Axillary Block Properties in Diabetic Patients

NCT02685475 | Completed

• 1 other identifier: 2014/1869
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Background and objectives: The investigators performed this study to explore whether the presence of diabetes mellitus (DM) would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary hypothesis was that the sensory block duration would be delayed in diabetic patients. Methods: After obtaining ethics committee approval and written informed consent, 71 patients were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Our primary outcome was sensory block duration, and secondary outcomes were sensory and motor block onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores and rescue analgesic consumption (NRS) ≥4) through the postoperative first 2 days. All outcomes were assessed by a blinded investigators.

Conditions

Diabetes Mellitus; Nerve Block Duration; Pain, Postoperative

Keywords

Diabetes mellitus; Axillary brachial plexus block; Block duration; Time-to-first pain; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Sensory block duration

  Time interval between a successful block and the complete restoration of all the senses controlled by the radial, ulnar, median and musculocutaneous nerves.

  0-24 hours

Secondary Outcomes (6)

• Sensory block onset time

  0-30 minutes

• Motor block onset time

  0-30 minutes

• Motor block duration

  0-24 hours

• Time-to-first pain

  0-48 hours

• Pain (NRS) scores

  0-48 hours

Study Arms (2)

Diabetic patients

Patients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.

Drug: Axillary Brachial Plexus Blocks

Non-diabetic patients

Patients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.

Drug: Axillary Brachial Plexus Blocks

Interventions

Axillary Brachial Plexus Blocks DRUG

All patients received ultrasound-guided axillary brachial plexus block (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.

Also known as: ABPBs

Diabetic patients; Non-diabetic patients

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective forearm and/or hand surgery

You may qualify if:

• Patients scheduled for elective forearm and/or hand surgery American Society of Anesthesiologists (ASA) physical status I-III No regional anesthesia contraindication

You may not qualify if:

• Type 1 DM Type 2 DM patients with only 'diet-controlled' therapy Difficulty with understanding the block and follow-up instructions Significant neurologic disorders Psychiatric or cognitive disorders History of substance abuse Acute and/or chronic opioid use Local anaesthetic hypersensitivity or allergy

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (3)

• Gebhard RE, Nielsen KC, Pietrobon R, Missair A, Williams BA. Diabetes mellitus, independent of body mass index, is associated with a "higher success" rate for supraclavicular brachial plexus blocks. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):404-7. doi: 10.1097/AAP.0b013e3181ada58d.

  PMID: 19920415 RESULT

• Sertoz N, Deniz MN, Ayanoglu HO. Relationship between glycosylated hemoglobin level and sciatic nerve block performance in diabetic patients. Foot Ankle Int. 2013 Jan;34(1):85-90. doi: 10.1177/1071100712460366.

  PMID: 23386766 RESULT

• Cuvillon P, Reubrecht V, Zoric L, Lemoine L, Belin M, Ducombs O, Birenbaum A, Riou B, Langeron O. Comparison of subgluteal sciatic nerve block duration in type 2 diabetic and non-diabetic patients. Br J Anaesth. 2013 May;110(5):823-30. doi: 10.1093/bja/aes496. Epub 2013 Jan 24.

  PMID: 23348203 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Pain, Postoperative

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Emine A Salviz, MD

  Design and conduct the study, review and analyze the data, and write the manuscript

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Attending Anesthesiologist

Study Record Dates

• First Submitted: February 13, 2016
• First Posted: February 18, 2016
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)