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

NCT ID: NCT03346993

Last Updated: 2017-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2017-01-01

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.

Conditions

Effect Increased

Keywords

Bupivacaine; Brachial Plexus Block; Ultrasound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

24C° 0,5% bupivacaine group

24C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 24C° 20 ml 0,5% bupivacaine

Group Type: EXPERIMENTAL

Bupivacaine Hydrochloride 5 MG/ML

Intervention Type: DRUG

Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine

37C° 0,5% bupivacaine group

37C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 37C° 20 ml 0,5% bupivacaine

Group Type: EXPERIMENTAL

Bupivacaine Hydrochloride 5 MG/ML

Intervention Type: DRUG

Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine

Interventions

Bupivacaine Hydrochloride 5 MG/ML

Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erzurum Palandöken State Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Erkan Cem ÇELİK

Consult of Anesthesiologhy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Palandöken State Hospital

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Palandöken State Hospital

Identifier Type: -

Identifier Source: org_study_id