An observational study in Diabetes Mellitus, Nerve Block Duration and Pain, Postoperative, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-16.
Sponsored by Istanbul University · Observational
Background and objectives: The investigators performed this study to explore whether the presence of diabetes mellitus (DM) would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary hypothesis was that the sensory block duration would be delayed in diabetic patients.
Methods: After obtaining ethics committee approval and written informed consent, 71 patients were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Our primary outcome was sensory block duration, and secondary outcomes were 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 were assessed by a blinded investigators.
Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral nerve block anesthesia was mostly investigated in animal researches, and effects on human models are required to be clarified. The investigators performed this study to explore whether the presence of DM would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary hypothesis was that the sensory block duration would be delayed in diabetic patients.
Methods: After obtaining ethics committee approval and written informed consent, 71 patients with American Society of Anesthesiologists (ASA) physical status I-III and aged between 40 and 75 years were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Postoperatively, patients were administered paracetamol as rescue analgesics, if numeric rating scale (NRS) was ≥4. Our primary outcome was sensory block duration, and secondary outcomes were 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 were assessed by a blinded investigators.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 71 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients scheduled for elective forearm and/or hand surgery
Patients scheduled for elective forearm and/or hand surgery American Society of Anesthesiologists (ASA) physical status I-III 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
Patients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.
Drug: Axillary Brachial Plexus Blocks
Patients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.
Drug: Axillary Brachial Plexus Blocks
All patients received ultrasound-guided axillary brachial plexus block (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.
Also known as: ABPBs
Sensory block duration
Time interval between a successful block and the complete restoration of all the senses controlled by the radial, ulnar, median and musculocutaneous nerves.
Time frame: 0-24 hours
Sensory block onset time
Physical examination with pin-prick test (≥7/8)
Time frame: 0-30 minutes
Motor block onset time
Physical examination with modified Bromage scale (≥9/12)
Time frame: 0-30 minutes
Motor block duration
Time interval between a successful block and the complete restoration of all motor responses controlled by the radial, ulnar, median and musculocutaneous nerves.
Time frame: 0-24 hours
Time-to-first pain
Postoperative first pain (NRS ≥4)
Time frame: 0-48 hours
Pain (NRS) scores
Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)
Time frame: 0-48 hours
Rescue analgesic consumption
Used postoperatively if NRS ≥4
Time frame: 0-48 hours
Plan to share: No
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Istanbul University