Axillary Block Properties in Diabetic Patients

March 14, 2016 updated by: Emine Aysu Salviz, MD, Istanbul University

Comparison of Ultrasound-Guided Axillary Brachial Plexus Block Properties in Diabetic and Non-diabetic Patients: A Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral nerve block anesthesia was mostly investigated in animal researches, and effects on human models are required to be clarified. The investigators performed this study to explore whether the presence of 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 with American Society of Anesthesiologists (ASA) physical status I-III and aged between 40 and 75 years 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%. Postoperatively, patients were administered paracetamol as rescue analgesics, if numeric rating scale (NRS) was ≥4. 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.

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Istanbul University, Department of anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective forearm and/or hand surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
All patients received ultrasound-guided axillary brachial plexus block (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.
Other Names:
  • ABPBs
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
All patients received ultrasound-guided axillary brachial plexus block (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.
Other Names:
  • ABPBs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory block duration
Time Frame: 0-24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (NRS) scores
Time Frame: 0-48 hours
Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)
0-48 hours
Sensory block onset time
Time Frame: 0-30 minutes
Physical examination with pin-prick test (≥7/8)
0-30 minutes
Motor block onset time
Time Frame: 0-30 minutes
Physical examination with modified Bromage scale (≥9/12)
0-30 minutes
Motor block duration
Time Frame: 0-24 hours
Time interval between a successful block and the complete restoration of all motor responses controlled by the radial, ulnar, median and musculocutaneous nerves.
0-24 hours
Time-to-first pain
Time Frame: 0-48 hours
Postoperative first pain (NRS ≥4)
0-48 hours
Rescue analgesic consumption
Time Frame: 0-48 hours
Used postoperatively if NRS ≥4
0-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Emine A Salviz, MD, Design and conduct the study, review and analyze the data, and write the manuscript

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 13, 2016

First Submitted That Met QC Criteria

February 13, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/1869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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