The Difference in Duration of Sciatic Nerve Block Between Diabetic and Non-diabetic Patients
DSNBD
1 other identifier
observational
53
1 country
1
Brief Summary
This study aims to compare the sensory and motor block duration and the incidence of nerve injury after sciatic nerve block between diabetic and non-diabetic patients, and screen for the factors that may affect the block recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 15, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJune 26, 2015
June 1, 2015
9 months
June 15, 2015
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Duration of sensory block
Sensory block is measured by Semmes Weinstein monofilaments. The block is measured at baseline, and every 2hours in 48 hours after the block.
48 hours
Duration of motor block
Motor blocks is visualized. The block is measured at baseline, and every 2hours in 48 hours after the block
48 hours
Study Arms (2)
Diabetes
Diabatic participants who experienced unilateral lower limb surgery and received an ultrasound-guided (nerve stimulator assisted) subgluteal sciatic nerve block with 0.75% ropivacaine 20ml in Peking Union Medical College Hospital were selected.
non-Diabetes
Non-diabatic participants who experienced unilateral lower limb surgery and received an ultrasound-guided (nerve stimulator assisted) subgluteal sciatic nerve block with 0.75% ropivacaine 20ml in Peking Union Medical College Hospital were selected.
Interventions
All patients (either diabetic or non-diabetic patients) received an ultrasound-guided (nerve stimulator assisted) subgluteal sciatic nerve block with 0.75% ropivacaine 20ml.
Eligibility Criteria
Patients who undergo unilateral lower limb surgery in Peking Union Medical College Hospital.
You may qualify if:
- American Society of Anesthesiologists :I-III;
- Age\>=18 years;
- Undergo unilateral lower limb surgery;
- Sign consent form.
You may not qualify if:
- Refuse regional Anesthesia;
- Thresh of sensory \>10g;
- Dyskinesia;
- Bleeding disorder;
- Regional skin infection;
- Regional drug allergy;
- Renal disfunction;
- Incompliant to study;
- Drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Related Publications (7)
Gebhard RE, Nielsen KC, Pietrobon R, Missair A, Williams BA. Diabetes mellitus, independent of body mass index, is associated with a "higher success" rate for supraclavicular brachial plexus blocks. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):404-7. doi: 10.1097/AAP.0b013e3181ada58d.
PMID: 19920415BACKGROUNDKalichman MW, Calcutt NA. Local anesthetic-induced conduction block and nerve fiber injury in streptozotocin-diabetic rats. Anesthesiology. 1992 Nov;77(5):941-7. doi: 10.1097/00000542-199211000-00017.
PMID: 1443749BACKGROUNDKroin JS, Buvanendran A, Williams DK, Wagenaar B, Moric M, Tuman KJ, Kerns JM. Local anesthetic sciatic nerve block and nerve fiber damage in diabetic rats. Reg Anesth Pain Med. 2010 Jul-Aug;35(4):343-50. doi: 10.1097/aap.0b013e3181e82df0.
PMID: 20607875BACKGROUNDCuvillon 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: 23348203RESULTSertoz N, Deniz MN, Ayanoglu HO. Relationship between glycosylated hemoglobin level and sciatic nerve block performance in diabetic patients. Foot Ankle Int. 2013 Jan;34(1):85-90. doi: 10.1177/1071100712460366.
PMID: 23386766RESULTKroin JS, Buvanendran A, Tuman KJ, Kerns JM. Effect of acute versus continuous glycemic control on duration of local anesthetic sciatic nerve block in diabetic rats. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):595-600. doi: 10.1097/AAP.0b013e31826742fd.
PMID: 22996200RESULTTang S, Wang J, Tian Y, Li X, Cui Q, Xu M, Song X, Zheng Y, Yang H, Ma C, Zhan L, Zhu C, Zhang Y, Yao M, Huang Y. Sex-dependent prolongation of sciatic nerve blockade in diabetes patients: a prospective cohort study. Reg Anesth Pain Med. 2019 Jul 12:rapm-2019-100609. doi: 10.1136/rapm-2019-100609. Online ahead of print.
PMID: 31302640DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Yuguang Huang, MD
Peking Union Medical College University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 15, 2015
First Posted
June 26, 2015
Study Start
September 1, 2014
Primary Completion
June 1, 2015
Study Completion
August 1, 2015
Last Updated
June 26, 2015
Record last verified: 2015-06