120 Participants Needed

Dexmedetomidine + Ropivacaine for Postoperative Pain Management

VR
Overseen ByVendhan Ramanujam, M.D.
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of different pain management combinations for individuals undergoing hip replacement surgery. It compares two options: one group receives a nerve block with ropivacaine, a pain-relieving medication, while the other group receives the same nerve block with an added boost from dexmedetomidine, which aids in pain relief and sedation. The goal is to determine which combination provides better pain relief after surgery. Suitable candidates for this trial are those planning elective hip replacement surgery who have not had prior surgery in that area. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.

What is the safety track record for these treatments?

Research shows that using dexmedetomidine with ropivacaine for post-surgery pain relief is generally safe. Studies have found that this combination can extend pain relief with minimal side effects. One study found that adding dexmedetomidine to ropivacaine improved pain control and acted more quickly. Another study suggested this combination might even reduce the risk of post-surgery confusion.

Although dexmedetomidine is not new and is approved for other uses, these findings offer some confidence about its safety when combined with ropivacaine. Several studies have tested the combination, and it is considered well-tolerated, meaning most people did not experience serious problems. Always consult your doctor to determine if joining a trial is right for you.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of dexmedetomidine and ropivacaine for managing postoperative pain because it promises a new level of pain relief with potentially fewer side effects. Unlike standard treatments that often rely solely on opioids for pain control, this combination uses dexmedetomidine, which works on different receptors to enhance pain relief without the same risk of addiction. Additionally, dexmedetomidine has sedative properties that can help with anxiety and discomfort during recovery, making it a holistic option for postoperative care. This innovative approach targets pain more effectively and could lead to a smoother, more comfortable recovery for patients.

What evidence suggests that this trial's treatments could be effective for postoperative pain management?

Research has shown that combining dexmedetomidine with ropivacaine can enhance pain relief after surgery. In this trial, one group of participants will receive only ropivacaine, while another group will receive both ropivacaine and dexmedetomidine. Studies have found that this combination reduces pain for longer periods. Additionally, using dexmedetomidine with ropivacaine can improve overall recovery quality and decrease the amount of ropivacaine needed for effective pain relief. Overall, evidence strongly supports that adding dexmedetomidine to ropivacaine improves post-surgery pain management.34567

Are You a Good Fit for This Trial?

This trial is for patients undergoing hip replacement surgery who will receive spinal or general anesthesia. They are looking at how well a nerve block works for pain after the operation, using either ropivacaine alone or with dexmedetomidine.

Inclusion Criteria

ASA 1-3 classifications
I am scheduled for elective total hip replacement surgery.
I am between 18 and 80 years old.

Exclusion Criteria

Known allergy to study medications
Chronic opioid consumption (>3 months)
My BMI is 40 or higher.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo hip replacement surgery with a suprainguinal fascia iliaca block using either ropivacaine alone or ropivacaine with dexmedetomidine

Surgery day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain scores and opioid consumption at various intervals post-surgery

48 hours
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Dexmedetomidine

Trial Overview

The study compares two methods of managing postoperative pain: one group receives a suprainguinal fascia iliaca block with ropivacaine, and another group gets the same block but adds dexmedetomidine to potentially improve pain control.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Ropivacaine plus DexmedetomidineExperimental Treatment2 Interventions
Group II: RopivacaineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials
275
Recruited
71,400+

Citations

Analgesic effect of ropivacaine combined with ...

The results of this review and meta-analysis support that dexmedetomidine, as an adjuvant to ropivacaine, can improve postoperative analgesia of surgery and ...

Effects of dexmedetomidine as an adjuvant to ropivacaine or ...

The meta-analysis demonstrated that ropivacaine combined with dexmedetomidine significantly prolonged the duration of postoperative analgesia ...

Dexmedetomidine Combined With Ropivacaine for ...

The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and ...

Evaluation of ropivacaine combined with dexmedetomidine...

We compared the efficiency and safety of ropivacaine alone (R group) and ropivacaine combined with dexmedetomidine (RD group).

Effect of dexmedetomidine on the median ...

Dexmedetomidine can significantly reduce the EC50 of ropivacaine and improve the quality of postoperative recovery for patients undergoing laparoscopic ...

The effect and safety of dexmedetomidine added to...

Conclusion: Dexmedetomidine added to ropivacaine in BPB has a better analgesia effect (shorter onset time and longer duration) compared to ropivacaine alone. ...

Efficacy and safety of intra-articular dexmedetomidine in ...

The main purposes of this study were to compare the efficacy and safety of adding intra-articular dexmedetomidine as an adjunct to local ...