Infraclavicular Block Properties in Diabetic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Nerve Block Duration, Pain, Postoperative

Intervention / Treatment
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* Drug: Infraclavicular Brachial Plexus Blocks
* Drug: Infraclavicular Brachial Plexus Blocks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic patients<br>Diabetic patients will receive ultrasound-guided infraclavicular brachial plexus blocks (ICBs) with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. | Drug: Infraclavicular Brachial Plexus Blocks<br>* 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.<br>* Other names: Same interventions, drugs and concentrations;|
| Non-diabetic patients<br>Nondiabetic patients will receive ultrasound-guided infraclavicular brachial plexus blocks (ICBs) with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. | Drug: Infraclavicular Brachial Plexus Blocks<br>* 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 Nondiabetic patients.<br>* Other names: Same interventions, drugs and concentrations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block duration | 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) | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block onset time | Physical examination with pin-prick test until the block onset (0: full sensation, 1: less sensation, and 2: no sensation) (≥7/8) | 0-30 minutes | 
| Motor block onset time | 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) | 0-30 minutes | 
| Motor block duration | 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). | 0-24 hours | 
| Time-to-first pain | Postoperative first pain (Numeric rating scale (NRS) ≥4) (0: no pain, 10: worst pain imaginable) | 0-48 hours | 
| Pain (NRS) scores | Numeric rating scale (Numeric rating scale (NRS) ≥4) pain scores (0: no pain, 10: worst pain imaginable) | 0-48 hours | 
| Rescue analgesic consumption | Used postoperatively if (Numeric rating scale (NRS) ≥4) (0: no pain, 10: worst pain imaginable) | 0-48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Infraclavicular brachial plexus block, Block duration, Time-to-first pain, Postoperative analgesia