Duration of Interscalene BlockNCT01495624
The Effect of Systemic or Perineural Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine
A study testing ropivacaine plus dexamethasone anesthetic and ropivacaine plus saline plus dexamethasone anesthetic in people with Duration of Interscalene Block, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Patients undergoing rotator cuff repair or subacromial decompression at the investigators institution are frequently hospitalized overnight due to inadequate pain relief after resolution of interscalene brachial plexus blocks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Duration of Interscalene Block
- What is being tested?
- ropivacaine plus dexamethasone anesthetic and ropivacaine plus saline plus dexamethasone anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing shoulder procedures such as
- Rotator cuff repair
- Capsular shift
- Shoulder arthroplasty
- Subacromial decompression
- Exclusion Criteria:
Show all 15Show fewer
- Contraindications to interscalene block
- Coagulopathy
- Infection at the needle insertion site
- Moderate to severe chronic obstructive pulmonary disease (COPD)
- Contralateral pneumothorax or diaphragmatic paralysis
- Pregnancy
- Preexisting neuropathy involving the surgical limb
- Systemic glucocorticoid treatment (for at least one week) within six months of surgery
- Routine opioid use (greater than 30 mg oxycodone per day or equivalent)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Patients undergoing rotator cuff repair or subacromial decompression at the investigators institution are frequently hospitalized overnight due to inadequate pain relief after resolution of interscalene brachial plexus blocks. For ropivacaine 0.5%, the investigators usual local anesthetic, previous studies report an analgesic duration of 11.1 ± 5 hours without epinephrine and approximately 12 hours with epinephrine. Consequently, a method of prolonging analgesia from a brachial plexus block without the extra equipment and logistical difficulties of indwelling catheters would benefit both patients and caregivers. A potential approach is use of adjuvant drugs that prolong block duration when added to the local anesthetic.
In addition to the usual adjuvant anesthetic drugs, investigators have begun to evaluate glucocorticoids as adjuvants for regional anesthesia. Known for their anti-inflammatory, analgesic, immunosuppressive, and antiemetic properties, these corticosteroids exert their effects by inhibition of phospholipase A2 as well as changes in cell function induced by glucocorticoid receptor activation. Although associated with significant toxicity when administered in large doses for long periods, emerging literature suggests that a single perioperative dose of glucocorticoid is safe. Several studies, including a recent trial at the investigators institution, have demonstrated the efficacy of dexamethasone in prolonging regional anesthetics. Available data thus suggest that combining glucocorticoids with local anesthetics prolongs block duration. However, systemic glucocorticoids have also been shown to reduce postoperative pain. This raises the question whether the beneficial effects of adding glucocorticoid to a regional anesthetic is solely due to local effect or is mediated at least in part by systemic action. Previous trials, however, have not addressed this important issue. If this beneficial effect of analgesic duration is mediated by systemic action, adding dexamethasone to the local anesthetic mixture may be unnecessary. Although no study has reported neurotoxicity from perineural dexamethasone and laboratory data appear to confirm the safety of this route, achieving similar results with more conventional administration would be desirable for two reasons. First, conventional intravenous dosing is convenient, useful for other reasons (for example, postoperative nausea prophylaxis), and well-studied. Second, equivalent (or not equivalent) results from systemic dosing would provide valuable information about the mechanism behind dexamethasone's effect on block duration.
- Conditions
- Duration of Interscalene Block
- Being tested
- ropivacaine plus dexamethasone anesthetic, ropivacaine plus saline plus dexamethasone anesthetic
- Keywords
- rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression, 18 and 75 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine plus dexamethasone anestheticOther
Subjects will receive interscalen block comprised of 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo);
ropivacaine plus saline plus dexamethasone anestheticOther
Subjects will receive interscalen block with 30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine with perineural dexamethasone | Placebo comparator | 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo); Receives: Other: ropivacaine plus dexamethasone anesthetic |
| Ropivacaine with systemic steroid | Active comparator | 30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically. Receives: Other: ropivacaine plus saline plus dexamethasone anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of interscalene nerve block
The clinical duration of the interscalene nerve block, which will be measured by time from onset of sensory block until first administration of analgesic medication or requirement for initiation of the perineural catheter infusion.
Measured: Day one
Secondary outcomes (4)
increase in shoulder discomfort
time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.
Measured: as reported in minutes after procedure, day one
maximum VRS (Verbal Response Score) with rest
time to a noticeable increase in shoulder discomfort, maximum VRS (Verbal Response Score) with rest and movement, and total opioid consumption.
Measured: upon admission to PACU through post operative day 2, post operative day 14
Verbal Response Score (VRS) with movement
time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.
Measured: upon admission daily through post operative day 2, post operative day 14
total opioid consumption
time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.
Measured: daily through post operative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Accrual insufficient to complete study in a feasible time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duration of Interscalene BlockStudies of the same condition, open and under way.
