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CompletedNCT01756443Updated Dec 10, 2013

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 Phase 4 interventional study of 2% lidocaine/adrenaline and 0.5% bupivacaine in Open Reduction Internal Fixation(ORIF) of Lateral Malleolus, sponsored by Cork University Hospital. Completed at 1 site in Ireland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-10.

Sponsored by Cork University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Open Reduction Internal Fixation(ORIF) of Lateral Malleolus

Keywords

  • sciatic nerve block
  • ORIF lateral malleolus
  • sequential injection
  • premixed injection
  • local anaesthetics
03

In context

Lead sponsor

Cork University Hospital is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    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.

    Drug: 2% lidocaine/adrenaline and 0.5% bupivacaine

  • Experimental
    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.

    Drug: 2% lidocaine/adrenaline and 0.5% bupivacaine

Interventions

  • Drug2% lidocaine/adrenaline and 0.5% bupivacaine
06

What researchers measure

Primary outcomes

  1. Postoperative analgesia/duration of block

    Time frame: 24 hours

Secondary outcomes

  1. onset of block

    the block will be assessed every 5 minutes from the time of needle withdrawal till complete loss of sensation to touch.

    Time frame: 40 minutes

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Study locations

1 site
  • Cork University Hospital
    Cork, 0000, Ireland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01756443
Lead sponsor
Cork University Hospital
Responsible party
DR. Jassim Rauf (Clinical Research/ Peripheral Nerve Blocks Fellow., Cork University Hospital) — Principal investigator
First posted
Dec 27, 2012
Start date
Aug 2011
Primary completion
Dec 2012
Completion
Jan 2013
Last update
Dec 10, 2013

Study contacts

Gabriella Iohom, MB, Phd
principal investigator · Cork University Hospital, Cork, Ireland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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