Infraclavicular Block Properties in Diabetic Patients

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486535
• Other study ID #: 2018/203
• Status: Completed
• Start date: February 20, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Nerve Block Duration
• Pain, Postoperative

Intervention

Drug:
• Infraclavicular Brachial Plexus Blocks
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.
• Infraclavicular Brachial Plexus Blocks
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.

Locations

Country	Name	City	State
Turkey	Istanbul University, Medical Faculty of Istanbul	Istanbul
Turkey	Metin Sabanci Baltalimani Kemik Hastaliklari Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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/ae — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Time-to-first pain	Postoperative first pain (Numeric rating scale (NRS) =4) (0: no pain, 10: worst pain imaginable)	0-48 hours
Secondary	Pain (NRS) scores	Numeric rating scale (Numeric rating scale (NRS) =4) pain scores (0: no pain, 10: worst pain imaginable)	0-48 hours
Secondary	Rescue analgesic consumption	Used postoperatively if (Numeric rating scale (NRS) =4) (0: no pain, 10: worst pain imaginable)	0-48 hours