Clinical trial NCT02482831: The Difference in Duration of Sciatic Nerve Block Between Diabetic and Non-diabetic Patients
Official title: The Difference in Duration of Sciatic Nerve Block Between Diabetic and Non-diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sciatic Nerve Block
Keywords: Sciatic nerve block
block duration
Semmes Weinstein monofilaments
fasting blood glucose
nerve block
sensory block duration
motor block duration
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo unilateral lower limb surgery in Peking Union Medical College Hospital.

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.

Detailed description: This is an observational study. All 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. They were further assigned to either diabetic group or non-diabetic group according to their medical history (primary exposure). The primary end point was the sensory and motor block duration. These durations in terms of sensory and motor blocks of sciatic nerve(dorsal side, plantar side) were assessed at baseline, every 2 hours in 48 hours after the block (except for the second night). In addition, the associations between fasting blood glucose, glycosylated hemoglobin (hemoglobin A1c, HbA1c) and the degree of diabetic retinopathy and the durations of sensory and motor block were also examined. This is not a intervention study, because we will examine the outcomes between diabetic or non-diabetic patients.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists :I-III;
* Age\>=18 years;
* Undergo unilateral lower limb surgery;
* Sign consent form.

Exclusion Criteria:

* Refuse regional Anesthesia;
* Thresh of sensory \>10g;
* Dyskinesia;
* Bleeding disorder;
* Regional skin infection;
* Regional drug allergy;
* Renal disfunction;
* Incompliant to study;
* Drug abuse.

Primary outcomes:
measure: Duration of sensory block
timeFrame: 48 hours
measure: Duration of motor block
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College University
name: Yuguang Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kalichman 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.
citation: Kroin 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.
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.
citation: Sertoz 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.
citation: Kroin 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.
citation: Tang 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.