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Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?

Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03346993
Enrollment
60
Registered
2017-11-20
Start date
2016-07-01
Completion date
2017-01-01
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect Increased

Keywords

Bupivacaine, Brachial Plexus Block, Ultrasound

Brief summary

Brachial plexus blocks have some advantages, but also have some disadvantages as well. As with all nerve blocks, having to wait sometime for an effective block, sometimes failure to achieve an adequate block and possible requirement for isolated nerve block, having to wait a long time for resolution of the block, and immobilization of the extremity for some time can be seen as handicaps for brachial plexus block as well. In the present study, Study was aimed to compare the effects of bupivacaine warmed to body temperature and kept at room temperature on the onset time of ultrasound guided infraclavicular brachial plexus block.

Detailed description

The study design was approved by the locale ethics committee. This double-blinded, randomized, controlled clinical trial recruited 60 patients aged between 18 and 65 years with the American society of anesthesiologists (ASA) physical status classification systems I/II and III who were candidated for surgical operations on any of the forearm, wrist and hand regions. All the participants were asked to sign an informed consent form after having been provided with details of the aim and proceedings of the study. Patients were excluded from the study if they had a neurological and neuromuscular disorders, psychiatric problems, cardiopulmonary diseases, coagulopathy, infections or allergy to local anesthetic agents. The patients were equally and randomly distributed into a 24C° 20 ml 0,5% bupivacaine group (Group 1), and 37C° 20 ml 0,5% bupivacaine group (Group 2) via closed envelope technique. All the participants were premedicated with 0.05 mg/kg of intravenous midazolam and monitored routinely before attempting nerve block. Bupivacaine stored for at least 2 hours in a bain-marie (Memmert Waterbath WNB7, Germany) at 38˚C (regular temperature calibration was made) for Group 2. The block process was accomplished by an anesthesiologist, who was blind to the temperature of bupivacaine and local anesthetic agent was administered by different anesthesiologist. At the end of the ICBP block, an anesthetist blinded to the technique evaluated sensory and motor block in every minutes between 5th and 30th minutes as follows. The innervated areas (each dermatome) was evaluated using a pinprick test. The motor block was evaluated by bromage modified scale in every minutes between 10th and 30th minutes. Anxious patients were administered additional midazolam. Subjects refusing awake surgery were administered a propofol infusion with supplemental oxygen as necessary.

Interventions

Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine

Sponsors

Erzurum Palandöken State Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Patients aged between 18 and 65 years 2. American society of anesthesiologists (ASA) physical status classification systems I/II and III 3. Candidate for surgical operations on any of the forearm, wrist and hand regions.

Exclusion criteria

1. Neurological and neuromuscular disorders, 2. Psychiatric problems 3. Cardiopulmonary diseases 4. Coagulopathy 5. Infections 6. Sllergy to local anesthetic agents.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate sensory block's onset time30 minutes after Brachial Plexus BlockPain was evaluated by pinprick test (yes-there is a pain/ no-there is no pain)

Secondary

MeasureTime frameDescription
Evaluate motor block's onset times30 minutes after Brachial Plexus BlockMotion on distal arm was evaluated by bromage scale (0- full flexion of distal arm, 3-unable to move distal arm)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026