Dexmedetomidine + Ropivacaine for Shoulder Pain and Postoperative Pain

(DEXBIB Trial)

Overseen By Nadia NG Godin, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Must not be taking: Opioids

Disqualifiers: Pregnancy, Allergy to anesthetics, 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)

Compensation: Varies

Number of Visits: 3

Duration: Immediate postoperative period to 72 hours

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to manage pain after shoulder surgery by comparing two methods. One method uses a single injection with dexmedetomidine, a sedative, to extend pain relief. The other method uses a continuous infusion through a catheter. Suitable participants have planned outpatient shoulder surgery and expect to go home the same day. As an unphased trial, this study offers an opportunity to contribute to innovative pain management solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adding dexmedetomidine to ropivacaine for shoulder surgery can prolong pain relief and increase comfort post-procedure. One study found that this combination reduced the need for additional pain medication. Another study confirmed these findings, demonstrating that the mix extended the effect of the nerve block, aiding post-surgery pain management.

For ongoing ropivacaine treatment, research indicates it provides lasting pain relief, even beyond two days after surgery, potentially reducing the need for painkillers during recovery. Both treatments have generally been well-tolerated in past studies, suggesting they are safe for managing pain after shoulder surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine dexmedetomidine with ropivacaine to potentially enhance pain relief after shoulder surgery. Unlike standard treatments that use only ropivacaine, this approach adds dexmedetomidine, which may prolong and intensify the pain-relieving effects. The single-shot method is particularly unique as it delivers a potent combination directly to nerve roots, possibly offering longer-lasting relief compared to continuous infusion methods. By exploring these new combinations and delivery methods, researchers hope to provide patients with more effective and sustained postoperative pain management options.

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

This trial will compare two approaches for managing pain after shoulder surgery. One treatment arm adds dexmedetomidine to a ropivacaine nerve block. Research shows this combination can greatly extend pain relief. Studies have found that it not only prolongs the nerve block but also improves overall pain control and reduces the need for additional pain medication.

The other treatment arm uses ropivacaine alone in a continuous interscalene brachial plexus block, which effectively eases pain after surgery. Strong evidence suggests this method provides excellent pain relief for up to 48 hours post-surgery. Both treatments in this trial have shown great promise in effectively managing pain after shoulder surgeries. ^{1 2 6 7 8}

Who Is on the Research Team?

Ariane Clairoux, MD

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Are You a Good Fit for This Trial?

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

ASA status of I-III

I am scheduled for elective shoulder surgery.

I expect to go home the same day as my surgery, staying less than 12 hours in the hospital.

Exclusion Criteria

I will undergo surgery that needs me to be put to sleep.

I don't have bleeding disorders, severe lung disease, or infections where injections are given.

I have chosen not to participate in this trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

Immediate postoperative period to 72 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of Quality of Recovery and patient satisfaction

72 hours

2 visits (in-person)

Long-term follow-up

Participants may be monitored for any long-term effects or complications related to the treatment

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Interscalene Brachial Plexus Block
• Dexmedetomidine
• Ropivacaine
• Single Shot Interscalene Brachial Plexus Block Group with Dexmedetomidine Added to Ropivacaine Group

Trial Overview The trial is testing two methods to manage pain after shoulder surgery: one group receives a single shot of ropivacaine mixed with dexmedetomidine (a sedative), while another gets continuous pain relief through a catheter. The goal is to see if adding dexmedetomidine can extend pain relief without needing complex equipment.

How Is the Trial Designed?

Group I: single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine Experimental Treatment 1 Intervention

A total of 150 mg of ropivacaine 0.5% will be prepared, 125 mg (25mL) will be mixed with a dose of 2 mcg/kg IBW of dexmedetomidine (100 mcg/mL dexmedetomidine hydrochloride; Precedex, Hospira Inc, Lake Forest, IL). The total of 25 mL (125 mg or ropivacaine 0.5%) with dexmedetomidine will be injected perineurally at the level of the roots and a 5 mL (25 mg) will be injected between the sternocleidomastoid muscle and anterior scalene for the superficial cervical plexus block.

