Brachial Plexus AnesthesiaNCT02393677
Supraclavicular Brachial Plexus Block Using Ropivacaine Alone and With Dexmedetomidine
A study testing Ropivacaine and Ropivacaine with Dexmedetomidine in people with Brachial Plexus Anesthesia, run by Government Medical College, Haldwani.
Trial summary
80 American Society of Anesthesiologists (ASA) grade I-II patients, 18-60 years old,scheduled for elective upper limb orthopaedic surgery under supraclavicular brachial plexus block, were included in this prospective study. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Anesthesia
- What is being tested?
- Ropivacaine and Ropivacaine with Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Jul 2012
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 80 ASA Grade I and II patients of either sex, aged 18-60 years, undergoing various orthopaedic surgeries on the upper limb under supraclavicular brachial plexus block.
Who cannot join
- Patient refusal
- Patients with chronic pain (pain lasting more than 12 weeks)
- Those using chronic analgesic medications (opioid, non steroidal anti-inflammatory drugs, anticonvulsants, antidepressants)
- Coagulopathy
- History of brachial plexus injury
- Allergy to the study drugs
Show all 9Show fewer
- Patients taking other medications with α-adrenergic blocking effect
- Hepatic or renal insufficiency
- Systemic infection or infection at the site of injection, and shoulder surgery.
About this study
Official title: Supraclavicular Brachial Plexus Block Using Ropivacaine Alone or Combined With Dexmedetomidine for Upper Limb Surgery: A Prospective, Randomized, Double-blinded, Comparative Study
80 American Society of Anesthesiologists (ASA) grade I-II patients, 18-60 years old,scheduled for elective upper limb orthopaedic surgery under supraclavicular brachial plexus block, were included in this prospective study. The patients were randomly assigned to group R (Ropivacaine alone) and group RD (Ropivacaine and dexmedetomidine) (40 patients in each group). Group R received Ropivacaine 0.50% (30 cc) + placebo and group RD received Ropivacaine 0.50% (30 cc) + dexmedetomidine 1 µg/kg.
Read the detailed description
After Institutional Ethical Committee approval and written informed consent, a prospective, randomized, double-blinded study was carried out on 80 ASA Grade I and II patients of either sex, aged 18-60 years, undergoing various orthopaedic surgeries on the upper limb under supraclavicular brachial plexus block. A power analysis was performed to determine the necessary number of patients for each group based on duration of analgesia. With a 2-sided type I error of 5% and study power at 80%, it was estimated that 38 patients would be needed in each group in order to detect a difference of 35 min in the duration of analgesia between the 2 groups. The study was conducted in two groups of 40 patients each. Patients were randomly chosen by computer-generated random selection to one of the following groups:
Group R: Ropivacaine 0.50% (30 cc) + Placebo Group RD: Ropivacaine 0.50% (30 cc) + Dexmedetomidine 1 µg/kg Randomization was performed by an independent statistician and concealed from patients and investigators until completion of statistical analysis. Patients were instructed preoperatively about use of the verbal rating scale (VRS) for pain assessment (VRS: 0 = no pain, 10=worst pain possible). On arrival in the operation room, baseline heart rate, blood pressure and oxygen saturation were recorded. An intravenous line was secured in the unaffected limb and Ringer's lactate was started. Patients were given midazolam intravenous (IV) (0.03 mg/kg) as premedication 10-15 min before beginning each blocks technique. Subcutaneous injection with 2 mL of 2% lidocaine was administered at the needle insertion site. All the patients received brachial plexus block through the supraclavicular approach by an experienced anesthesiologist different from the one assessing the patient intra- and post-operatively. Both were blinded to the treatment groups. Neural localization was achieved by using a nerve locator (Stimuplex® Dig RC, B.Braun, Melsungen AG, Melsungen, Germany) connected to a 22 G, 50-mm-long stimulating needle (Stimuplex, Braun, Germany). The location end point was a distal motor response with an output lower than 0.5 milliampere (mA).
