Dexmedetomidine + Ropivacaine for Shoulder Pain and Postoperative Pain
(DEXBIB Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a history of chronic pain with daily opioid use, you may not be eligible to participate.
What data supports the effectiveness of the treatment Continuous Interscalene Brachial Plexus Block with Dexmedetomidine and Ropivacaine for shoulder pain?
Is the combination of Dexmedetomidine and Ropivacaine safe for use in humans?
Research indicates that Ropivacaine is generally safe with a lower risk of heart-related side effects compared to other anesthetics, and Dexmedetomidine is commonly used to enhance the effects of local anesthetics. However, specific safety data for the combination of Dexmedetomidine and Ropivacaine in humans is not detailed in the available studies.12456
How is the treatment of dexmedetomidine and ropivacaine for shoulder pain different from other treatments?
This treatment is unique because it combines dexmedetomidine, which enhances pain relief, with ropivacaine, a local anesthetic, in a continuous interscalene brachial plexus block. This combination aims to provide longer-lasting pain relief after shoulder surgery compared to using ropivacaine alone.12789
What is the purpose of this trial?
Arthroscopic shoulder surgery is increasingly performed in an outpatient setting and post-operative pain management is often a real challenge as those surgeries are well recognized for their high level of pain which often affects physical rehabilitation. The interscalene block is a largely used anesthetic technique to perform these surgeries whilst avoiding general anesthesia (GA) and to provide postoperative analgesia. However, the painful period often exceeds the duration of a single shot block, thus affecting patient recovery. Some specialized centers use a continuous catheter and elastomeric pump in order to prolong the duration of analgesia. However, several logistical, professional and financial constraints limit the use of these catheters and pumps in a great number of outpatient centers. On the other hand, perineural dexmedetomidine is increasingly used as an adjuvant to improve block onset, analgesia duration and patient satisfaction.The use of adjuvants such as perineural dexmedetomidine added to a single shot interscalene block appears to be an interesting option to prolong postoperative analgesia without the limitations imposed by a continuous catheter and elastomeric pumps in arthroscopic shoulder surgeries.
Research Team
Ariane Clairoux, MD
Principal Investigator
Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria
Adults over 18, with a health status of ASA I-III, undergoing elective outpatient shoulder surgery and returning home the same day. Excluded are those under 18 or weighing less than 50 kg, without post-op support at home for the first 72 hours, communication issues, significant psychiatric/cognitive conditions, severe medical disorders like heart disease or bleeding problems, chronic pain with daily opioid use in past three months, pregnancy, need for general anesthesia during surgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a single shot interscalene block with dexmedetomidine added to ropivacaine or a continuous interscalene block with ropivacaine for elective arthroscopic shoulder surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of Quality of Recovery and patient satisfaction
Long-term follow-up
Participants may be monitored for any long-term effects or complications related to the treatment
Treatment Details
Interventions
- Continuous Interscalene Brachial Plexus Block
- Dexmedetomidine
- Ropivacaine
- Single Shot Interscalene Brachial Plexus Block Group with Dexmedetomidine Added to Ropivacaine Group
Continuous Interscalene Brachial Plexus Block is already approved in United States, European Union, Canada for the following indications:
- Postoperative pain management for arthroscopic shoulder surgery
- Postoperative pain management for arthroscopic shoulder surgery
- Postoperative pain management for arthroscopic shoulder surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ciusss de L'Est de l'Île de Montréal
Lead Sponsor