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

June 23, 2015 updated by: Huang YuGuang, Peking Union Medical College Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Yuguang Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who undergo unilateral lower limb surgery in Peking Union Medical College Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours
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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • anesthesiologyPUMCH002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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