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
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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:
Bupivacaine
Epinephrine
Epinephryl borate
Lidocaine
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sodium Channel Blockers
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014