Clinical trial NCT01759524: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bimalleolar Fractures of the Ankle.
Sciatic Nerve Block.
Saphenous Nerve Block.
Post Operative Analgesia Duration.
Keywords: local anaesthesia
analgesia
bupivacaine
lidocaine
clonidine
sciatic nerve
saphenous nerve
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Duration of postoperative sensory and motor block.
timeFrame: 36 hours.
Secondary outcomes:
measure: Onset time of block.
timeFrame: every 5 minutes upto 40 minutes
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
Study officials:
affiliation: Cork University Hospital, Cork, Ireland.
name: George Shorten, FCARCSI PhD
role: STUDY_CHAIR
References: