Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine

Phase 4

Completed

• Conditions: Open Reduction Internal Fixation(ORIF) of Lateral Malleolus
• Interventions: Drug: 2% lidocaine/adrenaline and 0.5% bupivacaine

• Registration Number: NCT01756443
• Lead Sponsor: Cork University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-26
• Study First Posted: 2012-12-27
• Study Completion: 2013-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-06
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premixed group	2% lidocaine/adrenaline and 0.5% bupivacaine	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.
Sequential Group	2% lidocaine/adrenaline and 0.5% bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia/duration of block	24 hours

Secondary Outcome Measures

Name	Time	Method
onset of block	40 minutes	the block will be assessed every 5 minutes from the time of needle withdrawal till complete loss of sensation to touch.

Trial Locations

Locations (1)

Cork University Hospital; 🇮🇪 Cork, Ireland