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Clinical Trials/NCT01756443
NCT01756443
Completed
Phase 4

Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine. A Double Blinded Randomised Controlled Prospective Study

Cork University Hospital1 site in 1 country40 target enrollmentAugust 2011

Overview

Phase
Phase 4
Intervention
2% lidocaine/adrenaline and 0.5% bupivacaine
Conditions
Open Reduction Internal Fixation(ORIF) of Lateral Malleolus
Sponsor
Cork University Hospital
Enrollment
40
Locations
1
Primary Endpoint
Postoperative analgesia/duration of block
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a better safety profile as the injection of local anaesthetic is performed under direct vision. This has allowed a reduction of the amount of local anaesthetic injected as compared to peripheral nerve stimulation technique . Blockade of sciatic nerve combined with saphenous nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various combinations of local anaesthetics have been used to provide optimal blockade . A mixture of lidocaine with a long acting local anaesthetic is commonly used. This provides a rapid onset of blockade, but of a consistently shorter duration compared to a long acting local anaesthetic alone. We hypothesize that sequential perineural injection of lidocaine and bupivacaine provides similar onset but a longer duration of sensory block compared to the same dose and volume of local anaesthetic mixed in advance.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
January 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

DR. Jassim Rauf

Clinical Research/ Peripheral Nerve Blocks Fellow.

Cork University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with ASA 1 - 3 status
  • scheduled to undergo semi-elective ankle/foot surgery under regional anaesthesia +/- sedation/opioid free general anaesthesia will be recruited

Exclusion Criteria

  • Patients having surgery on the medial aspect of the ankle/ foot
  • allergy to local anaesthetics
  • coagulopathy
  • malignancy or infection in the popliteal area
  • significant peripheral neuropathy
  • neurologic disorder of the lower extremity
  • any other contraindication to sciatic 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

Arms & Interventions

Premixed group

Patients will receive sciatic nerve block with premixed 7.5 mls of 2% lidocaine/adrenaline and 7.5 mls of 0.5% bupivacaine followed by an interval of 90 seconds with an injection of same amount of both drugs.

Intervention: 2% lidocaine/adrenaline and 0.5% bupivacaine

Sequential Group

Patients will receive a sciatic nerve block with 15 mls of 2% lidocaine/adrenaline followed by an interval of 90 seconds with 15 mls of 0.5% bupivacaine.

Intervention: 2% lidocaine/adrenaline and 0.5% bupivacaine

Outcomes

Primary Outcomes

Postoperative analgesia/duration of block

Time Frame: 24 hours

Secondary Outcomes

  • onset of block(40 minutes)

Study Sites (1)

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