Group II: continuous interscalene brachial plexus block with ropivacaine Active Control 1 Intervention

A total of 100 mg (20 mL) of ropivacaine 0,5% will be injected perineurally at the level of the roots using the Tuohy needle. The 19 G arrow catheter will then be introduced through the Tuohy needle and we will leave 4 cm of the catheter perineurally. An additional 25 mg (5 mL) of ropivacaine 0,5% will be injected using the catheter to make sure the catheter is in a correct position. An additional 5 mL (25 mg) of ropivacaine 0.5 % will be injected between the sternocleidomastoid muscle and anterior scalene for the superficial cervical plexus block using an ultrasound in-plane approach with a 22 G 80-mm ultrasound needle (Pajunk SonoTAP II, Germany) or with a standard 25G 1 1/2 inches needle. After the surgery, an infusion of ropivacaine 0,2% at a standard rate of 5 mL/h will be started using an elastomeric pump of 300 mL (Baxter Corporation, Mississauga, Ontario).

Continuous Interscalene Brachial Plexus Block is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Interscalene Block for:

• Postoperative pain management for arthroscopic shoulder surgery

Approved in European Union as Interscalene Block for:

• Postoperative pain management for arthroscopic shoulder surgery

Approved in Canada as Interscalene Block for:

• Postoperative pain management for arthroscopic shoulder surgery

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Published Research Related to This Trial

In a study of 126 patients receiving continuous infusions of 0.25% bupivacaine after upper extremity surgery, over 70% reported postoperative pain scores of 4 or less, indicating effective pain management.

While the method was generally effective and easy to implement, 14.3% of patients experienced complications, primarily catheter dislodgement and pain at the insertion site, highlighting the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative continuous interscalene brachial plexus blockade for hand surgery. Koh, DL., Lim, BH.[2020]

In a study of 66 patients undergoing arthroscopic shoulder surgery, co-administering intravenous dexamethasone and dexmedetomidine significantly prolonged the time to first rescue analgesic request to 66.3 hours, compared to 17.4 hours for dexamethasone alone and 10.9 hours for the control group.

Both dexamethasone and the combination treatment resulted in lower pain scores, reduced opioid consumption, less sleep disruption, and higher patient satisfaction, with no significant increase in blood glucose levels, indicating a safe profile for these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in postoperative pain control by combined use of intravenous dexamethasone with intravenous dexmedetomidine after interscalene brachial plexus block for arthroscopic shoulder surgery: A randomised controlled trial. Kang, RA., Jeong, JS., Yoo, JC., et al.[2019]

In a study involving 90 adult patients undergoing upper limb surgeries, the addition of dexmedetomidine to ropivacaine significantly prolonged both sensory and motor block durations compared to ropivacaine alone.

Patients receiving dexmedetomidine experienced a longer duration of analgesia (704.8 minutes) compared to those who received only ropivacaine (593.19 minutes), indicating that dexmedetomidine enhances the effectiveness of local anesthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dexmedetomidine as an adjuvant to ropivacaine in ultrasound-guided supraclavicular brachial plexus Block: A prospective, randomized, double-blind study. Mangal, V., Mistry, T., Sharma, G., et al.[2022]

In a study of 62 patients undergoing shoulder surgery, both 8 ml/h and 6 ml/h infusion rates of 0.2% ropivacaine for continuous interscalene brachial plexus block provided similar pain relief and patient satisfaction, indicating effective analgesia at both rates.

Lowering the infusion rate to 6 ml/h is recommended to reduce the risk of local anesthetic toxicity while maintaining effective pain management after shoulder surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical comparison of continuous interscalene brachial plexus block with different basal infusion rates of 0.2% ropivacaine for shoulder surgery. Yang, CW., Jung, SM., Kwon, HU., et al.[2021]

In a study of 44 patients undergoing arthroscopic shoulder surgery, adding 0.5 μg/kg dexmedetomidine to 0.25% ropivacaine significantly prolonged the duration of postoperative analgesia from 8.25 hours to 11.55 hours.

Patients receiving the combination treatment reported lower pain scores, reduced need for additional pain medication (sufentanil), and higher satisfaction with their pain management compared to those receiving ropivacaine alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of interscalene brachial plexus block with dexmedetomidine and ropivacaine on postoperative analgesia in patients undergoing arthroscopic shoulder surgery: a randomized controlled clinical trial. Luan, H., Hao, C., Li, H., et al.[2023]

A network meta-analysis of 25 studies involving 2,194 patients found that combining dexmedetomidine and dexamethasone significantly prolongs analgesia after interscalene block for shoulder surgery, with an average increase of 22.13 minutes compared to control.

