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Status unknownNCT02482831DSNBDUpdated Jun 26, 2015

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

An observational study in Sciatic Nerve Block, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-26.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
53
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sciatic Nerve Block

Keywords

  • Sciatic nerve block
  • block duration
  • Semmes Weinstein monofilaments
  • fasting blood glucose
  • nerve block
  • sensory block duration
  • motor block duration
03

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
53 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • ProcedureSubgluteal 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 48 hours

  2. Duration of motor block

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

    Time frame: 48 hours

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing, China
    • Shuai Tang, MD · Contact · tangshuai@pumch.cn · 13718754540
    • Yuguang Huang, MD · Principal investigator
    Recruiting
08

References and documents

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. PubMed 19920415 ↗
  • 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. PubMed 1443749 ↗
  • 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. PubMed 20607875 ↗
  • 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. PubMed 23348203 ↗
  • 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. PubMed 23386766 ↗
  • 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. PubMed 22996200 ↗
  • 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. PubMed 31302640 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02482831
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Huang YuGuang (Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Jun 26, 2015
Start date
Sep 2014
Primary completion
Jun 2015
Completion
Aug 2015 (estimated)
Last update
Jun 26, 2015

Study contacts

Shuai Tang, MD
Contact
tangshuai@pumch.cn
13718754540
Yuguang Huang, MD
principal investigator · Peking Union Medical College University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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