Upper Extremity SurgeryNCT02151487
A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block
An observational study of Upper Extremity Surgery, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The aim of this randomized, observer-blinded study is to evaluate the postoperative analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in supraclavicular nerve block. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Extremity Surgery
- What is being tested?
- Ropivacaine, Ropivacaine and dexamethasone and Ropivacaine and clonidine
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 20 Aug 2016
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who scheduled to undergo upper extremity surgery requiring USSB for postoperative analgesia with ropivacaine alone or ropivacaine and adjuvants.
Who may be able to join
- Men and women 18-80 years old
- Undergoing upper extremity surgery
- Receiving Supraclavicular block
- Receiving ropivacaine, ropivacaine adjuvants (dexamethasone, clonidine) for the supraclavicular nerve block.
- Able to give Informed consent
Who cannot join
- Age less than 18 and greater than 80 years
- Inability to understand the study procedures
- Significant respiratory dysfunction
- Preexisting neurologic deficits
- Allergy to local anesthetics
- A bleeding diathesis or on anticoagulants
- Systemic glucocorticoid use
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health Hospital System
Dallas, Texas, 750390
About this study
Official title: A Comparison of Ropivacaine Alone Versus Ropivacaine With Dexamethasone or Clonidine Versus a Combination of Ropivacaine, Dexamethasone, and Clonidine for Supraclavicular Brachial Plexus Block Using Ultrasound:A Prospective, Observer-blinded, Randomized Study
The aim of this randomized, observer-blinded study is to evaluate the postoperative analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in supraclavicular nerve block. The investigators hypothesized that addition of dexamethasone and clonidine to ropivacaine would prolong the duration of analgesia in supraclavicular nerve block compared with ropivacaine alone.
Read the detailed description
Subjects undergoing orthopedic surgery of upper extremities were randomized to be one of the three groups to receive supraclavicular nerve block with group 1: ropivacaine alone; group 2: ropivacaine and dexamethasone; group 3: ropivacaine and clonidine or group 4: ropivacaine and dexamethasone and clonidine combination.
Subjects were identified at the day surgery unit at Parkland hospital before the procedure and approached by their physician, the primary investigator, or research personnel for the consent for the study. If the subjects chooses and consents fully to participate, he or she was randomly assigned to receive one of the previously described local anesthetics for supraclavicular nerve block.
The following clinical outcomes were assessed for up to 24 hr: Duration of the block, onset of the block, postoperative pain scores, nausea, vomiting, and complications of peripheral nerve block. Pain was evaluated by using a linear 10-cm visual analog scale (VAS; 0=no pain, 10= worst imaginable pain) immediately before the block, 5, 10, 15 minutes and postoperatively on the arrival of Post Anesthesia Care Unit (PACU) within 15 minutes, discharge from the Day surgery Unit, and 24 hr. later at home via phone call visit.
Sensory and motor block in the related nerve dermatomes were assessed. Patient was instructed to document at what time did hand motion (finger movement) return and what time normal sensation return. Specific time for both events was sked to patient at phone call visit 24 hr later. Overall patient satisfaction was evaluated at the discharge from the day surgery and 24 hr after the block via phone visit.
At any point in which the patient is not experiencing pain relief after having received the injection, they were removed from the study and other anesthetic techniques will be applied to resolve their pain along with pharmacological management of their pain. Rescue antiemetic, which is standard of care, will be given to any patient who complains of nausea or vomiting.
- Conditions
- Upper Extremity Surgery
- Being tested
- Ropivacaine, Ropivacaine and dexamethasone, Ropivacaine and clonidine, Ropivacaine, dexamethasone and clonidine
- Keywords
- Supraclavicular block, Ropivacaine, Dexamethasone, Clonidine, Postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Noropin
Ropivacaine alone
Ropivacaine and dexamethasoneDrug
Also called Noropin and adjuvant
Ropivacaine combination with dexamethasone
Ropivacaine and clonidineDrug
Also called Noropin and adjuvants
Ropivacaine combination with clonidine
Ropivacaine, dexamethasone and clonidineDrug
Also called Noropin and adjuvants
Ropivacaine combination with dexamethasone and clonidine
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Ropivacaine 0.5% 25 ml alone for supraclavicular block Receives: Drug: Ropivacaine | |
| Ropivacaine and dexamethasone | 25 ml 0.5% ropivacaine + 4 mg dexamethasone Receives: Drug: Ropivacaine and dexamethasone | |
| Ropivacaine and clonidine | 25 ml 0.5% ropivacaine + 100 mcg clonidine Receives: Drug: Ropivacaine and clonidine | |
| Ropivacaine, dexamethasone and clonidine | 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine Receives: Drug: Ropivacaine, dexamethasone and clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the Sensorial Supraclavicular Block
Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home
Measured: within 24-hr after surgery
Secondary outcomes (1)
Postoperative Analgesia
Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain).
