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

NCT02727348 | Completed

• 1 other identifier: 201401-0658
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

femoral sciatic block spinal diabetic foot haemodynamic pain

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• S-LANSS score in who receive FSNB versus SAB.

  3 months

Study Arms (2)

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

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

Sciatic block with or without femoral block

Spinal anaesthesia PROCEDURE

Spinal anaesthesia with up to 3mls of 0.5% bupivacaine

Spinal anaesthesia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 52200, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 29196938 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Chew Yin Wang, MBChB

  University of Malaya

  STUDY DIRECTOR

• Hou Yee Lai, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: April 4, 2016
• Study Start: May 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 4, 2016

Record last verified: 2016-03

Locations

MY (1)