AnesthesiaDEXBIBNCT05775861
Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block
A study testing single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine group and continuous interscalene brachial plexus block in people with Anesthesia and Shoulder Pain, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Shoulder Pain, Post Operative Pain
- What is being tested?
- single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine group and continuous interscalene brachial plexus block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- 23 Aug 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years old
- ASA status of I-III
- Patients undergoing elective arthroscopic ambulatory shoulder surgery
- Anticipated return home the same day (less than 12 hours in-hospital) in any operating theater of the CIUSSS.
Who cannot join
- less than 18 years old
- Patient refusal
- Pregnancy
- Patients with known allergy to local anesthetics
- Contraindication to interscalene brachial plexus nerve block or superficial cervical plexus block: coagulopathy, contralateral phrenic nerve dysfunction, infection at the puncture site, severe chronic obstructive pulmonary disease
- Technical inability to proceed with the interscalene brachial plexus nerve block
Show all 15Show fewer
- Surgery requiring general anesthesia
- Body weight less than 50 kg
- Patient with no family member or caring adult at home during the first 72h postoperative (contraindication to elastomeric pump)
- Unable to communicate with the investigators, unable to read the questionnaire, unable to keep track and notes of the medication taken at home
- Significant psychiatric or cognitive condition interfering with the ability to provide consent or assessment
- Preexisting neurologic deficits or neuropathy affecting the brachial plexus
- Any contra-indication to same-day surgery identified by the pre-operative clinic such as, but not limited to, any cognitive disorder, any physical limitation other than the one leading to surgery that might impair the patient to take care of himself/herself at home, any severe pulmonary or cardiac disorder, bleeding disorder, etc,
- Any cardiac or pulmonary condition that precludes the risk of bradycardia or hypotension such as but not limited to symptomatic coronary disease, severe aortic stenosis, moderate to severe pulmonary hypertension, congestive heart failure, second or third degree block, pre-existing bradycardia (HR lower than 50), pre-existing hypotension (SBP lower than 100 mmHg), etc.
- History of chronic pain with daily opioid use during the 3 months before surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CIUSSS de l'Est de l'Ile de Montreal
Montreal, Quebec, H1T2M4
Philippe PR Richebé, MD, PhD, 5147436558, philippe.richebe@umontreal.ca
Nadia NG Godin, RN, 5142523400 ext. 3193, ngodin.hmr@ssss.gouv.qc.ca
About this study
Official title: Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block for Elective Arthroscopic Shoulder Surgery: a Prospective Randomized Control 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.
Read the detailed description
A growing number of arthroscopic shoulder surgeries are performed in an ambulatory setting. For these patients, postoperative pain management is an important factor for analgesia and optimal rehabilitation. Peripheral nerve blocks, and more particularly the interscalene brachial plexus block (ISB), is the method of choice to provide adequate surgical conditions and satisfactory postoperative pain control for shoulder surgeries. Even before the advent of ultrasound guidance , interscalene blocks resulted in a high level of patient satisfaction, fewer post-operative complications and a reduction of hospital stay compared to general anesthesia.
Shoulder surgeries are well recognized to cause severe postoperative pain, mainly in the first 48h, and the use of a single shot interscalene block (SSISB) is limited by its duration of action, which often fails to cover the duration of postoperative analgesia beyond 24 hours.
On the other hand, ultrasound-guided continuous interscalene blocks (CISB) have shown a significant reduction of pain compared to single shot interscalene blocks. However, CISB are limited by many logistical problems which make their use difficult in most ambulatory centers. Indeed, catheter placement is often a technically challenging procedure and accidental catheter removal is a complication that limits their usefulness. However, when the necessary technical resources and medical expertise is available, CISB have been associated with a superior level of analgesia, reduction of opioid consumption, improvements in rest and dynamic pain, and lower instances of postoperative nausea and vomiting than SSISB in major shoulder surgery. A recent study has demonstrated that automated intermittent boluses did not provide better analgesia nor reduced rescue opioid consumption compared to continuous infusion of ropivacaine despite both groups describing insufficient pain relief.
