Skip to main content
OpenTrials
Completed

NCT Number: NCT03346993

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Palandöken State Hospital

Erzurum, 25080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Neurological and neuromuscular disorders,
  • Psychiatric problems
  • Cardiopulmonary diseases
  • Coagulopathy
  • Infections
  • Sllergy to local anesthetic agents.

Treatment and study plan

Bupivacaine Hydrochloride 5 MG/ML

Drug

Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine

Primary outcomes

  1. Evaluate sensory block's onset time

    Time frame: 30 minutes after Brachial Plexus Block

    Pain was evaluated by pinprick test (yes-there is a pain/ no-there is no pain)

Secondary outcomes

  1. Evaluate motor block's onset times

    Time frame: 30 minutes after Brachial Plexus Block

    Motion on distal arm was evaluated by bromage scale (0- full flexion of distal arm, 3-unable to move distal arm)

Sponsors and collaborators

Lead sponsor

Erzurum Palandöken State Hospital

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Nov 20, 2017
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.