Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DR. Jassim Rauf, Cork University Hospital
ClinicalTrials.gov Identifier:
NCT01756443
First received: December 20, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a better safety profile as the injection of local anaesthetic is performed under direct vision. This has allowed a reduction of the amount of local anaesthetic injected as compared to peripheral nerve stimulation technique . Blockade of sciatic nerve combined with saphenous nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various combinations of local anaesthetics have been used to provide optimal blockade . A mixture of lidocaine with a long acting local anaesthetic is commonly used. This provides a rapid onset of blockade, but of a consistently shorter duration compared to a long acting local anaesthetic alone. We hypothesize that sequential perineural injection of lidocaine and bupivacaine provides similar onset but a longer duration of sensory block compared to the same dose and volume of local anaesthetic mixed in advance.


Condition Intervention Phase
Open Reduction Internal Fixation(ORIF) of Lateral Malleolus
Drug: 2% lidocaine/adrenaline and 0.5% bupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine. A Double Blinded Randomised Controlled Prospective Study

Resource links provided by NLM:


Further study details as provided by Cork University Hospital:

Primary Outcome Measures:
  • Postoperative analgesia/duration of block [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • onset of block [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
    the block will be assessed every 5 minutes from the time of needle withdrawal till complete loss of sensation to touch.


Enrollment: 40
Study Start Date: August 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Premixed group
Patients will receive sciatic nerve block with premixed 7.5 mls of 2% lidocaine/adrenaline and 7.5 mls of 0.5% bupivacaine followed by an interval of 90 seconds with an injection of same amount of both drugs.
Drug: 2% lidocaine/adrenaline and 0.5% bupivacaine
Experimental: Sequential Group
Patients will receive a sciatic nerve block with 15 mls of 2% lidocaine/adrenaline followed by an interval of 90 seconds with 15 mls of 0.5% bupivacaine.
Drug: 2% lidocaine/adrenaline and 0.5% bupivacaine

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ASA 1 - 3 status
  • scheduled to undergo semi-elective ankle/foot surgery under regional anaesthesia +/- sedation/opioid free general anaesthesia will be recruited

Exclusion Criteria:

  • Patients having surgery on the medial aspect of the ankle/ foot
  • allergy to local anaesthetics
  • coagulopathy
  • malignancy or infection in the popliteal area
  • significant peripheral neuropathy
  • neurologic disorder of the lower extremity
  • any other contraindication to sciatic nerve block
  • pregnancy
  • history of alcohol or drug dependency/abuse (defined as >40 IU/week)
  • a history of significant cognitive or psychiatric disorder that may affect patient assessment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756443

Locations
Ireland
Cork University Hospital
Cork, Ireland, 0000
Sponsors and Collaborators
Cork University Hospital
Investigators
Principal Investigator: Gabriella Iohom, MB, Phd Cork University Hospital, Cork, Ireland
  More Information

No publications provided

Responsible Party: DR. Jassim Rauf, Clinical Research/ Peripheral Nerve Blocks Fellow., Cork University Hospital
ClinicalTrials.gov Identifier: NCT01756443     History of Changes
Other Study ID Numbers: JR-786-GI, SQ-PM-40
Study First Received: December 20, 2012
Last Updated: December 6, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by Cork University Hospital:
sciatic nerve block
ORIF lateral malleolus
sequential injection
premixed injection
local anaesthetics

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Lidocaine
Bupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on April 17, 2014