Anesthesia, LocalNCT00801138
The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine
A study testing saline, Dexamethasone and ropivacaine in people with Anesthesia, Local and Shoulder Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Local, Shoulder Surgery
- What is being tested?
- saline, Dexamethasone and ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2010
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Patients undergoing shoulder procedures, such as rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression
Who cannot join
- Contraindications to interscalene block (Coagulopathy, infection at the needle insertion site, moderate to severe chronic obstructive pulmonary disease, contralateral pneumothorax or diaphragmatic paralysis)
- Pregnancy
- Pre-existing neuropathy involving the surgical limb
- Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery
- Chronic opioid use (greater than 30 mg oral oxycodone equivalent per day)
Trial locations and contacts
1 site in 1 country.
About this study
This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.
Read the detailed description
This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups:
- Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block;
- Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo);
- Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic;
- Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic.
The primary outcome is the duration of the interscalene nerve block which is time to first analgesic request after PACU discharge.
Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.
- Conditions
- Anesthesia, Local, Shoulder Surgery
- Being tested
- saline, Dexamethasone, ropivacaine, Bupivacaine
- Keywords
- ropivacaine, bupivacaine, glucocorticoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
2 ml 0.9% saline (placebo)
DexamethasoneDrug
dexamethasone 8 mg (2 ml)
ropivacaineDrug
30 ml 0.5% ropivacaine
BupivacaineDrug
30 ml 0.5% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block Receives: Drug: saline; Drug: ropivacaine |
| Group 2 | Placebo comparator | Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline Receives: Drug: saline; Drug: Bupivacaine |
| Group 3 | Active comparator | Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml) Receives: Drug: Dexamethasone; Drug: ropivacaine |
| Group 4 | Active comparator | Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml). Receives: Drug: Dexamethasone; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block
Measured: Postoperative day 1, 2 and 3
Secondary outcomes (3)
Time to First Report of Pain
Measured: Postoperative day 1, 2 and 3
Median Maximum VAS Pain Scores at Rest
Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicates"no pain at all" and ten indicates "worst pain imaginable." , The higher of the score, the worse of the pain.
Measured: Postoperative day 1, 2 and 3
Total Three-day Opioid Consumption in Oral Oxycodone Equivalent
Measured: Postoperative day 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: A strong primary outcome crosses the efficacy boundary at the interim analysis
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.
- Other trials for Anesthesia, LocalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Cummings, MD, Principal investigator, The Cleveland ClinicDaniel I Sessler, MD, Study chair, The Cleveland ClinicIvan Parra Sanchez, MD, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801138
- Sponsor's protocol ID
- 08-647
- Status last verified
- Mar 2017
- First submitted
- 2 Dec 2008
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine
- ClinicalTrials.gov ID
- NCT00801138
- Acronym / sponsor ID
- 08-647
- Conditions
- Anesthesia, Local, Shoulder Surgery
- Keywords
- ropivacaine, bupivacaine, glucocorticoid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A strong primary outcome crosses the efficacy boundary at the interim analysis
- Enrolment
- 218 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Posted 1 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.
Detailed description
This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups:
- Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block;
- Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo);
- Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic;
- Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic.
The primary outcome is the duration of the interscalene nerve block which is time to first analgesic request after PACU discharge.
Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: saline, Drug: ropivacaineGroup 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block |
| Group 2 | Placebo comparator | Drug: saline, Drug: BupivacaineGroup 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline |
| Group 3 | Active comparator | Drug: Dexamethasone, Drug: ropivacaineGroup 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml) |
| Group 4 | Active comparator | Drug: Dexamethasone, Drug: BupivacaineGroup 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 75 years
- Patients undergoing shoulder procedures, such as rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression
Key exclusion criteria (5 listed)
- Contraindications to interscalene block (Coagulopathy, infection at the needle insertion site, moderate to severe chronic obstructive pulmonary disease, contralateral pneumothorax or diaphragmatic paralysis)
- Pregnancy
- Pre-existing neuropathy involving the surgical limb
- Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery
- Chronic opioid use (greater than 30 mg oral oxycodone equivalent per day)
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 |
|---|---|---|
| saline2 ml 0.9% saline (placebo) | Drug | Group 1, Group 2 |
| Dexamethasonedexamethasone 8 mg (2 ml) | Drug | Group 3, Group 4 |
| ropivacaine30 ml 0.5% ropivacaine | Drug | Group 1, Group 3 |
| Bupivacaine30 ml 0.5% bupivacaine | Drug | Group 2, Group 4 |
Primary outcome
The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block
Time frame: Postoperative day 1, 2 and 3
3 secondary outcomes
Time to First Report of Pain
Time frame: Postoperative day 1, 2 and 3
Median Maximum VAS Pain Scores at Rest
Time frame: Postoperative day 1, 2 and 3
Total Three-day Opioid Consumption in Oral Oxycodone Equivalent
Time frame: Postoperative day 1, 2 and 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kenneth Cummings, MD principal investigator
The Cleveland Clinic
Daniel I Sessler, MD study chair
The Cleveland Clinic
Ivan Parra Sanchez, MD study director
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 saline, Dexamethasone and ropivacaine in people with Anesthesia, Local and Shoulder Surgery, 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 2 inclusion and 5 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 1 May 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 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?
Yes. Results are posted in the registry (first posted 1 May 2017). 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?
The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block (time frame: Postoperative day 1, 2 and 3). 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 1 May 2017.