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

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?

Continuous interscalene brachial plexus block is effective for pain relief after shoulder surgery, and adding dexmedetomidine can prolong the duration of pain relief. Ropivacaine is effective in blocking pain with potentially fewer respiratory side effects compared to other anesthetics. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{1 2 7 8 9}

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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 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]

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 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]

References

1. Korea (South) 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. [2021]

2. England 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. [2019]

3. Singapore pubmed.ncbi.nlm.nih.gov

Postoperative continuous interscalene brachial plexus blockade for hand surgery. [2020]

4. England 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. [2023]

5. United States 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. [2018]

6. India 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. [2022]

7. England 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. [2023]

8. Switzerland 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. [2023]

9. India 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. [2022]