The persistence of pain despite the use of SSISB or CISB has lead several anesthesia teams to use adjuvants to improve the effect and duration of analgesia. Over the years, several adjuvants have been administered to enhance the brachial plexus block onset and duration. Thus, intravenous dexamethasone administered at the time of performing ISB is widely used to improve the duration of analgesia following shoulder surgeries. In addition to the benefits already provided by the addition of intravenous dexamethasone, there is also an added value to perineural dexmedetomidine in order to accelerate the onset of motor and sensory block, extend the duration of the block and reduce the pain score 14 hours postoperatively in elective shoulder surgery.
The combination of intravenous or perineural dexmedetomidine, an α-2 adrenoceptor agonist, with ropivacaine prolongs the duration of SSISB analgesia and reduces opioid consumption postoperatively without prolonging the duration of motor blockade during outpatient shoulder surgeries. Patients undergoing elective shoulder surgery under general anesthesia with perineural dexmedetomidine added to ropivacaine for interscalene block had a faster sensory and motor block onset, an increased duration of nerve blockade and improved postoperative pain up to 14h after the block. Even when a peripheral nerve block is used as the primary anesthetic, SSISB with perineural dexmedetomidine added to ropivacaine in arthroscopic rotator cuff repair has shown lower pain and improved patient satisfaction within 48 h postoperatively. The perfect perineural dexmedetomidine dose should provide optimal analgesia with minimal side effects such as hypotension and bradycardia. Over the years, it has been used in wide-ranging doses and 2 mcg/kg seems to be the optimal dose in SSISB for arthroscopic shoulder surgery to obtain a suitable duration of analgesia. A recent meta-analysis demonstrates the safety of perineural dexmedetomidine as well as its effectiveness during brachial plexus block to accelerate the onset of action and prolong the duration of analgesia. Indeed, no neurological complications or neurotoxic symptoms were reported in patients who received perineural dexmedetomidine.
Rationale for this study:
The addition of dexmedetomidine to ropivacaine for SSIB could improve the duration of postoperative analgesia and patient satisfaction for arthroscopic shoulder surgeries without the limitations and potential complications of an CISB catheter and elastomeric pump. Moreover, the use of a catheter is a complex procedure compared to a single injection and thus limited in some centers due to logistical limitations. Therefore, SSISB with perineural dexmedetomidine could be an interesting alternative to perform shoulder surgeries in centers where the use of a continuous catheter is limited by technical, professional or financial resources. Ultimately, this improvement in postoperative analgesia could lead to early patient mobilization, better physical rehabilitation and improved patient satisfaction. This study will focus on recovery, to better understand patient outcomes and experiences as a whole, in this era of personalized medicine and patient oriented research.
Methods: A predetermined sample size of patients of more than18 years old, ASA status I-III scheduled to undergo elective minor ambulatory shoulder surgery are included. Patients with known allergy to local anesthetics, contraindication to interscalene brachial plexus nerve block or superficial cervical plexus block will be excluded. The premedication and peripheral nerve block technique will be standardized for both groups. Patients will be randomized to receive either a single shot interscalene block with 150 mg of isobaric ropivacaine 0.5% (125 mg at the interscalene brachial plexus level and 25 mg at the superficial cervical plexus) with 2 mcg/kg (IBW) of dexmedetomidine or a continuous interscalene block with an initial dose of 150 mg of isobaric ropivacaine 0.5% (125 mg at the interscalene brachial plexus level and 25 mg at the superficial cervical plexus) and an infusion using an elastomeric pump of 300 mL at a rate of 5 mL/h of isobaric ropivacaine 0.2% for 60 hours. The primary endpoint will be the Quality of Recovery (QoR-15) questionnaire at 48h. The secondary endpoints will be: QoR-15 at 24h and 72h, time before the first analgesic request, time before the end of sensory block, time before the end of motor block, patient satisfaction, total post-operative opioid consumption, major and minor complications.
Study design: Prospective, randomized controlled trial.
Subject population: Adult patients scheduled to undergo elective arthroscopic ambulatory shoulder surgery
Sample size: 96
Study duration: 12 months
Study center: CIUSSS de l'Est de l'Ile de Montréal, Montreal, QC, Canada
Adverse Events: None expected
Subvention: applications to the Canadian Society of Anesthesia as well as to the Foundation of the Association of the Anesthesiologists of Quebec and to the department of anesthesiology of the UdeM will be proposed within the coming year 2021-2022.
