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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two drugs, dexamethasone (a corticosteroid) and dexmedetomidine (a sedative), reduce pain after ACL (knee ligament) surgery. Researchers aim to determine if using these drugs alone or together eases recovery by reducing pain. Participants will receive either one of the drugs, both drugs combined, or a placebo (inactive treatment). Individuals who have undergone ACL repair and do not have diabetes, chronic pain, or a history of drug dependence may be suitable for this study. As a Phase 4 trial, the study focuses on understanding how these FDA-approved and effective treatments can benefit more patients.

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 is the safety track record for these treatments?

Research has shown that dexamethasone and dexmedetomidine are generally safe and effective for managing post-surgical pain. Studies have found that dexamethasone reduces pain and decreases the need for painkillers after surgery. It also helps with swelling and lessens nausea and fatigue.

For dexmedetomidine, research indicates it lowers pain levels and improves recovery after surgery. It stabilizes vital signs and enhances overall treatment effectiveness. When used together, dexamethasone and dexmedetomidine provide better pain relief than using either one alone.

Both treatments have a strong safety record in humans, supported by multiple studies. Participants in past trials generally tolerated these treatments well, with few serious side effects reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about combining dexamethasone and dexmedetomidine for post-op ACL repair pain because this pairing offers a potentially enhanced approach to pain management. Unlike traditional pain treatments like opioids, which can have significant side effects and addiction risks, this combination targets pain through anti-inflammatory effects (dexamethasone) and sedation with analgesia (dexmedetomidine). Dexamethasone reduces swelling and inflammation, while dexmedetomidine provides calming and pain-relief effects, potentially reducing the need for opioids. Additionally, the use of these agents together could offer a more balanced and effective pain control strategy, minimizing side effects and improving recovery experiences for patients.

What evidence suggests that this trial's treatments could be effective for post-op ACL repair pain?

Research has shown that dexamethasone can reduce swelling and ease pain, nausea, and tiredness after surgery. It also provides longer-lasting pain relief. In this trial, some participants will receive dexamethasone alone, while others will receive dexmedetomidine alone. Studies indicate that dexmedetomidine effectively reduces pain and decreases the need for other pain medications after surgery. Additionally, one arm of this trial will test the combination of both dexamethasone and dexmedetomidine, which might improve pain control further, potentially reducing moderate-to-severe pain by an additional 20%. These treatments aim to make recovery from ACL repair surgery less painful and more comfortable. ^{1 6 7 8 9}

Who Is on the Research Team?

Richard Brull, MD

Principal Investigator

Women's College Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9017928/

Low-dose Perioperative Dexamethasone Improves 24-hour ... The administration of dexamethasone in the perioperative period can decrease inflammatory response and hence reduce post-operative pain, nausea, and fatigue.

2. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effect-of-dexamethasone-and-sodium-chloride-on-pain-after-acl-surgery-in-adults/

Study on the Effect of Dexamethasone and Sodium ... The trial aims to provide valuable information on whether dexamethasone can effectively reduce pain and improve recovery after ACL surgery.

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01440-4

Effects of the addition of dexamethasone on postoperative ... The present results confirm that the addition of dexamethasone also prolongs the duration of analgesia and motor block of proximal lower ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2020/04170/the_efficacy_of_dexamethasone_on_pain_management.4.aspx

The efficacy of dexamethasone on pain management ... Overall, compared with control group for knee arthroscopy, dexamethasone supplementation has no notable effect on pain scores at 4 to 6 hours (Std. MD = 0.99; ...

5. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/aspiration-and-corticosteroid-injection-are-safe-after-acl-injury

Aspiration and Corticosteroid Injection Are Safe After ACL Injury Aspiration and corticosteroid injection in the knee is safe and beneficial for young, healthy patients following anterior cruciate ligament (ACL) rupture and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29555525/

The efficacy and safety of dexamethasone for pain ... Conclusion: Dexamethasone decreases pain scores within 48 h postoperatively and is associated with significantly reduced narcotic consumption.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0976566225001651

Perioperative dexamethasone: Effects on length of stay, ... This investigation aims to evaluate the effects of perioperative dexamethasone on LOS, post-operative outcomes, and adverse event rates for trauma patients.

8. journals.lww.com journals.lww.com/md-journal/fulltext/2018/08310/a_meta_analysis_of_dexamethasone_for_pain.3.aspx

A meta-analysis of dexamethasone for pain management in... Previous studies have demonstrated that dexamethasone appeared to be effective and safe for postoperative pain control in arthroplasties. Additionally, ...

9. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/143092-efficacy-of-weight-based-low-dose-intravenous-dexamethasone-for-pain-management-following-total-knee-arthroplasty-a-retrospective-case-matched-study

Efficacy of Weight-Based Low-Dose Intravenous ... Results. The dexamethasone group demonstrated significantly lower pain scores at all measured intervals up to 60 hours postoperatively (p < 0. ...