To Compare lidocaine2%/Clonidine in Combination, With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DR. Jassim Rauf, Cork University Hospital
ClinicalTrials.gov Identifier:
NCT01759524
First received: December 27, 2012
Last updated: November 17, 2013
Last verified: November 2013
  Purpose

Clonidine as an adjuvant to local anaesthetics prolongs the postoperative analgesia. It is predominantly an alpha 2 agonist, but does have some alpha 1 activity. Clonidine alone produces analgesia. When administered centrally its effects are predominantly due to its alpha 2 activity. When administered peripherally it prolongs the analgesia through its vasoconstrictor effects and by reducing the clearance of local anaesthetic. Another possibility is that it prolongs analgesia of peripheral nerve blocks due to a hyperpolarisation current .Clonidine has been used successfully both for upper and lower limb blocks. Studies of clonidine for lower limb blocks have produced equivocal results . A major concern with the lower limb blocks is the risk of falls associated with prolonged motor blockade during early mobilisation. Clonidine has been shown to intensify and prolong the motor blockade produced by long acting local anaesthetics. Lidocaine when used in combination with clonidine can increase the duration of analgesia to 8-18 hrs. Greater doses of clonidine are associated with longer analgesia but with more side effects. Clonidine in a dose of 90 mcg administered with local anaesthetics can produce analgesia for up to 10 hrs with minimal side effects. The aim of this study is to compare lidocaine 2% + clonidine 1.5mcg/kg with bupivacaine alone in terms of block selectivity for combined sciatic -saphenous nerve block in patients under going semi elective foot/ankle procedures.


Condition Intervention Phase
Bimalleolar Fractures of the Ankle.
Sciatic Nerve Block.
Saphenous Nerve Block.
Post Operative Analgesia Duration.
Drug: Bupivacaine
Drug: Lidocaine
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: To Compare lidocaine2%/Clonidine in Combination With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade

Resource links provided by NLM:


Further study details as provided by Cork University Hospital:

Primary Outcome Measures:
  • Duration of postoperative sensory and motor block. [ Time Frame: 36 hours. ] [ Designated as safety issue: No ]
    Postoperative analgesia/duration of block will be assessed at 4,6 8, 10,12,16 hrs or until complete recovery of sensation to cold spray upto 36 hours.


Secondary Outcome Measures:
  • Onset time of block. [ Time Frame: every 5 minutes upto 40 minutes ] [ Designated as safety issue: No ]

    After completion of the two blocks the effect will be assessed every 5 minutes for onset time defined as the time from withdrawal of needle (t0) to complete loss of sensation in the sensory dermatomes of both sciatic and saphenous nerve.

    The sensory level will be assessed on toes and forefoot due to post operative cast restricted access to full tibial and peroneal nerve dermatomes.

    Motor block assessment will carried out using bromage and modified bromage scale for tibial and peroneal nerve



Enrollment: 30
Study Start Date: October 2011
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group L
40 mls of 2% lidocaine + 1.5 mcg/kg will be drawn up by an attending anaesthetist to blind the operator. Patients in this group will receive an ultra sound guided sciatic nerve block , 3 cm proximal to the nerve bifurcation, with 25 mls of the above mentioned solution and an ultra sound guided saphenous nerve block in the midthigh just lateral to the profunda femoris artery with 15 mls of the above mentioned solution.
Drug: Lidocaine
Other Name: 2% lidocaine + 1.5 mcg/kg clonidine
Active Comparator: Group B
40 mls of 0.5% bupivacaine will be drawn up by an attending anaesthetist to blind the operator. Patients in this group will receive an ultra sound guided sciatic nerve block , 3 cm proximal to the nerve bifurcation, with 25 mls of the above mentioned solution and an ultra sound guided saphenous nerve block in the midthigh just lateral to the profunda femoris artery with 15 mls of the above mentioned solution.
Drug: Bupivacaine
Other Name: 0.5% bupivacaine, marcaine.

  Eligibility

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

Inclusion Criteria:

  • ASA 1-3 patients scheduled to undergo semi elective ankle/foot surgery with regional anaesthesia will be recruited.

Exclusion Criteria:

  • patient refusal,
  • allergy to local anaesthetics,
  • coagulopathy,
  • malignancy or infection at the block performance site,
  • significant peripheral neuropathy or neurologic disorder of the lower extremity or any other contraindication to sciatic and saphenous 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: NCT01759524

Locations
Ireland
Cork University Hospital
Cork, Ireland, 0000
Sponsors and Collaborators
Cork University Hospital
Investigators
Study Chair: George Shorten, FCARCSI 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: NCT01759524     History of Changes
Other Study ID Numbers: JR-786-GS
Study First Received: December 27, 2012
Last Updated: November 17, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by Cork University Hospital:
local anaesthesia
analgesia
bupivacaine
lidocaine
clonidine
sciatic nerve
saphenous nerve

Additional relevant MeSH terms:
Ankle Fractures
Fractures, Bone
Wounds and Injuries
Lidocaine
Bupivacaine
Clonidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 16, 2014