252 Participants Needed

Dexamethasone + Dexmedetomidine for Post-Op ACL Repair Pain

(AADDCToR Trial)

DB
Overseen ByDidem Bozak
Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Women's College Hospital
Stay on Your Current MedsYou can continue your current medications while participating
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

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.12345

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.12345

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.12367

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.12367

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.13489

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.13489

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, FRCPC - Academics at ...

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.
See 8 more

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
4Treatment groups
Active Control
Placebo Group
Group I: Dexamethasone and DexmedetomidineActive Control3 Interventions
Freezing+dexamethasone(4mg)+dexmedetomidine(50ug) + 0.5 ml of saline
Group II: Dexamethasone vs. Control comparisonActive Control2 Interventions
Freezing + dexamethasone(4mg)+1 ml of saline
Group III: Dexmedetomidine vs. Control comparisonActive Control2 Interventions
Freezing + dexmedetomidine(50ug) + 1.5 ml of saline
Group IV: Control Group-PlaceboPlacebo Group1 Intervention
Freezing + 2ml saline

Find a Clinic Near You

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.
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.
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.
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]

References

Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. [2018]
A randomised controlled trial of intravenous dexmedetomidine added to dexamethasone for arthroscopic rotator cuff repair and duration of interscalene block. [2023]
Analgesic duration of interscalene block after outpatient arthroscopic shoulder surgery with intravenous dexamethasone, intravenous dexmedetomidine, or their combination: a randomized-controlled trial. [2023]
Postoperative analgesic effects of dexamethasone sodium phosphate in bunion surgery. [2016]
Analgesic comparison between perineural and intravenous dexamethasone for shoulder arthroscopy: a meta-analysis of randomized controlled trials. [2022]
Low-dose dexamethasone during arthroplasty: What do we know about the risks? [2020]
The effect of dexamethasone on postoperative pain and emesis after intrathecal neostigmine. [2022]
Use of Dexmedetomidine With Dexamethasone for Extended Pain Relief in Adductor Canal/Popliteal Nerve Block During Achilles Tendon Repair. [2021]
Analgesic Effect of Dexamethasone after Arthroscopic Knee Surgery: A Randomized Controlled Trial. [2020]
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