Nerve PainPhase 2DEXNCT02225054
The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery
A Phase 2 study testing Dexmedetomidine, Ropivacaine and Normal Saline in people with Nerve Pain and Shoulder Pain, run by Women's College Hospital at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Pain, Shoulder Pain
- What is being tested?
- Dexmedetomidine, Ropivacaine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Mar 2015
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral surgical shoulder procedures under general anesthetic
- English speaking patients
- ASA I-III patients
- BMI <38 kg/m2
Who cannot join
- proximal clavicular surgery
- preexisting neurological deficits or peripheral neuropathy
- known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias
- known cerebrovascular disease
- baseline heart rate <60 beats per minute or baseline systolic blood pressure <100 mm Hg
- medications that reduce heart rate (as beta-blockers, calcium blockers) known liver dysfunction or existing diseases known to cause hepatic or renal impairment
Show all 16Show fewer
- severe bronchopulmonary disease
- local infection
- contra-indication to regional anesthesia (bleeding, coagulopathy)
- chronic pain disorders
- current use of over 30mg oxycodone or equivalent per day
- contraindication to a component of multimodal analgesia
- allergy to local anesthetics or dexmedetomidine
- history of significant psychiatric conditions that may affect patient assessment
- pregnancy
- inability to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Effect of Dexmedetomidine as an Adjunct to Local Anesthetics in Ultrasound-guided Interscalene Approach to Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial
The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone.
Read the detailed description
Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and Bankart procedure generally allow the patient to go home the same day. However, post-surgical pain is often severe and it is common to encounter a delay in discharge from the hospital due to difficulty in pain control.
Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that included a significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge. Previous studies have attempted to prolong the duration of the analgesia of interscalene block by administering additional drugs to the local anesthetics but these studies have had varying degrees of success. Dexmedetomidine has recently been considered as a potentially useful drug in prolonging nerve block analgesia. Various modes of administration of Dexmedetomidine have demonstrated a consistent effect on the duration of analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and peripheral nerve blocks. When combined with local anesthetics in intravenous regional anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable of prolonging the duration of analgesia of peripheral nerve blocks.
The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in interscalene brachial plexus block.
- Conditions
- Nerve Pain, Shoulder Pain
- Being tested
- Dexmedetomidine, Ropivacaine, Normal Saline
- Keywords
- duration of analgesia
- Medical subject headings
- Neuralgia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction
RopivacaineDrug
Also called Naropin
15 ml 0.5%
Normal SalineDrug
1 mL 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine,Normal Saline,Saline Bolus | Placebo comparator | Ropivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus Receives: Drug: Ropivacaine; Drug: Normal Saline |
| Ropivacaine,Dexmedetomidine,Saline Bolus | Experimental | Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus Receives: Drug: Dexmedetomidine; Drug: Ropivacaine; Drug: Normal Saline |
| Ropivacaine,Saline,Dexmedetomidine | Active comparator | Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes Receives: Drug: Dexmedetomidine; Drug: Ropivacaine; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of interscalene nerve block.
Measured: Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.
Opioid consumption
Measured: Cumulative opioid consumption at 24 hours postoperatively
Secondary outcomes (1)
Opioid Consumption
The total amount of opioid use starting from during surgery to 14 days following surgery. Opioid side effects, patient satisfaction with pain control and the time to discharge from hospital will all be assessed Any evidence of nerve block complications at 3 months, post-block administration , will also be assessed.
Measured: Total use of opioids from the period of intra-operative to 2 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard M. Brull, MD, FRCPC, Principal investigator, University of Toronto, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225054
- Sponsor's protocol ID
- DEX-2013
- Acronym
- DEX
- Status last verified
- Nov 2017
- First submitted
- 21 Aug 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Dexmedetomidine as an Adjunct to Local Anesthetics in Ultrasound-guided Interscalene Approach to Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02225054
- Acronym / sponsor ID
- DEX / DEX-2013
- Conditions
- Nerve Pain, Shoulder Pain
- Keywords
- duration of analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Aug 2014 (estimated)
- 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.
The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone.
Detailed description
Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and Bankart procedure generally allow the patient to go home the same day. However, post-surgical pain is often severe and it is common to encounter a delay in discharge from the hospital due to difficulty in pain control.
Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that included a significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge. Previous studies have attempted to prolong the duration of the analgesia of interscalene block by administering additional drugs to the local anesthetics but these studies have had varying degrees of success. Dexmedetomidine has recently been considered as a potentially useful drug in prolonging nerve block analgesia. Various modes of administration of Dexmedetomidine have demonstrated a consistent effect on the duration of analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and peripheral nerve blocks. When combined with local anesthetics in intravenous regional anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable of prolonging the duration of analgesia of peripheral nerve blocks.
The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in interscalene brachial plexus block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine,Normal Saline,Saline Bolus | Placebo comparator | Drug: Ropivacaine, Drug: Normal SalineRopivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus |
| Ropivacaine,Dexmedetomidine,Saline Bolus | Experimental | Drug: Dexmedetomidine, Drug: Ropivacaine, Drug: Normal SalineRopivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus |
| Ropivacaine,Saline,Dexmedetomidine | Active comparator | Drug: Dexmedetomidine, Drug: Ropivacaine, Drug: Normal SalineRopivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral surgical shoulder procedures under general anesthetic
- English speaking patients
- ASA I-III patients
- BMI <38 kg/m2
Key exclusion criteria (16 listed)
- proximal clavicular surgery
- preexisting neurological deficits or peripheral neuropathy
- known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias
- known cerebrovascular disease
- baseline heart rate <60 beats per minute or baseline systolic blood pressure <100 mm Hg
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction | Drug | Ropivacaine,Dexmedetomidine,Saline Bolus, Ropivacaine,Saline,Dexmedetomidine |
| RopivacaineAlso: Naropin15 ml 0.5% | Drug | Ropivacaine,Dexmedetomidine,Saline Bolus, Ropivacaine,Normal Saline,Saline Bolus, Ropivacaine,Saline,Dexmedetomidine |
| Normal Saline1 mL 0.9% | Drug | Ropivacaine,Dexmedetomidine,Saline Bolus, Ropivacaine,Normal Saline,Saline Bolus, Ropivacaine,Saline,Dexmedetomidine |
Primary outcome
Duration of interscalene nerve block.
Time frame: Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.
Opioid consumption
Time frame: Cumulative opioid consumption at 24 hours postoperatively
1 secondary outcome
Opioid Consumption
Time frame: Total use of opioids from the period of intra-operative to 2 weeks post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Related trials for Nerve Pain
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
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.
Richard M. Brull, MD, FRCPC principal investigator
University of Toronto, Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine, Ropivacaine and Normal Saline in people with Nerve Pain and Shoulder Pain, run by Women's College Hospital 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 16 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: finished, as of the sponsor's last update on 6 Nov 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of interscalene nerve block. (time frame: Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.). The study lists 2 primary outcomes in all. 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 6 Nov 2017.