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

NCT03346993 | Completed Phase 1 DMC

• 1 other identifier: Palandöken State Hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect Increased

Keywords

Bupivacaine; Brachial Plexus Block; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate motor block's onset times

  30 minutes after Brachial Plexus Block

Study Arms (2)

24C° 0,5% bupivacaine group

EXPERIMENTAL

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

37C° 0,5% bupivacaine group

EXPERIMENTAL

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

Interventions

Bupivacaine Hydrochloride 5 MG/ML DRUG

Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine

24C° 0,5% bupivacaine group; 37C° 0,5% bupivacaine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Erzurum Palandöken State Hospital: lead

Study Sites (1)

Palandöken State Hospital

Erzurum, 25080, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consult of Anesthesiologhy

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 20, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: January 1, 2017
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

TU (1)