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.

Study Overview

• Status: Completed
• Conditions: Effect Increased
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride 5 MG/ML

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25080
    • Palandöken State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 24C° 0,5% bupivacaine group; 24C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 24C° 20 ml 0,5% bupivacaine	Drug: Bupivacaine Hydrochloride 5 MG/ML; Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine
Experimental: 37C° 0,5% bupivacaine group; 37C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 37C° 20 ml 0,5% bupivacaine	Drug: Bupivacaine Hydrochloride 5 MG/ML; Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate sensory block's onset time	Pain was evaluated by pinprick test (yes-there is a pain/ no-there is no pain)	30 minutes after Brachial Plexus Block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate motor block's onset times	Motion on distal arm was evaluated by bromage scale (0- full flexion of distal arm, 3-unable to move distal arm)	30 minutes after Brachial Plexus Block

Collaborators and Investigators

• Sponsor: Erzurum Palandöken State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; Bupivacaine; Brachial Plexus Block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Palandöken State Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No