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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02482831
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sciatic Nerve Block	Procedure: Subgluteal sciatic nerve block

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 53 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Difference in Duration of Sciatic Nerve Block Between Diabetic and Non-diabetic Patients
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Anticipated Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures

1. Duration of sensory block [48 hours]

   Sensory block is measured by Semmes Weinstein monofilaments. The block is measured at baseline, and every 2hours in 48 hours after the block.

2. Duration of motor block [48 hours]

   Motor blocks is visualized. The block is measured at baseline, and every 2hours in 48 hours after the block

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

• Principal Investigator: Yuguang Huang, MD, Peking Union Medical College University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Kalichman MW, Calcutt NA. Local anesthetic-induced conduction block and nerve fiber injury in streptozotocin-diabetic rats. Anesthesiology. 1992 Nov;77(5):941-7.
• 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.

• Responsible Party: Huang YuGuang, Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT02482831
• Other Study ID Numbers: anesthesiologyPUMCH002
• First Posted: Jun 26, 2015
• Last Update Posted: Jun 26, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Huang YuGuang, Professor, Peking Union Medical College Hospital: Sciatic nerve block; block duration; Semmes Weinstein monofilaments; fasting blood glucose; nerve block; sensory block duration; motor block duration

Study Results

No Results Posted as of Jun 26, 2015