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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT02393677
Study groupRoleWhat they receive
RopivacainePlacebo comparatoramide local anesthetic
Receives: Drug: Ropivacaine
Ropivacaine with DexmedetomidineActive comparatorcombination 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.

  1. Duration of Analgesia

    Measured: upto 8 hours

Secondary outcomes (3)
  1. Onset of Sensory Block

    Measured: 20 minutes

  2. Onset of Motor Block

    Measured: 30minutes

  3. 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.

  1. First posted19 Mar 2015 (estimated)
  2. Study startJul 2011
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

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)
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
Data monitoring committee
No

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.

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