Following negative aspiration, 30 mL of a solution containing local anesthetic combined with placebo or dexmedetomidine as mentioned above was injected and the use of Dexmedetomidine was off-label. A 5-min compression was performed to facilitate an even drug distribution. Sensory blockade was assessed every 3 min and motor block was evaluated every 5 min within the first 30 min following completion of drug administration. Sensory block was confirmed by pinprick sensation using a 23-G needle in all dermatomes of the brachial plexus (C5-T1) i.e. median nerve, radial nerve, ulnar nerve and musculocutaneous nerve. Sensory onset was considered when there was a dull sensation to pin prick along the distribution of any of these nerves (Grade 1). Complete sensory block was considered when there was complete loss of sensation to pin prick.
Sensory block was graded as- Grade 0 Sharp pin felt Grade 1 Analgesia, dull sensation felt Grade 2 Anesthesia, no sensation felt
Motor blockade was evaluated by the ability to flex the elbow and hand against gravity as follows :
Grade 1 Ability to flex and extend the forearm Grade 2 Ability to flex or extend only the wrist and fingers Grade 3 Ability to flex or extend only the fingers Grade 4 Inability to move the forearm, wrist, and fingers Onset of motor block was defined as the time from injection of local anesthetic mixture until achieving a reduction in motor power to grade 3 or less. The block was considered incomplete when any of the segments supplied by median, radial, ulnar and musculocutaneous nerve did not have analgesia even after 30 min of drug injection. These patients were supplemented with intravenous fentanyl (2 μg/ kg) and midazolam (0.03 mg/kg). When more than one nerve remained unaffected, it was considered a failed block. In this case, general anesthesia was given intraoperatively. Patients were monitored for hemodynamic variables such as heart rate, blood pressure and oxygen saturation.
- Conditions
- Brachial Plexus Anesthesia
- Being tested
- Ropivacaine, Ropivacaine with Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Ropin
Ropivacaine 0.5% 30 ml was used to block brachial plexus
Ropivacaine with DexmedetomidineDrug
Also called Ropin with Dextomid
Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Placebo comparator | amide local anesthetic Receives: Drug: Ropivacaine |
| Ropivacaine with Dexmedetomidine | Active comparator | combination of amide local anaesthetic and alpha2 agonist Receives: Drug: Ropivacaine with Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia
Measured: upto 8 hours
Secondary outcomes (3)
Onset of Sensory Block
Measured: 20 minutes
Onset of Motor Block
Measured: 30minutes
Duration of Motor Block
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
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 Brachial Plexus AnesthesiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Haldwani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bikramjit Das, Government Medical College, Haldwani
- Investigators
- Shahin N Jamil, MD, Study director, Professor, Aligarh Muslim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393677
- Sponsor's protocol ID
- DN57/FM
- Status last verified
- Oct 2015
- First submitted
- 15 Mar 2015
- Last updated
- 6 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraclavicular Brachial Plexus Block Using Ropivacaine Alone or Combined With Dexmedetomidine for Upper Limb Surgery: A Prospective, Randomized, Double-blinded, Comparative Study
- ClinicalTrials.gov ID
- NCT02393677
- Acronym / sponsor ID
- DN57/FM
- Conditions
- Brachial Plexus Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Government Medical College, HaldwaniUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 6 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
80 American Society of Anesthesiologists (ASA) grade I-II patients, 18-60 years old,scheduled for elective upper limb orthopaedic surgery under supraclavicular brachial plexus block, were included in this prospective study. The patients were randomly assigned to group R (Ropivacaine alone) and group RD (Ropivacaine and dexmedetomidine) (40 patients in each group). Group R received Ropivacaine 0.50% (30 cc) + placebo and group RD received Ropivacaine 0.50% (30 cc) + dexmedetomidine 1 µg/kg.
