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

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ClinicalTrials.gov Identifier: NCT02482831
Recruitment Status : Unknown
Verified June 2015 by Huang YuGuang, gwcmc.
Recruitment status was:  Recruiting
First Posted : June 26, 2015
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Huang YuGuang, gwcmc

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
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 Type : Observational
Estimated 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 : September 2014
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : August 2015

Group/Cohort 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.




Primary Outcome Measures :
  1. Duration of sensory block [ Time Frame: 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 [ Time Frame: 48 hours ]
    Motor blocks is visualized. The block is measured at baseline, and every 2hours in 48 hours after the block



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergo unilateral lower limb surgery in Peking Union Medical College Hospital.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482831


Contacts
Contact: Shuai Tang, MD 13718754540 tangshuai@pumch.cn

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Shuai Tang, MD    13718754540    tangshuai@pumch.cn   
Principal Investigator: Yuguang Huang, MD         
Sponsors and Collaborators
gwcmc
Investigators
Principal Investigator: Yuguang Huang, MD Peking Union Medical College University

Publications of Results:
Other Publications:
Responsible Party: Huang YuGuang, Professor, gwcmc
ClinicalTrials.gov Identifier: NCT02482831     History of Changes
Other Study ID Numbers: anesthesiologyPUMCH002
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by Huang YuGuang, gwcmc:
Sciatic nerve block
block duration
Semmes Weinstein monofilaments
fasting blood glucose
nerve block
sensory block duration
motor block duration

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents