The Difference in Duration of Sciatic Nerve Block Between Diabetic and Non-diabetic Patients

Sciatic Nerve Block Clinical Trial

— DSNBD  

Official title:

The Difference in Duration of Sciatic Nerve Block Between Diabetic and Non-diabetic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02482831
• Other study ID #: anesthesiologyPUMCH002
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2015
• Last updated: June 23, 2015
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: June 2015
• Source: Peking Union Medical College Hospital
• Contact: Shuai Tang, MD
• Phone: 13718754540
• Email: tangshuai[@]pumch.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sciatic Nerve Block

Intervention

Procedure:
• Subgluteal sciatic nerve block
All patients (either diabetic or non-diabetic patients) received an ultrasound-guided (nerve stimulator assisted) subgluteal sciatic nerve block with 0.75% ropivacaine 20ml.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No