- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02393677
Supraclavicular Brachial Plexus Block Using Ropivacaine Alone and With Dexmedetomidine
Supraclavicular Brachial Plexus Block Using Ropivacaine Alone or Combined With Dexmedetomidine for Upper Limb Surgery: A Prospective, Randomized, Double-blinded, Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Ropivacaine
amide local anesthetic
|
Ropivacaine 0.5% 30 ml was used to block brachial plexus
Other Names:
|
Active Comparator: Ropivacaine with Dexmedetomidine
combination of amide local anaesthetic and alpha2 agonist
|
Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of Analgesia
Time Frame: upto 8 hours
|
upto 8 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Onset of Sensory Block
Time Frame: 20 minutes
|
20 minutes
|
Onset of Motor Block
Time Frame: 30minutes
|
30minutes
|
Duration of Motor Block
Time Frame: 6 hours
|
6 hours
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Haemodynamic Changes
Time Frame: 8 hours
|
8 hours
|
Complications
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
Investigators
- Study Director: Shahin N Jamil, MD, Professor, Aligarh Muslim University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Dexmedetomidine
- Ropivacaine
Other Study ID Numbers
- DN57/FM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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