Pain, PostoperativePhase 4NCT05824832
Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery
A Phase 4 study testing Interscalene block with the addition of buprenorphine, clonidine, dexamethasone and Interscalene block with buprenorphine alone in people with Pain, Postoperative, run by Loyola University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. The main question it aims to answer is whether there is a difference between Interscalene brachial plexus blocks with the addition of buprenorphine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Interscalene block with the addition of buprenorphine, clonidine, dexamethasone and Interscalene block with buprenorphine alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old
- Patients undergoing shoulder arthroscopy
- Patients willing to participate and sign informed consent
Who cannot join
- Severe COPD/other contraindication to general anesthesia
- Patient with a weight of less than 60 kg
- Dementia, not alert or oriented to person, place, or time
- Chronic pain patient with daily opioid use at home.
- Patient with allergy to local anesthetics
- Patient refusal
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- Total shoulder arthroplasty
- Concomitant pain in different area from operative site.
- Pregnancy
- Patient with active infection on the injection sites for the blocks
- Patients unable or willing to understand or comply with the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loyola University Chicago
Maywood, Illinois, 60153
Susan Fargo, 708-216-8046, sfargo@luc.edu
Audrice Francois, MD
About this study
Official title: Effects of a Triple Adjuvant Combination of Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery, a Prospective, Randomized Clinical Trial
The goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. The main question it aims to answer is whether there is a difference between Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.
Read the detailed description
This study will be a prospective randomized single-blinded clinical trial.
Patients undergoing shoulder arthroscopy who meet the inclusion criteria will be invited to participate in this study. A total of 120 patients will be recruited to participate.
Patients will be randomized via a 1:1 ratio to either the Interscalene block with the addition of buprenorphine, clonidine, dexamethasone group or Interscalene block alone group
The null hypothesis of this research study is that there will be no significant difference in morphine requirements between the Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.
- Conditions
- Pain, Postoperative
- Being tested
- Interscalene block with the addition of buprenorphine, clonidine, dexamethasone, Interscalene block with buprenorphine alone
- Keywords
- buprenorphine, clonidine, dexamethasone, brachial plexus blocks, pain, shoulder, surgery
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene block with the addition of buprenorphine, clonidine, dexamethasoneDrug
Also called Nerve block with buprenorphine, clonidine, dexamethasone
Addition of the adjuvant buprenorphine, dexamethasone, and clonidine in the nerve block performed prior to shoulder arthroscopy surgery
Interscalene block with buprenorphine aloneDrug
Also called Nerve block with buprenorphine alone
Addition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery
| Study group | Role | What they receive |
|---|---|---|
| Interscalene block with the addition of buprenorphine, clonidine, dexamethasone | Experimental | Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane, 30mL of 0.5% bupivacaine with 100 mcg clonidine, 0.3 mg buprenorphine, and 4 mg dexamethasone will be injected. Receives: Drug: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone |
| Interscalene block with buprenorphine alone | Active comparator | Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane 30mL of 0.5% bupivacaine will be injected. Receives: Drug: Interscalene block with buprenorphine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine requirement post surgery
To compare the morphine equivalents administered in the first 24 hours after arrival in the recovery area between the two groups.
Measured: 24 hours
Secondary outcomes (1)
Pain reported via a numeric rating scale (NRS)
To measure pain via a numeric rating scale (NRS) immediately after arrival to recovery area from surgery (time: 0hr), and again at 2, 24, and 48 hours.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start28 Feb 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized single-blinded clinical trial. 1:1 Randomization with 2 groups. Group 1: 50% of participants will receive an Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine during surgery. Group 2: 50% of participants will receive an Interscalene block alone during surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrice Francois, MD, FASA, Loyola University
- Investigators
- Audrice Francois, MD, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824832
- Sponsor's protocol ID
- 216009
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Triple Adjuvant Combination of Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery, a Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05824832
- Acronym / sponsor ID
- 216009
- Conditions
- Pain, Postoperative
- Keywords
- buprenorphine, clonidine, dexamethasone, brachial plexus blocks, pain, shoulder, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Apr 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.
The goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. The main question it aims to answer is whether there is a difference between Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.
Detailed description
This study will be a prospective randomized single-blinded clinical trial.
Patients undergoing shoulder arthroscopy who meet the inclusion criteria will be invited to participate in this study. A total of 120 patients will be recruited to participate.
Patients will be randomized via a 1:1 ratio to either the Interscalene block with the addition of buprenorphine, clonidine, dexamethasone group or Interscalene block alone group
The null hypothesis of this research study is that there will be no significant difference in morphine requirements between the Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomized single-blinded clinical trial. 1:1 Randomization with 2 groups. Group 1: 50% of participants will receive an Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine during surgery. Group 2: 50% of participants will receive an Interscalene block alone during surgery.
| Arm | Type | Receives |
|---|---|---|
| Interscalene block with the addition of buprenorphine, clonidine, dexamethasone | Experimental | Drug: Interscalene block with the addition of buprenorphine, clonidine, dexamethasoneInterscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane, 30mL of 0.5% bupivacaine with 100 mcg clonidine, 0.3 mg buprenorphine, and 4 mg dexamethasone will be injected. |
| Interscalene block with buprenorphine alone | Active comparator | Drug: Interscalene block with buprenorphine aloneInterscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane 30mL of 0.5% bupivacaine will be injected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years old
- Patients undergoing shoulder arthroscopy
- Patients willing to participate and sign informed consent
Key exclusion criteria (11 listed)
- Severe COPD/other contraindication to general anesthesia
- Patient with a weight of less than 60 kg
- Dementia, not alert or oriented to person, place, or time
- Chronic pain patient with daily opioid use at home.
- Patient with allergy to local anesthetics
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 |
|---|---|---|
| Interscalene block with the addition of buprenorphine, clonidine, dexamethasoneAlso: Nerve block with buprenorphine, clonidine, dexamethasoneAddition of the adjuvant buprenorphine, dexamethasone, and clonidine in the nerve block performed prior to shoulder arthroscopy surgery | Drug | Interscalene block with the addition of buprenorphine, clonidine, dexamethasone |
| Interscalene block with buprenorphine aloneAlso: Nerve block with buprenorphine aloneAddition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery | Drug | Interscalene block with buprenorphine alone |
Primary outcome
Morphine requirement post surgery
Time frame: 24 hours
To compare the morphine equivalents administered in the first 24 hours after arrival in the recovery area between the two groups.
1 secondary outcome
Pain reported via a numeric rating scale (NRS)
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Audrice Francois, MD principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interscalene block with the addition of buprenorphine, clonidine, dexamethasone and Interscalene block with buprenorphine alone in people with Pain, Postoperative, run by Loyola University at 1 site in United States.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 7 Mar 2025. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Fargo (708-216-8046, sfargo@luc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine requirement post surgery (time frame: 24 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 7 Mar 2025.