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

Primary Purpose

Diabetic Foot

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Sciatic with or without femoral block
Spinal anaesthesia
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring femoral sciatic block spinal diabetic foot haemodynamic pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Malaya Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sciatic block with or without femoral block

Spinal anaesthesia

Arm Description

Sciatic block with or without femoral block performed on the patient with 3mg/kg of ropivacaine

Spinal anaesthesia will be performed on the patient with heavy marcaine 0.5% up to 3mls

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2014
Last Updated
March 29, 2016
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT02727348
Brief Title
Sciatic Nerve Blocks With or Without Femoral Block Versus Spinal Anaesthesia in Patients Undergoing Diabetic Foot Surgery
Official Title
Haemodynamic and Pain Outcomes in Patients Undergoing Diabetic Foot Surgery Performed Under Sciatic Nerve Blocks With or Without Femoral Nerve Block Versus Spinal Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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/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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
femoral sciatic block spinal diabetic foot haemodynamic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sciatic block with or without femoral block
Arm Type
Experimental
Arm Description
Sciatic block with or without femoral block performed on the patient with 3mg/kg of ropivacaine
Arm Title
Spinal anaesthesia
Arm Type
Active Comparator
Arm Description
Spinal anaesthesia will be performed on the patient with heavy marcaine 0.5% up to 3mls
Intervention Type
Procedure
Intervention Name(s)
Sciatic with or without femoral block
Intervention Description
Sciatic with or without femoral block performed either with ultrasound and/or nerve stimulator on the patient with 3mg/kg of ropivacaine
Intervention Type
Procedure
Intervention Name(s)
Spinal anaesthesia
Intervention Description
Spinal anaesthesia with up to 3mls of 0.5% bupivacaine
Primary Outcome Measure Information:
Title
Blood pressure or heart rate changes more than 30% of baseline after spinal or block is considered significant
Description
haemodymic checks were performed at intervals up to 60 minutes after block or spinal
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
S-LANSS score in who receive FSNB versus SAB.
Description
S-LANSS score were obtained at 1 day and 3 months after surgery
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chew Yin Wang, MBChB
Organizational Affiliation
University of Malaya
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hou Yee Lai, MBBS
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
52200
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
29196938
Citation
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.
Results Reference
derived

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

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