- Conditions
- Anesthesia, Shoulder Pain, Post Operative Pain
- Being tested
- single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine group, continuous interscalene brachial plexus block
- Keywords
- Dexmedetomidine, interscalene brachial plexus nerve blocks, Elective ambulatory minor shoulder surgery
- Medical subject headings
- Shoulder Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine groupDrug
For the single shot group with dexmedetomidine added to ropivacaine group (Group D), after local analgesia with 3 mL of 1% lidocaine, the block will be performed under ultrasound guidance using an in-plane approach with a 22 G 80-mm ultrasound needle (Pajunk SonoTAP II, Germany).
The perineural solution will be pre-mixed in a 30 mL syringe before the realization of the block.
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.
continuous interscalene brachial plexus blockDrug
The block will be performed under ultrasound guidance using an in-plane approach with a 17G Tuohy needle (Arrow FlexBlock). 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).
| Study group | Role | What they receive |
|---|---|---|
| single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine | Experimental | 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. Receives: Drug: single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine group |
| continuous interscalene brachial plexus block with ropivacaine | Active comparator | 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). Receives: Drug: continuous interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint will be the Quality of Recovery (QoR-15) questionnaire score from minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery) at 48 hours postoperative.
To compare the QoR-15 questionnaire scores at 48 hours postoperative after an elective arthroscopic ambulatory shoulder surgery done solely under interscalene block and superficial cervical plexus block with a single shot of 150 mg isobaric ropivacaine 0.5% with 2 mcg/kg (IBW) of dexmedetomidine (125 mg at the level of the interscalene brachial plexus and 25 mg at the level of the superficial cervical plexus) versus a continuous interscalene brachial plexus block with an initial dose of 150 mg of isobaric ropivacaine 0.5% (125 mg at the interscalene brachial plexus level and 25 mg at the superficial cervical plexus) and a continuous infusion using an infusion pump of 300 mL at a rate of 5 mL/h of isobaric ropivacaine 0.2% for 60 hours. Assessment will be done preoperatively and on postoperative day 1, day 2 (for the primary outcome) and also on day 3.
Measured: 72 hours
Secondary outcomes (14)
QoR-15 at 24 hours and 72 hours
To compare the Quality of Recovery-15 (QoR-15) questionnaire scores at 24 hours and 72 hours postoperative from minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Measured: 24 hours and 72 hours
Time before the first analgesic request
This is defined as the time (minutes) between the ISB and the first need for rescue analgesic.
Measured: From immediate postoperative period to 72 hours postoperative
Time before the end of sensory block
This is defined as the time (minutes) between the ISB and the time the participant felt that their shoulder sensory had return to normal.
Measured: From immediate postoperative period to 72 hours postoperative
Time before the end of motor block
This will be defined as the time (minutes) between the ISB and the time the participant regains function of the biceps strength. Biceps strength is selected in lieu of shoulder abduction, as postoperative bandaging and the sling precludes this motion.
Measured: From immediate postoperative period to 72 hours postoperative
Patient satisfaction
Patient satisfaction will be noted on a scale of 0 (poor) to 10 (excellent). Since the QoR-15 is a questionnaire comprising scales ranging from 0 to 10, we opted to assess the overall patient satisfaction on a scale of 0 to 10, 0 being completely dissatisfied and 10 being completely satisfied. We evaluate the global satisfaction on post-operative day 3 (at 72 hours postoperative).
Measured: 72 hours
Total post-operative opioid consumption
Defined as the total equivalent of oral morphine taken during the first 3 post-operative days. Opioid consumption in the PACU will also be recorded.
Measured: 72 hours
Incidence of side effects related to dexmedetomidine in PACU: hypotension
Hypotension will be defined as a mean arterial pressure (MAP) under 60 mmHg
Measured: 6 hours
Incidence of side effects related to dexmedetomidine in PACU: bradycardia.
Bradycardia will be defined as a frequency cardiac (FC) under 50 beats per minute (bpm).
Measured: 6 hours
Major and minor complications
Major complications are defined as requiring significant additional medical or surgical intervention or hospitalization. Minor complications require only observation and include: leaking catheter, early catheter withdrawal, catheter site drainage, pump leaking, hematoma, pain at the catheter site, dysphagia, hoarseness, dizziness, rash, paresthesia in the distal extremity.
