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

• ClinicalTrials.gov Identifier: NCT03346993
• Recruitment Status: Completed
• First Posted: November 20, 2017
• Last Update Posted: November 20, 2017
• Sponsor: Erzurum Palandöken State Hospital
• Information provided by (Responsible Party): Erkan Cem ÇELİK, Erzurum Palandöken State Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Effect Increased	Drug: Bupivacaine Hydrochloride 5 MG/ML	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?
• Actual Study Start Date: July 1, 2016
• Actual Primary Completion Date: July 1, 2016
• Actual Study Completion Date: January 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Turkey

Palandöken State Hospital

Erzurum, Turkey, 25080

Sponsors and Collaborators

Erzurum Palandöken State Hospital

More Information

• Responsible Party: Erkan Cem ÇELİK, Consult of Anesthesiologhy, Erzurum Palandöken State Hospital
• ClinicalTrials.gov Identifier: NCT03346993
• Other Study ID Numbers: Palandöken State Hospital
• First Posted: November 20, 2017
• Last Update Posted: November 20, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by Erkan Cem ÇELİK, Erzurum Palandöken State Hospital:

Bupivacaine; Brachial Plexus Block; Ultrasound

Additional relevant MeSH terms:

Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents