NCT02482831

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

June 15, 2015

Last Update Submit

June 23, 2015

Conditions

Keywords

Sciatic nerve blockblock durationSemmes Weinstein monofilamentsfasting blood glucosenerve blocksensory block durationmotor block duration

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

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

Diabetesnon-Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Refuse regional Anesthesia;
  • Thresh of sensory \>10g;
  • Dyskinesia;
  • Bleeding disorder;
  • Regional skin infection;
  • Regional drug allergy;
  • Renal disfunction;
  • Incompliant to study;
  • Drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (7)

  • 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.

    PMID: 19920415BACKGROUND
  • 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.

    PMID: 1443749BACKGROUND
  • 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.

    PMID: 20607875BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Yuguang Huang, MD

    Peking Union Medical College University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuai Tang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 26, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations