Shoulder InjuryPhase 4NCT01450007
Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery
A Phase 4 study testing Ropivacaine, Dexamethasone and Normal saline in people with Shoulder Injury, run by Mayo Clinic at 1 site in United States.
Trial summary
Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injury
- What is being tested?
- Ropivacaine, Dexamethasone and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 undergoing elective shoulder surgery by one of two surgeons highly experienced in the procedure.
- Patients are either: Opioid naïve; or Have not taken opiates for one month prior to surgery (tramadol is permissible).
- Patients have an American Society of Anesthesiology physical status I-III.
Who cannot join
- Females who are pregnant.
- Patients who are taking chronic daily opiates for one month prior to surgery except tramadol.
- Diabetic patients.
- Patients with creatinine above 1.1mg/dL for females and above 1.3mg/dL for males.
- Patients with contralateral pneumothorax or diaphragmatic paralysis.
- Patients with coagulopathy.
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- Patients with clinically significant previous nerve injury in surgical extremity.
- Patients with an allergy to NSAIDs.
- Patients who are refusing a block.
- Patients with a contraindication to ropivacaine, dexamethasone, or interscalene block due to other medical condition such as severe chronic obstructive pulmonary disease (COPD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair
Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.
- Conditions
- Shoulder Injury
- Being tested
- Ropivacaine, Dexamethasone, Normal saline
- Keywords
- Pain blockade, Ropivacaine, Dexamethasone
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
25 ml ropivacaine 0.5%
DexamethasoneDrug
8 mg dexamethasone (perineural)
DexamethasoneDrug
8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous)
Normal salineDrug
5 ml normal saline (intravenous)
Normal salineDrug
0.8 ml normal saline (perineural)
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone block | Experimental | Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline Receives: Drug: Ropivacaine; Drug: Dexamethasone; Drug: Normal saline |
| Dexamethasone IV | Active comparator | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml Receives: Drug: Ropivacaine; Drug: Dexamethasone; Drug: Normal saline |
| Placebo | Placebo comparator | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline Receives: Drug: Ropivacaine; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Sensory Blockade
Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.
Measured: Within 48 hours
Secondary outcomes (3)
Post Operative Opioid Dose at 24 Hours
Measured: approximately 24 hours after surgery
Time Until First Dose of Analgesic
Measured: Approximately 10 hours after surgery
Patient Satisfaction With Pain Control
Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.
Measured: 24 hours, 48 hours, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rosenfeld, Mayo Clinic
- Investigators
- David Rosenfeld, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450007
- Sponsor's protocol ID
- 11-001266
- Status last verified
- May 2016
- First submitted
- 7 Oct 2011
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rosenfeld DM, Ivancic MG, Hattrup SJ, Renfree KJ, Watkins AR, Hentz JG, Gorlin AW, Spiro JA, Trentman TL. Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. Anaesthesia. 2016 Apr;71(4):380-8. doi: 10.1111/anae.13409. Epub 2016 Feb 22.
PubMed 26899862
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT01450007
- Acronym / sponsor ID
- 11-001266
- Conditions
- Shoulder Injury
- Keywords
- Pain blockade, Ropivacaine, Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Posted 17 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone block | Experimental | Drug: Ropivacaine, Drug: Dexamethasone, Drug: Normal salineBlockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline |
| Dexamethasone IV | Active comparator | Drug: Ropivacaine, Drug: Dexamethasone, Drug: Normal salineBlockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml |
| Placebo | Placebo comparator | Drug: Ropivacaine, Drug: Normal salineBlockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline |
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 undergoing elective shoulder surgery by one of two surgeons highly experienced in the procedure.
- Patients are either: Opioid naïve; or Have not taken opiates for one month prior to surgery (tramadol is permissible).
- Patients have an American Society of Anesthesiology physical status I-III.
Key exclusion criteria (10 listed)
- Females who are pregnant.
- Patients who are taking chronic daily opiates for one month prior to surgery except tramadol.
- Diabetic patients.
- Patients with creatinine above 1.1mg/dL for females and above 1.3mg/dL for males.
- Patients with contralateral pneumothorax or diaphragmatic paralysis.
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 |
|---|---|---|
| RopivacaineAlso: Naropin25 ml ropivacaine 0.5% | Drug | Dexamethasone IV, Dexamethasone block, Placebo |
| Dexamethasone8 mg dexamethasone (perineural) | Drug | Dexamethasone block |
| Dexamethasone8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous) | Drug | Dexamethasone IV |
| Normal saline5 ml normal saline (intravenous) | Drug | Dexamethasone block, Placebo |
| Normal saline0.8 ml normal saline (perineural) | Drug | Dexamethasone IV, Placebo |
Primary outcome
Duration of Sensory Blockade
Time frame: Within 48 hours
Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.
3 secondary outcomes
Post Operative Opioid Dose at 24 Hours
Time frame: approximately 24 hours after surgery
Time Until First Dose of Analgesic
Time frame: Approximately 10 hours after surgery
Patient Satisfaction With Pain Control
Time frame: 24 hours, 48 hours, 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26899862Rosenfeld DM, Ivancic MG, Hattrup SJ, Renfree KJ, Watkins AR, Hentz JG, Gorlin AW, Spiro JA, Trentman TL. Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. Anaesthesia. 2016 Apr;71(4):380-8. doi: 10.1111/anae.13409. Epub 2016 Feb 22.
- 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. This study is not recruiting at the moment.
David Rosenfeld, MD principal investigator
Mayo Clinic
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 Ropivacaine, Dexamethasone and Normal saline in people with Shoulder Injury, run by Mayo Clinic 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 10 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 17 Jun 2016. 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. 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 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?
Yes. Results are posted in the registry (first posted 17 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Sensory Blockade (time frame: Within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450007, which also lists 1 linked publication.
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 17 Jun 2016.