- More trials run by The Cleveland 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Cummings III, MD, MS, The Cleveland Clinic
- Investigators
- Kenneth Cummings, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495624
- Sponsor's protocol ID
- 11-1048
- Status last verified
- Jan 2016
- First submitted
- 12 Dec 2011
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.
PubMed 34554686
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Systemic or Perineural Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine
- ClinicalTrials.gov ID
- NCT01495624
- Acronym / sponsor ID
- 11-1048
- Conditions
- Duration of Interscalene Block
- Keywords
- rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression, 18 and 75 years
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual insufficient to complete study in a feasible time frame
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Dec 2011 (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.
Patients undergoing rotator cuff repair or subacromial decompression at the investigators institution are frequently hospitalized overnight due to inadequate pain relief after resolution of interscalene brachial plexus blocks. For ropivacaine 0.5%, the investigators usual local anesthetic, previous studies report an analgesic duration of 11.1 ± 5 hours without epinephrine and approximately 12 hours with epinephrine. Consequently, a method of prolonging analgesia from a brachial plexus block without the extra equipment and logistical difficulties of indwelling catheters would benefit both patients and caregivers. A potential approach is use of adjuvant drugs that prolong block duration when added to the local anesthetic.
In addition to the usual adjuvant anesthetic drugs, investigators have begun to evaluate glucocorticoids as adjuvants for regional anesthesia. Known for their anti-inflammatory, analgesic, immunosuppressive, and antiemetic properties, these corticosteroids exert their effects by inhibition of phospholipase A2 as well as changes in cell function induced by glucocorticoid receptor activation. Although associated with significant toxicity when administered in large doses for long periods, emerging literature suggests that a single perioperative dose of glucocorticoid is safe. Several studies, including a recent trial at the investigators institution, have demonstrated the efficacy of dexamethasone in prolonging regional anesthetics. Available data thus suggest that combining glucocorticoids with local anesthetics prolongs block duration. However, systemic glucocorticoids have also been shown to reduce postoperative pain. This raises the question whether the beneficial effects of adding glucocorticoid to a regional anesthetic is solely due to local effect or is mediated at least in part by systemic action. Previous trials, however, have not addressed this important issue. If this beneficial effect of analgesic duration is mediated by systemic action, adding dexamethasone to the local anesthetic mixture may be unnecessary. Although no study has reported neurotoxicity from perineural dexamethasone and laboratory data appear to confirm the safety of this route, achieving similar results with more conventional administration would be desirable for two reasons. First, conventional intravenous dosing is convenient, useful for other reasons (for example, postoperative nausea prophylaxis), and well-studied. Second, equivalent (or not equivalent) results from systemic dosing would provide valuable information about the mechanism behind dexamethasone's effect on block duration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine with perineural dexamethasone | Placebo comparator | Other: ropivacaine plus dexamethasone anesthetic30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo); |
| Ropivacaine with systemic steroid | Active comparator | Other: ropivacaine plus saline plus dexamethasone anesthetic30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients undergoing shoulder procedures such as
- Rotator cuff repair
- Capsular shift
- Shoulder arthroplasty
- Subacromial decompression
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ropivacaine plus dexamethasone anestheticSubjects will receive interscalen block comprised of 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo); | Other | Ropivacaine with perineural dexamethasone |
| ropivacaine plus saline plus dexamethasone anestheticSubjects will receive interscalen block with 30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically. | Other | Ropivacaine with systemic steroid |
Primary outcome
duration of interscalene nerve block
Time frame: Day one
The clinical duration of the interscalene nerve block, which will be measured by time from onset of sensory block until first administration of analgesic medication or requirement for initiation of the perineural catheter infusion.
4 secondary outcomes
increase in shoulder discomfort
Time frame: as reported in minutes after procedure, day one
maximum VRS (Verbal Response Score) with rest
Time frame: upon admission to PACU through post operative day 2, post operative day 14
Verbal Response Score (VRS) with movement
Time frame: upon admission daily through post operative day 2, post operative day 14
total opioid consumption
Time frame: daily through post operative day 2
Results and safety
The study was stopped early (reason given: Accrual insufficient to complete study in a feasible time frame). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Derived from this study: PubMed 34554686Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.
Related trials for Duration of Interscalene Block
Enrolling by invitationObservational study
The Effect of Anthropometric Measurements on Block Success, Performance Time , and Ultrasound Visibility Score.
Interscalene Blocks
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.
Kenneth Cummings, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine plus dexamethasone anesthetic and ropivacaine plus saline plus dexamethasone anesthetic in people with Duration of Interscalene Block, run by The Cleveland 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 15 inclusion and 0 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: stopped early, as of the sponsor's last update on 27 Jan 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.
Are results available for this study?
The study was stopped early (reason given: Accrual insufficient to complete study in a feasible time frame). Results are not available in the source record.
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: Day one). 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 NCT01495624, 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 27 Jan 2016.