Peripheral administration of dexamethasone alone also effectively extended analgesic duration and reduced opioid use, making it a strong option for enhancing pain management in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of dexmedetomidine and dexamethasone as adjuvants to the ultrasound-guided interscalene nerve block in arthroscopic shoulder surgery: a systematic review and Bayesian network meta-analysis of randomized controlled trials. Wei, XM., Liu, Z., Lv, LC., et al.[2023]

In a study involving outpatients undergoing shoulder surgery, both 0.125% bupivacaine and 0.2% ropivacaine used in continuous interscalene brachial plexus blocks resulted in similar levels of respiratory function impairment and pain relief, indicating that neither drug provided a clear advantage in these areas.

Despite the hypothesis that ropivacaine would cause less respiratory dysfunction due to its preferential sensory fiber blockade, the results showed no significant differences in forced expiratory volume, diaphragmatic excursion, or opioid consumption between the two anesthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of continuous interscalene brachial plexus block with 0.125% bupivacaine vs 0.2% ropivacaine on pain relief, diaphragmatic motility, and ventilatory function. Choromanski, DW., Patel, PS., Frederick, JM., et al.[2018]

In a study of 60 patients undergoing shoulder surgery, a continuous infusion of local anesthetic did not result in lower morphine consumption compared to a single injection, indicating no superior analgesia in the context of multimodal pain management.

Both groups showed similar pain scores and functional outcomes, suggesting that the addition of a continuous infusion may not be necessary when using a comprehensive multimodal analgesic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-bolus injection of local anesthetic, with or without continuous infusion, for interscalene brachial plexus block in the setting of multimodal analgesia: a randomized controlled unblinded trial. Rhyner, P., Cachemaille, M., Goetti, P., et al.[2023]

In a study involving 60 patients undergoing upper limb orthopedic surgery, the addition of dexmedetomidine to 0.75% ropivacaine significantly reduced the onset time for both sensory and motor blocks compared to ropivacaine alone.

The combination of dexmedetomidine and ropivacaine also significantly prolonged the duration of both sensory and motor blockade, enhancing the effectiveness of the interscalene brachial plexus block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dexmedetomidine as an Adjuvant to 0.75% Ropivacaine in Interscalene Brachial Plexus Block Using Nerve Stimulator: A Prospective, Randomized Double-blind Study. Rashmi, HD., Komala, HK.[2022]

Citations

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a randomized, double-blinded, placebo-controlled study Ropivacaine (n = 10) infusion significantly reduced pain compared with saline (n = 10) infusion. The average pain at rest (scale: 0-10) on postoperative day 1 ( ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818015000628

The effect of continuous interscalene brachial plexus block ... This study showed no difference in pain control or respiratory function between interscalene CPNBH with 0.125% bupivacaine and 0.2% ropivacaine. These are the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10850117/

The effect of continuous interscalene brachial plexus block for ... The continuous interscalene block with ultrasound guidance in ARCR effectively relieved pain. The recovery of ROM for extension and the strength of the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0007091217542105

Should continuous rather than single-injection interscalene ... High-level evidence indicates that CISB provides superior analgesia up to 48 h after major shoulder surgery, without increasing side-effects, compared with SISB ...

5. ekja.org ekja.org/journal/view.php?number=6965

A clinical comparison of continuous interscalene brachial ... A continuous interscalene brachial plexus block is a highly effective postoperative analgesic modality after shoulder surgery.

6. cureus.com cureus.com/articles/320042-continuous-catheter-versus-single-shot-interscalene-block-in-shoulder-surgery-a-review-and-recommendations-for-postoperative-pain-management

Continuous Catheter Versus Single-Shot Interscalene ... Single-shot ISBs provide significant immediate postoperative pain relief, whereas CISBs offer prolonged analgesia beyond 48 hours, reduced opioid consumption, ...

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Reducing rebound pain severity after arthroscopic ... Hydromorphone 2 mg given six hours after interscalene block did not reduce the severity of rebound pain postoperatively compared with placebo.

8. epain.org epain.org/journal/view.html?doi=10.3344/kjp.2015.28.3.210

Infusion Methods for Continuous Interscalene Brachial ... In this study, we confirmed that bolus-only administration of 0.2% ropivacaine 4 ml showed similar postoperative pain control and early ...