Measured: within 15 minutes at postanesthesia care unit (PACU) arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completion20 Aug 2016
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 Upper Extremity SurgeryStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern 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
- Other
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawood Nasir, University of Texas Southwestern Medical Center
- Investigators
- Dawood Nasir, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151487
- Sponsor's protocol ID
- 102013-068
- Status last verified
- Apr 2019
- First submitted
- 28 May 2014
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Ropivacaine Alone Versus Ropivacaine With Dexamethasone or Clonidine Versus a Combination of Ropivacaine, Dexamethasone, and Clonidine for Supraclavicular Brachial Plexus Block Using Ultrasound:A Prospective, Observer-blinded, Randomized Study
- ClinicalTrials.gov ID
- NCT02151487
- Acronym / sponsor ID
- 102013-068
- Conditions
- Upper Extremity Surgery
- Keywords
- Supraclavicular block, Ropivacaine, Dexamethasone, Clonidine, Postoperative analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- 20 Aug 2016 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized, observer-blinded study is to evaluate the postoperative analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in supraclavicular nerve block. The investigators hypothesized that addition of dexamethasone and clonidine to ropivacaine would prolong the duration of analgesia in supraclavicular nerve block compared with ropivacaine alone.
Detailed description
Subjects undergoing orthopedic surgery of upper extremities were randomized to be one of the three groups to receive supraclavicular nerve block with group 1: ropivacaine alone; group 2: ropivacaine and dexamethasone; group 3: ropivacaine and clonidine or group 4: ropivacaine and dexamethasone and clonidine combination.
Subjects were identified at the day surgery unit at Parkland hospital before the procedure and approached by their physician, the primary investigator, or research personnel for the consent for the study. If the subjects chooses and consents fully to participate, he or she was randomly assigned to receive one of the previously described local anesthetics for supraclavicular nerve block.
The following clinical outcomes were assessed for up to 24 hr: Duration of the block, onset of the block, postoperative pain scores, nausea, vomiting, and complications of peripheral nerve block. Pain was evaluated by using a linear 10-cm visual analog scale (VAS; 0=no pain, 10= worst imaginable pain) immediately before the block, 5, 10, 15 minutes and postoperatively on the arrival of Post Anesthesia Care Unit (PACU) within 15 minutes, discharge from the Day surgery Unit, and 24 hr. later at home via phone call visit.
Sensory and motor block in the related nerve dermatomes were assessed. Patient was instructed to document at what time did hand motion (finger movement) return and what time normal sensation return. Specific time for both events was sked to patient at phone call visit 24 hr later. Overall patient satisfaction was evaluated at the discharge from the day surgery and 24 hr after the block via phone visit.
At any point in which the patient is not experiencing pain relief after having received the injection, they were removed from the study and other anesthetic techniques will be applied to resolve their pain along with pharmacological management of their pain. Rescue antiemetic, which is standard of care, will be given to any patient who complains of nausea or vomiting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | – | Drug: RopivacaineRopivacaine 0.5% 25 ml alone for supraclavicular block |
| Ropivacaine and dexamethasone | – | Drug: Ropivacaine and dexamethasone25 ml 0.5% ropivacaine + 4 mg dexamethasone |
| Ropivacaine and clonidine | – | Drug: Ropivacaine and clonidine25 ml 0.5% ropivacaine + 100 mcg clonidine |
| Ropivacaine, dexamethasone and clonidine | – | Drug: Ropivacaine, dexamethasone and clonidine25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who scheduled to undergo upper extremity surgery requiring USSB for postoperative analgesia with ropivacaine alone or ropivacaine and adjuvants.
Key inclusion criteria (5 listed)
- Men and women 18-80 years old
- Undergoing upper extremity surgery
- Receiving Supraclavicular block
- Receiving ropivacaine, ropivacaine adjuvants (dexamethasone, clonidine) for the supraclavicular nerve block.
- Able to give Informed consent
Key exclusion criteria (8 listed)
- Age less than 18 and greater than 80 years
- Inability to understand the study procedures
- Significant respiratory dysfunction
- Preexisting neurologic deficits
- Allergy to local anesthetics
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 |
|---|---|---|
| RopivacaineAlso: NoropinRopivacaine alone | Drug | Ropivacaine |
| Ropivacaine and dexamethasoneAlso: Noropin and adjuvantRopivacaine combination with dexamethasone | Drug | Ropivacaine and dexamethasone |
| Ropivacaine and clonidineAlso: Noropin and adjuvantsRopivacaine combination with clonidine | Drug | Ropivacaine and clonidine |
| Ropivacaine, dexamethasone and clonidineAlso: Noropin and adjuvantsRopivacaine combination with dexamethasone and clonidine | Drug | Ropivacaine, dexamethasone and clonidine |
Primary outcome
Duration of the Sensorial Supraclavicular Block
Time frame: within 24-hr after surgery
Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home
1 secondary outcome
Postoperative Analgesia
Time frame: within 15 minutes at postanesthesia care unit (PACU) arrival
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- 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.
Dawood Nasir, MD principal investigator
University of Texas Southwestern 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 Upper Extremity Surgery, run by University of Texas Southwestern 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 5 inclusion and 8 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 5 Jul 2019. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2019). 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 the Sensorial Supraclavicular Block (time frame: within 24-hr after surgery). 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 5 Jul 2019.