AnalgesiaNCT00923494
Effectiveness of Ultrasound (US) Guided Supraclavicular Block
A study testing 20 ml of ropivacaine 0.5%, 30 ml of ropivacaine 0.5% and 40 ml of ropivacaine 0.5% in people with Analgesia and Pain, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This research study is being done in order to find out if there is any difference in the effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- What is being tested?
- 20 ml of ropivacaine 0.5%, 30 ml of ropivacaine 0.5% and 40 ml of ropivacaine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2010
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the ages of 18-64,
- Patients who are ASA I-III, presenting for distal upper extremity surgery. Surgeries to be considered are ORIF of distal upper extremity fractures such as ORIF radius, ORIF ulna, ORIF of any bones in the wrist or hand, and distal upper extremity surgery involving bones or tendons for which postoperative pain is to be expected. No emergency surgeries will be considered.
Who cannot join
- Emergency surgery,
- Patient or surgeon refusal
- Patients for which peripheral nerve block or study medications are contraindicated,
- Patients on chronic analgesic therapy at home,
- History of nerve injury, neuropathy, or known neurologic injury or illness, or inability to properly describe postoperative pain to investigators (language barrier, psychiatric disorder, dementia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ultrasound Guided Supraclavicular Brachial Plexus Block With 20, 30, or 40 ml of Ropivacaine 0.5%
This research study is being done in order to find out if there is any difference in the effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). The investigators want to show if you can have a successful nerve block with less amount of local anesthetic, thus potentially decreasing the risk of side effects.
- Being tested
- 20 ml of ropivacaine 0.5%, 30 ml of ropivacaine 0.5%, 40 ml of ropivacaine 0.5%
- Keywords
- Anesthesia
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 ml of ropivacaine 0.5%Drug
Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
30 ml of ropivacaine 0.5%Drug
Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
40 ml of ropivacaine 0.5%Drug
Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
| Study group | Role | What they receive |
|---|---|---|
| Group R20 | Active comparator | Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block. Receives: Drug: 20 ml of ropivacaine 0.5% |
| Group R30 | Active comparator | Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block. Receives: Drug: 30 ml of ropivacaine 0.5% |
| Group R40 | Active comparator | Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block. Receives: Drug: 40 ml of ropivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of analgesia
Measured: First 30 minutes
Duration of analgesia
Measured: 24 hours
Secondary outcomes (1)
Total analgesic use
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Unable to enroll. Change in patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ortiz, Baylor College of Medicine
- Investigators
- Jaime Ortiz, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923494
- Sponsor's protocol ID
- H-24506
- Status last verified
- Jan 2017
- First submitted
- 16 Jun 2009
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound Guided Supraclavicular Brachial Plexus Block With 20, 30, or 40 ml of Ropivacaine 0.5%
- ClinicalTrials.gov ID
- NCT00923494
- Acronym / sponsor ID
- H-24506
- Keywords
- Anesthesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll. Change in patient population.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Jun 2009 (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.
This research study is being done in order to find out if there is any difference in the effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). The investigators want to show if you can have a successful nerve block with less amount of local anesthetic, thus potentially decreasing the risk of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group R20 | Active comparator | Drug: 20 ml of ropivacaine 0.5%Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block. |
| Group R30 | Active comparator | Drug: 30 ml of ropivacaine 0.5%Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block. |
| Group R40 | Active comparator | Drug: 40 ml of ropivacaine 0.5%Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients between the ages of 18-64,
- Patients who are ASA I-III, presenting for distal upper extremity surgery. Surgeries to be considered are ORIF of distal upper extremity fractures such as ORIF radius, ORIF ulna, ORIF of any bones in the wrist or hand, and distal upper extremity surgery involving bones or tendons for which postoperative pain is to be expected. No emergency surgeries will be considered.
Key exclusion criteria (5 listed)
- Emergency surgery,
- Patient or surgeon refusal
- Patients for which peripheral nerve block or study medications are contraindicated,
- Patients on chronic analgesic therapy at home,
- History of nerve injury, neuropathy, or known neurologic injury or illness, or inability to properly describe postoperative pain to investigators (language barrier, psychiatric disorder, dementia).
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 |
|---|---|---|
| 20 ml of ropivacaine 0.5%Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block. | Drug | Group R20 |
| 30 ml of ropivacaine 0.5%Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block. | Drug | Group R30 |
| 40 ml of ropivacaine 0.5%Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block. | Drug | Group R40 |
Primary outcome
Onset of analgesia
Time frame: First 30 minutes
Duration of analgesia
Time frame: 24 hours
1 secondary outcome
Total analgesic use
Time frame: First 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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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.
Jaime Ortiz, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 ml of ropivacaine 0.5%, 30 ml of ropivacaine 0.5% and 40 ml of ropivacaine 0.5% in people with Analgesia and Pain, run by Baylor College of Medicine 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: withdrawn, as of the sponsor's last update on 20 Jan 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Onset of analgesia (time frame: First 30 minutes). The study lists 2 primary outcomes in all. 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 20 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.