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

Haemodynamic and Pain Outcomes in Patients Undergoing Diabetic Foot Surgery Performed Under Sciatic Nerve Blocks With or Without Femoral Nerve Block Versus Spinal Anaesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02727348
Enrollment
120
Registered
2016-04-04
Start date
2014-05-31
Completion date
2016-02-29
Last updated
2016-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Keywords

femoral sciatic block spinal diabetic foot haemodynamic pain

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.

Interventions

PROCEDURESciatic with or without femoral block

Sciatic with or without femoral block performed either with ultrasound and/or nerve stimulator on the patient with 3mg/kg of ropivacaine

PROCEDURESpinal anaesthesia

Spinal anaesthesia with up to 3mls of 0.5% bupivacaine

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure or heart rate changes more than 30% of baseline after spinal or block is considered significant60 minuteshaemodymic checks were performed at intervals up to 60 minutes after block or spinal

Secondary

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

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026