Sciatic Nerve Blocks With or Without Femoral Block Versus... | NCT02727348

Studies
Sciatic Nerve Blocks With or Without Femoral Block Versus Spinal Anaesthesia in Patients Undergoing Diabetic Foot Surgery

NCT02727348

Sponsor

University of Malaya

Status

Completed

Last Update Posted

Apr 4, 2016Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Diabetic Foot

Interventions

Sciatic with or without femoral block
Spinal anaesthesia

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Apr 30, 2014

First Submission Date that Met QC Criteria

Mar 29, 2016

First Posted Date

Apr 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2016

Last Update Posted Date

Apr 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background:

Dysautonomia refers to the abnormal function of the autonomic nervous system including sympathetic and parasympathetic nervous system. Diabetes mellitus causes secondary dysautonomias (1). The Survey of Autonomic Symptoms (SAS) is a simple and validated tool to assess the presence and severity of autonomic symptoms (2).

Diabetic patients also suffer from chronic neuropathic pain. After amputation surgeries, up to 78% of these patients may develop post surgical neuropathic pain (3). The self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) is validated as a diagnostic tool to assess patients with neuropathic pain (4). This scale will be used to assess if there is any changes in the pain experienced after diabetic foot surgery.

Currently, both spinal anaesthesia (SAB) and ultrasound guided femoral and sciatic peripheral nerve blocks (FSNB) are acceptable anaesthesia for dysautonomic diabetic patients with diabetic foot ulcer going for wound debridement, Ray's amputation and below knee amputation (5)

Many studies have compared multiple perioperative parameters of patients undergoing lower limb surgery under peripheral nerve blocks versus spinal anaesthesia. These parameters include preparation time, anaesthetic complications (e.g. hypotension, nausea and vomiting, post-dural puncture headache, urinary retention), patient satisfaction and postoperative pain control (6,7,8).

The investigators want to study if patients with dysautonomia have a different haemodynamic response to spinal anaesthesia or peripheral nerve blockade changes compared to patients with normal autonomic function.

Secondarily, the investigators would also study if there is a difference in post operative pain control as well as incidence in chronic pain in patients who receive spinal anaesthesia versus peripheral nerve blockade.

Detailed Description

Currently, both spinal anaesthesia (SAB) and ultrasound guided femoral and/or sciatic peripheral nerve blocks (FSNB) are acceptable anaesthesia for dysautonomic diabetic patients with diabetic foot ulcer going for wound debridement, Ray's amputation and below knee amputation (5)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sciatic block with or without femoral block	Experimental	Sciatic block with or without femoral block performed on the patient with 3mg/kg of ropivacaine	Procedure: Sciatic with or without femoral block
Spinal anaesthesia	Active Comparator	Spinal anaesthesia will be performed on the patient with heavy marcaine 0.5% up to 3mls	Procedure: Spinal anaesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sciatic with or without femoral block	Procedure	Sciatic with or without femoral block performed either with ultrasound and/or nerve stimulator on the patient with 3mg/kg of ropivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure or heart rate changes more than 30% of baseline after spinal or block is considered significant	haemodymic checks were performed at intervals up to 60 minutes after block or spinal	60 minutes

Secondary Outcomes

Measure	Description	Time Frame
S-LANSS score in who receive FSNB versus SAB.	S-LANSS score were obtained at 1 day and 3 months after surgery	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic patients with diabetic foot ulcer undergoing diabetic foot surgery below the knee

Exclusion Criteria:

Refuse spinal or regional anaesthesia
Uncooperative patients
Patients with contraindication for FSNB or SAB
Patients with known allergy to local anaesthetics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chew Yin Wang, MBChB	University of Malaya	Study Director
Hou Yee Lai, MBBS	University of Malaya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Malaya Medical Centre		Kuala Lumpur	Kuala Lumpur	52200	Malaysia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29196938	Derived	Lai HY, Foo LL, Lim SM, Yong CF, Loh PS, Chaw SH, Hasan MS, Wang CY. The hemodynamic and pain impact of peripheral nerve block versus spinal anesthesia in diabetic patients undergoing diabetic foot surgery. Clin Auton Res. 2020 Feb;30(1):53-60. doi: 10.1007/s10286-017-0485-8. Epub 2017 Dec 1.

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia