Details

Interventions

• Dexamethasone
• Dexmedetomidine
• Saline

Trial Overview The study is testing the effectiveness of two drugs, Dexamethasone and Dexmedetomidine, used alone or combined as add-ons to the Adductor Canal Block (ACB), a pain management technique after ACL repair surgery.

Participant Groups

Group I: Dexamethasone and Dexmedetomidine Active Control 3 Interventions

Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline

Group II: Dexamethasone vs. Control comparison Active Control 2 Interventions

Freezing + dexamethasone(4mg)+1 ml of saline

Group III: Dexmedetomidine vs. Control comparison Active Control 2 Interventions

Freezing + dexmedetomidine(50ug) + 1.5 ml of saline

Group IV: Control Group-Placebo Placebo Group 1 Intervention

Freezing + 2ml saline

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 108 patients undergoing total knee arthroplasty, administering two doses of low-dose dexamethasone significantly reduced inflammatory markers (CRP and IL-6) and provided better pain relief compared to a placebo, particularly at 24 hours post-surgery.

Dexamethasone also decreased the incidence of postoperative nausea and vomiting (PONV) and postoperative fatigue, while showing no increase in the risk of surgical complications, indicating it is both effective and safe for enhancing recovery after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. Xu, B., Ma, J., Huang, Q., et al.[2018]

In a study of 122 participants undergoing shoulder surgery, intravenous dexmedetomidine combined with dexamethasone significantly reduced the time to first oral morphine intake, suggesting it may enhance pain management after nerve block procedures.

However, the use of dexmedetomidine was associated with a higher incidence of intra-operative hypotension, indicating a potential safety concern that needs to be monitored during its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of intravenous dexmedetomidine added to dexamethasone for arthroscopic rotator cuff repair and duration of interscalene block. Albrecht, E., Capel, D., Rossel, JB., et al.[2023]

In a study of 198 patients undergoing shoulder surgery, intravenous dexamethasone significantly prolonged the duration of analgesic blocks compared to dexmedetomidine, with block durations of 24.5 hours for dexamethasone versus 16.0 hours for dexmedetomidine.

Combining dexamethasone and dexmedetomidine did not provide any additional benefit over using dexamethasone alone, indicating that dexamethasone is the more effective adjunct for enhancing pain relief after interscalene blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic duration of interscalene block after outpatient arthroscopic shoulder surgery with intravenous dexamethasone, intravenous dexmedetomidine, or their combination: a randomized-controlled trial. Rodrigues, D., Amadeo, RJJ., Wolfe, S., et al.[2023]

In a double-blind study involving 51 patients undergoing bunion surgery, dexamethasone sodium phosphate significantly reduced postoperative pain compared to normal saline, as reported by patients at 24 hours and from 4 to 7 days after surgery.

No complications were linked to the use of dexamethasone, supporting its safety and efficacy as a postoperative analgesic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative analgesic effects of dexamethasone sodium phosphate in bunion surgery. Curda, GA.[2016]

A meta-analysis of five randomized controlled trials found that perineural dexamethasone provides similar pain relief and block duration compared to intravenous dexamethasone after shoulder arthroscopy, indicating both methods are effective.

There were no significant differences in pain scores, opioid consumption, or incidence of nausea/vomiting between the two administration routes, suggesting that either method can be safely used for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic comparison between perineural and intravenous dexamethasone for shoulder arthroscopy: a meta-analysis of randomized controlled trials. Huang, L., Li, P., Zhang, L., et al.[2022]

A systematic review of 8 studies involving 1335 patients found no incidence of surgical site infections (SSI) associated with a single low dose of dexamethasone during hip and knee arthroplasty, suggesting it is safe in this context.

Low-dose dexamethasone effectively prevents post-operative nausea and vomiting (PONV) and improves post-operative pain and recovery quality, although a larger study of 27,205 patients would be needed to definitively assess its safety regarding wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose dexamethasone during arthroplasty: What do we know about the risks? Wegener, JT., Kraal, T., Stevens, MF., et al.[2020]

In a study involving 60 patients undergoing inguinal herniorrhaphy, a single dose of 10 mg dexamethasone did not improve pain relief or reduce the incidence of postoperative nausea and vomiting (PONV) after spinal anesthesia with tetracaine and neostigmine.

The findings suggest that dexamethasone does not enhance the analgesic effects of neostigmine or decrease the severity of nausea and vomiting following intrathecal administration, indicating it may not be beneficial in this specific postoperative context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dexamethasone on postoperative pain and emesis after intrathecal neostigmine. Tan, PH., Liu, K., Peng, CH., et al.[2022]

The combination of dexmedetomidine and dexamethasone with local anesthetics in a regional nerve block provided significant postoperative pain relief for a patient undergoing Achilles tendon repair, demonstrating effective analgesia without the need for additional opioid medication.

This case supports the idea that using adjuncts like dexmedetomidine and dexamethasone can enhance the duration and effectiveness of regional anesthesia, potentially improving patient outcomes in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Dexmedetomidine With Dexamethasone for Extended Pain Relief in Adductor Canal/Popliteal Nerve Block During Achilles Tendon Repair. Kassem, H., Urits, I., Viswanath, O., et al.[2021]

In a study of 78 patients undergoing arthroscopic knee surgery, a single dose of intravenous dexamethasone did not significantly reduce postoperative pain intensity compared to a saline control, with pain scores being higher in the dexamethasone group at 4 hours post-surgery.

There was no significant difference in total opioid use between the dexamethasone and saline groups, indicating that morphine remained the primary source of pain relief, and suggesting that dexamethasone may not be effective as a coanalgesic in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic Effect of Dexamethasone after Arthroscopic Knee Surgery: A Randomized Controlled Trial. Moyano, J., García, M., Caicedo, M.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. [2018]

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

A randomised controlled trial of intravenous dexmedetomidine added to dexamethasone for arthroscopic rotator cuff repair and duration of interscalene block. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Analgesic duration of interscalene block after outpatient arthroscopic shoulder surgery with intravenous dexamethasone, intravenous dexmedetomidine, or their combination: a randomized-controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Postoperative analgesic effects of dexamethasone sodium phosphate in bunion surgery. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Analgesic comparison between perineural and intravenous dexamethasone for shoulder arthroscopy: a meta-analysis of randomized controlled trials. [2022]

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

Low-dose dexamethasone during arthroplasty: What do we know about the risks? [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The effect of dexamethasone on postoperative pain and emesis after intrathecal neostigmine. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Use of Dexmedetomidine With Dexamethasone for Extended Pain Relief in Adductor Canal/Popliteal Nerve Block During Achilles Tendon Repair. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Analgesic Effect of Dexamethasone after Arthroscopic Knee Surgery: A Randomized Controlled Trial. [2020]