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

NCT01759524 | Completed Phase 4

• 1 other identifier: JR-786-GS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative sensory and motor block.

  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.

  36 hours.

Secondary Outcomes (1)

• Onset time of block.

  every 5 minutes upto 40 minutes

Study Arms (2)

Group L

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

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

Interventions

Bupivacaine DRUG

Also known as: 0.5% bupivacaine, marcaine.

Group B

Lidocaine DRUG

Also known as: 2% lidocaine + 1.5 mcg/kg clonidine

Group L

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Cork University Hospital

Cork, 0000, Ireland

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Lidocaine; Clonidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• George Shorten, FCARCSI PhD

  Cork University Hospital, Cork, Ireland.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research/ Peripheral Nerve Blocks Fellow.

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: January 3, 2013
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

IE (1)