Measured: 72 hours
Total time from end of surgery to obtention of discharge criterias.
Total time from end of surgery to obtention of discharge criterias.
Measured: From immediate postoperative period to 5 hours postoperative
The presence of nausea and vomiting in the PACU and during the first three post-operative days.
The presence of nausea and vomiting in the PACU and during the first three post-operative days.
Measured: 72 hours
Standardized intraoperative opioid consumption (mcg of fentanyl)
Standardized intraoperative opioid consumption (mcg of fentanyl)
Measured: Surgery period (intraoperative)
Standardized intraoperative ketamine consumption (mg)
Intraoperative ketamine in mg
Measured: Surgery period (intraoperative)
Standardized intraoperative total dose of propofol used for sedation (mg).
intraoperative total dose of propofol used for sedation (mg).
Measured: Surgery period (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start23 Aug 2022
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will be first met either at our preoperative investigation clinic or by phone in the days leading to surgery to present the project and obtain consent. Consent will be dynamic and participants will have the possibility to withdraw from the study at all times. A web-based inclusion and randomization form will be provided to the investigators. Randomization will be done in a 1:1 ratio. Envelopes will be made, one for each patient, and will contain the randomization information and in which group they are in: D in the single shot dexmedetomidine added to ropivacaine or R for the continuous interscalene brachial plexus block with ropivacaine.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariane Clairoux, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Ariane Clairoux, MD, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775861
- Sponsor's protocol ID
- 2022-2892
- Acronym
- DEXBIB
- Status last verified
- Feb 2024
- First submitted
- 3 Jan 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block for Elective Arthroscopic Shoulder Surgery: a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05775861
- Acronym / sponsor ID
- DEXBIB / 2022-2892
- Conditions
- Anesthesia, Shoulder Pain, Post Operative Pain
- Keywords
- Dexmedetomidine, interscalene brachial plexus nerve blocks, Elective ambulatory minor shoulder surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A growing number of arthroscopic shoulder surgeries are performed in an ambulatory setting. For these patients, postoperative pain management is an important factor for analgesia and optimal rehabilitation. Peripheral nerve blocks, and more particularly the interscalene brachial plexus block (ISB), is the method of choice to provide adequate surgical conditions and satisfactory postoperative pain control for shoulder surgeries. Even before the advent of ultrasound guidance , interscalene blocks resulted in a high level of patient satisfaction, fewer post-operative complications and a reduction of hospital stay compared to general anesthesia.
Shoulder surgeries are well recognized to cause severe postoperative pain, mainly in the first 48h, and the use of a single shot interscalene block (SSISB) is limited by its duration of action, which often fails to cover the duration of postoperative analgesia beyond 24 hours.
On the other hand, ultrasound-guided continuous interscalene blocks (CISB) have shown a significant reduction of pain compared to single shot interscalene blocks. However, CISB are limited by many logistical problems which make their use difficult in most ambulatory centers. Indeed, catheter placement is often a technically challenging procedure and accidental catheter removal is a complication that limits their usefulness. However, when the necessary technical resources and medical expertise is available, CISB have been associated with a superior level of analgesia, reduction of opioid consumption, improvements in rest and dynamic pain, and lower instances of postoperative nausea and vomiting than SSISB in major shoulder surgery. A recent study has demonstrated that automated intermittent boluses did not provide better analgesia nor reduced rescue opioid consumption compared to continuous infusion of ropivacaine despite both groups describing insufficient pain relief.
The persistence of pain despite the use of SSISB or CISB has lead several anesthesia teams to use adjuvants to improve the effect and duration of analgesia. Over the years, several adjuvants have been administered to enhance the brachial plexus block onset and duration. Thus, intravenous dexamethasone administered at the time of performing ISB is widely used to improve the duration of analgesia following shoulder surgeries. In addition to the benefits already provided by the addition of intravenous dexamethasone, there is also an added value to perineural dexmedetomidine in order to accelerate the onset of motor and sensory block, extend the duration of the block and reduce the pain score 14 hours postoperatively in elective shoulder surgery.
