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NCT Number: NCT02727348

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Kuala Lumpur, 52200, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

spinal anaesthesia

Procedure

Spinal anaesthesia with up to 3mls of 0.5% bupivacaine

Primary outcomes

  1. Blood pressure or heart rate changes more than 30% of baseline after spinal or block is considered significant

    Time frame: 60 minutes

    haemodymic checks were performed at intervals up to 60 minutes after block or spinal

Secondary outcomes

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

    Time frame: 3 months

    S-LANSS score were obtained at 1 day and 3 months after surgery

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2016
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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