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

NCT ID: NCT01759524

Last Updated: 2013-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

Interventions

Bupivacaine

Intervention Type: DRUG

Lidocaine

Intervention Type: DRUG

Other Intervention Names

0.5% bupivacaine, marcaine.; 2% lidocaine + 1.5 mcg/kg clonidine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cork University Hospital

OTHER

Sponsor Role: lead

Responsible Party

DR. Jassim Rauf

Clinical Research/ Peripheral Nerve Blocks Fellow.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Shorten, FCARCSI PhD

Role: STUDY_CHAIR

Cork University Hospital, Cork, Ireland.

Locations

Cork University Hospital

Cork, , Ireland

Countries

Ireland

Other Identifiers

JR-786-GS

Identifier Type: -

Identifier Source: org_study_id