The combination of intravenous or perineural dexmedetomidine, an α-2 adrenoceptor agonist, with ropivacaine prolongs the duration of SSISB analgesia and reduces opioid consumption postoperatively without prolonging the duration of motor blockade during outpatient shoulder surgeries. Patients undergoing elective shoulder surgery under general anesthesia with perineural dexmedetomidine added to ropivacaine for interscalene block had a faster sensory and motor block onset, an increased duration of nerve blockade and improved postoperative pain up to 14h after the block. Even when a peripheral nerve block is used as the primary anesthetic, SSISB with perineural dexmedetomidine added to ropivacaine in arthroscopic rotator cuff repair has shown lower pain and improved patient satisfaction within 48 h postoperatively. The perfect perineural dexmedetomidine dose should provide optimal analgesia with minimal side effects such as hypotension and bradycardia. Over the years, it has been used in wide-ranging doses and 2 mcg/kg seems to be the optimal dose in SSISB for arthroscopic shoulder surgery to obtain a suitable duration of analgesia. A recent meta-analysis demonstrates the safety of perineural dexmedetomidine as well as its effectiveness during brachial plexus block to accelerate the onset of action and prolong the duration of analgesia. Indeed, no neurological complications or neurotoxic symptoms were reported in patients who received perineural dexmedetomidine.
Rationale for this study:
The addition of dexmedetomidine to ropivacaine for SSIB could improve the duration of postoperative analgesia and patient satisfaction for arthroscopic shoulder surgeries without the limitations and potential complications of an CISB catheter and elastomeric pump. Moreover, the use of a catheter is a complex procedure compared to a single injection and thus limited in some centers due to logistical limitations. Therefore, SSISB with perineural dexmedetomidine could be an interesting alternative to perform shoulder surgeries in centers where the use of a continuous catheter is limited by technical, professional or financial resources. Ultimately, this improvement in postoperative analgesia could lead to early patient mobilization, better physical rehabilitation and improved patient satisfaction. This study will focus on recovery, to better understand patient outcomes and experiences as a whole, in this era of personalized medicine and patient oriented research.
Methods: A predetermined sample size of patients of more than18 years old, ASA status I-III scheduled to undergo elective minor ambulatory shoulder surgery are included. Patients with known allergy to local anesthetics, contraindication to interscalene brachial plexus nerve block or superficial cervical plexus block will be excluded. The premedication and peripheral nerve block technique will be standardized for both groups. Patients will be randomized to receive either a single shot interscalene block with 150 mg of isobaric ropivacaine 0.5% (125 mg at the interscalene brachial plexus level and 25 mg at the superficial cervical plexus) with 2 mcg/kg (IBW) of dexmedetomidine or a continuous interscalene block with an initial dose of 150 mg of isobaric ropivacaine 0.5% (125 mg at the interscalene brachial plexus level and 25 mg at the superficial cervical plexus) and an infusion using an elastomeric pump of 300 mL at a rate of 5 mL/h of isobaric ropivacaine 0.2% for 60 hours. The primary endpoint will be the Quality of Recovery (QoR-15) questionnaire at 48h. The secondary endpoints will be: QoR-15 at 24h and 72h, time before the first analgesic request, time before the end of sensory block, time before the end of motor block, patient satisfaction, total post-operative opioid consumption, major and minor complications.
Study design: Prospective, randomized controlled trial.
Subject population: Adult patients scheduled to undergo elective arthroscopic ambulatory shoulder surgery
Sample size: 96
Study duration: 12 months
Study center: CIUSSS de l'Est de l'Ile de Montréal, Montreal, QC, Canada
Adverse Events: None expected
Subvention: applications to the Canadian Society of Anesthesia as well as to the Foundation of the Association of the Anesthesiologists of Quebec and to the department of anesthesiology of the UdeM will be proposed within the coming year 2021-2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients will be first met either at our preoperative investigation clinic or by phone in the days leading to surgery to present the project and obtain consent. Consent will be dynamic and participants will have the possibility to withdraw from the study at all times. A web-based inclusion and randomization form will be provided to the investigators. Randomization will be done in a 1:1 ratio. Envelopes will be made, one for each patient, and will contain the randomization information and in which group they are in: D in the single shot dexmedetomidine added to ropivacaine or R for the continuous interscalene brachial plexus block with ropivacaine.
| Arm | Type | Receives |
|---|---|---|
| single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine | Experimental | Drug: single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine groupA 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. |
| continuous interscalene brachial plexus block with ropivacaine | Active comparator | Drug: continuous interscalene brachial plexus blockA 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years old
- ASA status of I-III
- Patients undergoing elective arthroscopic ambulatory shoulder surgery
- Anticipated return home the same day (less than 12 hours in-hospital) in any operating theater of the CIUSSS.
