Local AnestheticPhase 3NCT00825786
Ultrasound Guided Supraclavicular Nerve Block
A Phase 3 study testing Ropivacaine and Mepivacaine in people with Local Anesthetic, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Local Anesthetic
- What is being tested?
- Ropivacaine and Mepivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2010
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing upper extremity procedures suitable for supraclavicular anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery
- Age between 18 and 70 years
Who cannot join
- Contraindications to supraclavicular block
- Coagulopathy
- Infection at the needle insertion site
- Severe chronic obstructive pulmonary disease (COPD)
- Contralateral pneumothorax or diaphragmatic paralysis
- Pregnancy
Show all 9Show fewer
- Preexisting neuropathy involving the surgical limb
- Routine opioid use
- Inability to attain adequate ultrasound images in the supraclavicular area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine
This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.
Read the detailed description
Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine - subject will receive two injections before surgery begins. These two injections will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml).
Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two injections before surgery begins. One injection will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).
On the first, second, and third mornings after surgery,subjects will be asked to rate their pain on a scale of 1 to 10. If the subject is discharged from the hospital, a telephone call will be made to the subject's home to collect this information.
- Conditions
- Local Anesthetic
- Being tested
- Ropivacaine, Mepivacaine
- Keywords
- surgery for arm hand or elbow, mepivacaine, ropivacaine, hand surgery, elbow surgery, forearm surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
ropivacaine (15 ml).
MepivacaineDrug
One syringe will contain mepivacaine (15 ml)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Receives: Drug: Ropivacaine; Drug: Mepivacaine |
| Group 2 | Active comparator | sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Receives: Drug: Ropivacaine; Drug: Mepivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia.
The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.
Measured: During surgery: postoperative day 0
Secondary outcomes (6)
Time to Complete Motor Block
Measured: during surgery from induction time to end case time
Time to Onset of First Sensory Block
Measured: during surgery
Maximum Verbal Response Score (VRS) With Rest
The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain
Measured: through post operative day 3
Maximum Verbal Response Score (VRS) With Movement
The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst
Measured: through post operative day 3
Duration of Analgesia
Time from the complete onset of sensory block until first request for an analgesic
Measured: from surgery date to postoperative day 1
Total Opioid Consumption
In morphine equivalent dose
Measured: postoperative day 1 to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2010
- Study completionAug 2010
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 Local AnestheticStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael R Ritchey, MD, Principal investigator, Cleveland ClinidDaniel I Sessler, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825786
- Sponsor's protocol ID
- 08-671
- Status last verified
- May 2017
- First submitted
- 16 Jan 2009
- Last updated
- 14 Jun 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 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine
- ClinicalTrials.gov ID
- NCT00825786
- Acronym / sponsor ID
- 08-671
- Conditions
- Local Anesthetic
- Keywords
- surgery for arm hand or elbow, mepivacaine, ropivacaine, hand surgery, elbow surgery, forearm surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Posted 19 Apr 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 sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.
Detailed description
Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine - subject will receive two injections before surgery begins. These two injections will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml).
Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two injections before surgery begins. One injection will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).
On the first, second, and third mornings after surgery,subjects will be asked to rate their pain on a scale of 1 to 10. If the subject is discharged from the hospital, a telephone call will be made to the subject's home to collect this information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Ropivacaine, Drug: Mepivacainecombined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; |
| Group 2 | Active comparator | Drug: Ropivacaine, Drug: Mepivacainesequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing upper extremity procedures suitable for supraclavicular anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery
- Age between 18 and 70 years
Key exclusion criteria (9 listed)
- Contraindications to supraclavicular block
- Pregnancy
- Preexisting neuropathy involving the surgical limb
- Routine opioid use
- Inability to attain adequate ultrasound images in the supraclavicular area
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 |
|---|---|---|
| Ropivacaineropivacaine (15 ml). | Drug | Group 1, Group 2 |
| MepivacaineOne syringe will contain mepivacaine (15 ml) | Drug | Group 1, Group 2 |
Primary outcome
Duration of Analgesia.
Time frame: During surgery: postoperative day 0
The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.
6 secondary outcomes
Time to Complete Motor Block
Time frame: during surgery from induction time to end case time
Time to Onset of First Sensory Block
Time frame: during surgery
Maximum Verbal Response Score (VRS) With Rest
Time frame: through post operative day 3
Maximum Verbal Response Score (VRS) With Movement
Time frame: through post operative day 3
Duration of Analgesia
Time frame: from surgery date to postoperative day 1
Total Opioid Consumption
Time frame: postoperative day 1 to day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Local Anesthetic
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Use of a Virtual Reality Headset During Prostate Biopsy Under Local Anesthesia to Improve the Patient's Experience
Prostate Biopsy
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
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.
Michael R Ritchey, MD principal investigator
Cleveland Clinid
Daniel I Sessler, MD study chair
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 Phase 3 study testing Ropivacaine and Mepivacaine in people with Local Anesthetic, 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 9 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 14 Jun 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Apr 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?
Duration of Analgesia. (time frame: During surgery: postoperative day 0). 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 14 Jun 2017.