Infraclavicular Block Properties in Diabetic Patients

NCT03486535 | Completed FDA Drug

• 1 other identifier: 2018/203
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetes Mellitus; Nerve Block Duration; Pain, Postoperative

Keywords

Diabetes mellitus; Infraclavicular 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 (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 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

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

Non-diabetic patients

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

Interventions

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.

Also known as: Same interventions, drugs and concentrations

Diabetic patients

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for arm, elbow, forearm, and hand surgery.

You may qualify if:

• Patients scheduled for arm, elbow, forearm, and hand surgery American Society of Anesthesiologists (ASA) physical status I-IV 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 (2)

Istanbul University, Medical Faculty of Istanbul

Istanbul, 34093, Turkey (Türkiye)

Location

Metin Sabancı Baltalimanı Kemik Hastalıkları Training and Research Hospital

Istanbul, 34470, Turkey (Türkiye)

Location

Related Publications (2)

• Salviz EA, Onbasi S, Ozonur A, Orhan-Sungur M, Berkoz O, Tugrul KM. Comparison of Ultrasound-Guided Axillary Brachial Plexus Block Properties in Diabetic and Nondiabetic Patients: A Prospective Observational Study. J Hand Surg Am. 2017 Mar;42(3):190-197. doi: 10.1016/j.jhsa.2017.01.009.

  PMID: 28259276 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

Interventions

Pharmaceutical Preparations

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

  Istanbul University, Medical Faculty of Istanbul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assoc Prof, EDRA

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 3, 2018
• Study Start: February 20, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: July 30, 2019

Record last verified: 2018-03

Locations

TU (2)