Clinical trial NCT03486535: Infraclavicular Block Properties in Diabetic Patients
Official title: Ultrasound-Guided Infraclavicular Brachial Plexus Block Properties in Diabetic and Non-diabetic Patients: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Nerve Block Duration
Pain, Postoperative
Keywords: Diabetes mellitus
Infraclavicular brachial plexus block
Block duration
Time-to-first pain
Postoperative analgesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for arm, elbow, forearm, and hand surgery.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensory block duration
timeFrame: 0-24 hours
Secondary outcomes:
measure: Sensory block onset time
timeFrame: 0-30 minutes
measure: Motor block onset time
timeFrame: 0-30 minutes
measure: Motor block duration
timeFrame: 0-24 hours
measure: Time-to-first pain
timeFrame: 0-48 hours
measure: Pain (NRS) scores
timeFrame: 0-48 hours
measure: Rescue analgesic consumption
timeFrame: 0-48 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Medical Faculty of Istanbul
city: Istanbul
country: Turkey
facility: Metin Sabancı Baltalimanı Kemik Hastalıkları Training and Research Hospital
Study officials:
affiliation: Istanbul University, Medical Faculty of Istanbul
name: Emine A Salviz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.