Key exclusion criteria (15 listed)
- less than 18 years old
- Patient refusal
- Pregnancy
- Patients with known allergy to local anesthetics
- Contraindication to interscalene brachial plexus nerve block or superficial cervical plexus block: coagulopathy, contralateral phrenic nerve dysfunction, infection at the puncture site, severe chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine groupFor the single shot group with dexmedetomidine added to ropivacaine group (Group D), after local analgesia with 3 mL of 1% lidocaine, the block will be performed under ultrasound guidance using an in-plane approach with a 22 G 80-mm ultrasound needle (Pajunk SonoTAP II, Germany). The perineural solution will be pre-mixed in a 30 mL syringe before the realization of the block. 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. | Drug | single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine |
| continuous interscalene brachial plexus blockThe block will be performed under ultrasound guidance using an in-plane approach with a 17G Tuohy needle (Arrow FlexBlock). 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). | Drug | continuous interscalene brachial plexus block with ropivacaine |
Primary outcome
Primary endpoint will be the Quality of Recovery (QoR-15) questionnaire score from minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery) at 48 hours postoperative.
Time frame: 72 hours
To compare the QoR-15 questionnaire scores at 48 hours postoperative after an elective arthroscopic ambulatory shoulder surgery done solely under interscalene block and superficial cervical plexus block with a single shot of 150 mg isobaric ropivacaine 0.5% with 2 mcg/kg (IBW) of dexmedetomidine (125 mg at the level of the interscalene brachial plexus and 25 mg at the level of the superficial cervical plexus) versus a continuous interscalene brachial plexus block with an initial dose of 150 mg of isobaric ropivacaine 0.5% (125 mg at the interscalene brachial plexus level and 25 mg at the superficial cervical plexus) and a continuous infusion using an infusion pump of 300 mL at a rate of 5 mL/h of isobaric ropivacaine 0.2% for 60 hours. Assessment will be done preoperatively and on postoperative day 1, day 2 (for the primary outcome) and also on day 3.
14 secondary outcomes
QoR-15 at 24 hours and 72 hours
Time frame: 24 hours and 72 hours
Time before the first analgesic request
Time frame: From immediate postoperative period to 72 hours postoperative
Time before the end of sensory block
Time frame: From immediate postoperative period to 72 hours postoperative
Time before the end of motor block
Time frame: From immediate postoperative period to 72 hours postoperative
Patient satisfaction
Time frame: 72 hours
Total post-operative opioid consumption
Time frame: 72 hours
Incidence of side effects related to dexmedetomidine in PACU: hypotension
Time frame: 6 hours
Incidence of side effects related to dexmedetomidine in PACU: bradycardia.
Time frame: 6 hours
Major and minor complications
Time frame: 72 hours
Total time from end of surgery to obtention of discharge criterias.
Time frame: From immediate postoperative period to 5 hours postoperative
The presence of nausea and vomiting in the PACU and during the first three post-operative days.
Time frame: 72 hours
Standardized intraoperative opioid consumption (mcg of fentanyl)
Time frame: Surgery period (intraoperative)
Standardized intraoperative ketamine consumption (mg)
Time frame: Surgery period (intraoperative)
Standardized intraoperative total dose of propofol used for sedation (mg).
Time frame: Surgery period (intraoperative)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariane Clairoux, MD principal investigator
Ciusss de L'Est de l'Île de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine group and continuous interscalene brachial plexus block in people with Anesthesia and Shoulder Pain, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane AC Clairoux, MD, FRCPC (5142226743, ariane.clairoux@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint will be the Quality of Recovery (QoR-15) questionnaire score from minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery) at 48 hours postoperative. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.