Detailed description
After Institutional Ethical Committee approval and written informed consent, a prospective, randomized, double-blinded study was carried out on 80 ASA Grade I and II patients of either sex, aged 18-60 years, undergoing various orthopaedic surgeries on the upper limb under supraclavicular brachial plexus block. A power analysis was performed to determine the necessary number of patients for each group based on duration of analgesia. With a 2-sided type I error of 5% and study power at 80%, it was estimated that 38 patients would be needed in each group in order to detect a difference of 35 min in the duration of analgesia between the 2 groups. The study was conducted in two groups of 40 patients each. Patients were randomly chosen by computer-generated random selection to one of the following groups:
Group R: Ropivacaine 0.50% (30 cc) + Placebo Group RD: Ropivacaine 0.50% (30 cc) + Dexmedetomidine 1 µg/kg Randomization was performed by an independent statistician and concealed from patients and investigators until completion of statistical analysis. Patients were instructed preoperatively about use of the verbal rating scale (VRS) for pain assessment (VRS: 0 = no pain, 10=worst pain possible). On arrival in the operation room, baseline heart rate, blood pressure and oxygen saturation were recorded. An intravenous line was secured in the unaffected limb and Ringer's lactate was started. Patients were given midazolam intravenous (IV) (0.03 mg/kg) as premedication 10-15 min before beginning each blocks technique. Subcutaneous injection with 2 mL of 2% lidocaine was administered at the needle insertion site. All the patients received brachial plexus block through the supraclavicular approach by an experienced anesthesiologist different from the one assessing the patient intra- and post-operatively. Both were blinded to the treatment groups. Neural localization was achieved by using a nerve locator (Stimuplex® Dig RC, B.Braun, Melsungen AG, Melsungen, Germany) connected to a 22 G, 50-mm-long stimulating needle (Stimuplex, Braun, Germany). The location end point was a distal motor response with an output lower than 0.5 milliampere (mA).
Following negative aspiration, 30 mL of a solution containing local anesthetic combined with placebo or dexmedetomidine as mentioned above was injected and the use of Dexmedetomidine was off-label. A 5-min compression was performed to facilitate an even drug distribution. Sensory blockade was assessed every 3 min and motor block was evaluated every 5 min within the first 30 min following completion of drug administration. Sensory block was confirmed by pinprick sensation using a 23-G needle in all dermatomes of the brachial plexus (C5-T1) i.e. median nerve, radial nerve, ulnar nerve and musculocutaneous nerve. Sensory onset was considered when there was a dull sensation to pin prick along the distribution of any of these nerves (Grade 1). Complete sensory block was considered when there was complete loss of sensation to pin prick.
Sensory block was graded as- Grade 0 Sharp pin felt Grade 1 Analgesia, dull sensation felt Grade 2 Anesthesia, no sensation felt
Motor blockade was evaluated by the ability to flex the elbow and hand against gravity as follows :
Grade 1 Ability to flex and extend the forearm Grade 2 Ability to flex or extend only the wrist and fingers Grade 3 Ability to flex or extend only the fingers Grade 4 Inability to move the forearm, wrist, and fingers Onset of motor block was defined as the time from injection of local anesthetic mixture until achieving a reduction in motor power to grade 3 or less. The block was considered incomplete when any of the segments supplied by median, radial, ulnar and musculocutaneous nerve did not have analgesia even after 30 min of drug injection. These patients were supplemented with intravenous fentanyl (2 μg/ kg) and midazolam (0.03 mg/kg). When more than one nerve remained unaffected, it was considered a failed block. In this case, general anesthesia was given intraoperatively. Patients were monitored for hemodynamic variables such as heart rate, blood pressure and oxygen saturation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Placebo comparator | Drug: Ropivacaineamide local anesthetic |
| Ropivacaine with Dexmedetomidine | Active comparator | Drug: Ropivacaine with Dexmedetomidinecombination of amide local anaesthetic and alpha2 agonist |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 80 ASA Grade I and II patients of either sex, aged 18-60 years, undergoing various orthopaedic surgeries on the upper limb under supraclavicular brachial plexus block.
Key exclusion criteria (9 listed)
- Patient refusal
- Patients with chronic pain (pain lasting more than 12 weeks)
- Those using chronic analgesic medications (opioid, non steroidal anti-inflammatory drugs, anticonvulsants, antidepressants)
- Coagulopathy
- History of brachial plexus injury
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: RopinRopivacaine 0.5% 30 ml was used to block brachial plexus | Drug | Ropivacaine |
| Ropivacaine with DexmedetomidineAlso: Ropin with DextomidDexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus | Drug | Ropivacaine with Dexmedetomidine |
Primary outcome
Duration of Analgesia
Time frame: upto 8 hours
3 secondary outcomes
Onset of Sensory Block
Time frame: 20 minutes
Onset of Motor Block
Time frame: 30minutes
Duration of Motor Block
Time frame: 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shahin N Jamil, MD study director
Professor, Aligarh Muslim University
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and Ropivacaine with Dexmedetomidine in people with Brachial Plexus Anesthesia, run by Government Medical College, Haldwani.
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 1 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 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 6 Nov 2015). 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: upto 8 hours). 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 6 Nov 2015.