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
Information source: Cork University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bimalleolar Fractures of the Ankle.; Sciatic Nerve Block.; Saphenous Nerve Block.; Post Operative Analgesia Duration.
Intervention: Bupivacaine (Drug); Lidocaine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Cork University Hospital Official(s) and/or principal investigator(s): George Shorten, FCARCSI PhD, Study Chair, Affiliation: Cork University Hospital, Cork, Ireland.
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Duration of postoperative sensory and motor block.
Secondary outcome: Onset time of block.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Cork University Hospital, Cork 0000, Ireland
Additional Information
Starting date: October 2011
Last updated: November 17, 2013
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