Carpal Tunnel SyndromeNCT01110759
Medical Review: Hand Surgery After Local Block Versus Non-block
An observational study of Carpal Tunnel Syndrome, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
In this study, the effects of local block vs non block will be assessed with respect to postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2011
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients undergoing hand surgery
Who may be able to join
- 18-80 years old
- Outpatients who underwent hand surgery under peripheral nerve block or local infiltration alone
Who cannot join
- Patients who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Retrospective Chart-review Study Involving Outpatients Who Underwent Hand Surgery With Local Anesthesia: Comparing Outcome With a Peripheral Nerve Block vs. Local Infiltration Alone
In this study, the effects of local block vs non block will be assessed with respect to postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand surgery.
Read the detailed description
Analyzing medical records and through a telephone questionnaire, in a retrospective and prospective review respectively.
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- pain management, ambulatory surgery, opioid, local anesthesia, hand surgery, postoperative pain
- Medical subject headings
- Carpal Tunnel Syndrome, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Under Local Infiltration | Not described | |
| Under Peripheral Nerve Block | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
- Severity of the pain experienced before patient left the surgery center and after patient arrived at home
- Pain medication (amounts of opioids and non opioids pills) required d)Time to suffer pain at the surgical site (hand) (days, weeks, or months)
Measured: hours to months
Secondary outcomes (2)
Nausea
- Severity of the nausea experienced by the patient.
- Medication required.
- Time to suffer nausea.
Measured: days to weeks
Vomiting
- Severity
- Medication required
- Time to suffer vomiting
Measured: dias to weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Wender, Cedars-Sinai Medical Center
- Investigators
- Ronald H Wender, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110759
- Sponsor's protocol ID
- Pro00019315
- Status last verified
- Oct 2013
- First submitted
- 23 Apr 2010
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart-review Study Involving Outpatients Who Underwent Hand Surgery With Local Anesthesia: Comparing Outcome With a Peripheral Nerve Block vs. Local Infiltration Alone
- ClinicalTrials.gov ID
- NCT01110759
- Acronym / sponsor ID
- Pro00019315
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- pain management, ambulatory surgery, opioid, local anesthesia, hand surgery, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Apr 2010 (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.
In this study, the effects of local block vs non block will be assessed with respect to postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand surgery.
Detailed description
Analyzing medical records and through a telephone questionnaire, in a retrospective and prospective review respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Under Local Infiltration | – | – |
| Under Peripheral Nerve Block | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients undergoing hand surgery
Key inclusion criteria (2 listed)
- 18-80 years old
- Outpatients who underwent hand surgery under peripheral nerve block or local infiltration alone
Key exclusion criteria (1 listed)
- Patients who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative pain
Time frame: hours to months
1. Severity of the pain experienced before patient left the surgery center and after patient arrived at home 2. Pain medication (amounts of opioids and non opioids pills) required d)Time to suffer pain at the surgical site (hand) (days, weeks, or months)
2 secondary outcomes
Nausea
Time frame: days to weeks
Vomiting
Time frame: dias to weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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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.
Ronald H Wender, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Cedars-Sinai Medical Center 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 1 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 1 Nov 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative pain (time frame: hours to months). 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 Nov 2013.