Skip to main content
OpenTrials
Completed

NCT Number: NCT03486535

Infraclavicular Block Properties in Diabetic Patients

Background and objectives: The investigators are performing this study to explore whether the presence of diabetes mellitus (DM) will affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing elbow, forearm and hand surgery.

The primary hypothesis is that the sensory block duration will be delaying in diabetic patients.

Methods: Ethics committee approval has been obtained and after written informed consents, 60 patients are planning to be enrolled to the study. Diabetic patients will be included in Group DM and non-diabetics are included in Group NODM. All patients will receive ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Our primary outcome is sensory block duration, and secondary outcomes are 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 will be assessed by blind investigators.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nerve Block Duration Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University, Medical Faculty of Istanbul, Istanbul, Turkey (Türkiye)

Loading trial locations.

About this study

Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral nerve blocks need to be investigated on human models, besides animal researches. The investigators have been performing this study to explore whether the presence of DM will affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing elbow, forearm, and hand surgery. The primary hypothesis is that the sensory block duration will be delaying in diabetic patients.

Methods: After obtaining ethics committee approval and written informed consent, 60 patients with American Society of Anesthesiologists (ASA) physical status I-IV and aged between 40 and 80 years are enrolled to the study. Diabetic patients will be included in Group DM and non-diabetics will be included in Group NODM. All patients will receive ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Postoperatively, patients will be administered diclomec SR 75 mg IM first and if still needed tramadol 100 mg IV as rescue analgesics (numeric rating scale (NRS) is ≥4). Our primary outcome is sensory block duration, and secondary outcomes are 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 through the postoperative first 2 days. All outcomes will be assessed by blind investigators.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients scheduled for arm, elbow, forearm, and hand surgery American Society of Anesthesiologists (ASA) physical status I-IV 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

Treatment and study plan

Infraclavicular Brachial Plexus Blocks

Drug

All patients will receive Infraclavicular Brachial Plexus Blocks with the mixture of lidocaine and bupivacaine. This is an observational study, because all patients will receive the same blocks with the same doses of the local anesthetics. The only difference between groups is including patients with or without Diabetes Mellitus diagnosis. The intervention is the same and these patients cannot be randomized. The aim is investigating the effect of this local anesthetic mixture in Diabetic patients.

Other names: Same interventions, drugs and concentrations

Primary outcomes

  1. Sensory block duration

    Time frame: 0-24 hours

    Time interval between a successful block (0: full sensation, 1: less sensation, and 2: no sensation) (≥7/8) and the complete restoration of all the senses controlled by the radial, ulnar, median and musculocutaneous nerves (0/8)

Secondary outcomes

  1. Sensory block onset time

    Time frame: 0-30 minutes

    Physical examination with pin-prick test until the block onset (0: full sensation, 1: less sensation, and 2: no sensation) (≥7/8)

  2. Motor block onset time

    Time frame: 0-30 minutes

    Physical examination with modified Bromage scale until the block onset (0: normal motor function; 1: partial motor block, able to flex the elbow and move the fingers but unable to raise the extended arm; 2: almost complete motor block, unable to flex the elbow but able to move the fingers; and 3: complete motor block, unable to move the arm, elbow, or fingers) (≥9/12)

  3. Motor block duration

    Time frame: 0-24 hours

    Time interval between a successful block (0: normal motor function; 1: partial motor block, able to flex the elbow and move the fingers but unable to raise the extended arm; 2: almost complete motor block, unable to flex the elbow but able to move the fingers; and 3: complete motor block, unable to move the arm, elbow, or fingers) (≥9/12) and the complete restoration of all motor responses controlled by the radial, ulnar, median and musculocutaneous nerves (0/12).

  4. Time-to-first pain

    Time frame: 0-48 hours

    Postoperative first pain (Numeric rating scale (NRS) ≥4) (0: no pain, 10: worst pain imaginable)

  5. Pain (NRS) scores

    Time frame: 0-48 hours

    Numeric rating scale (Numeric rating scale (NRS) ≥4) pain scores (0: no pain, 10: worst pain imaginable)

  6. Rescue analgesic consumption

    Time frame: 0-48 hours

    Used postoperatively if (Numeric rating scale (NRS) ≥4) (0: no pain, 10: worst pain imaginable)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2018
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.