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

NCT ID: NCT01756443

Last Updated: 2013-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-01-31

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.

Conditions

Open Reduction Internal Fixation(ORIF) of Lateral Malleolus

Keywords

sciatic nerve block; ORIF lateral malleolus; sequential injection; premixed injection; local anaesthetics

Study Design

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

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

2% lidocaine/adrenaline and 0.5% bupivacaine

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

2% lidocaine/adrenaline and 0.5% bupivacaine

Intervention Type: DRUG

Interventions

2% lidocaine/adrenaline and 0.5% bupivacaine

Intervention Type: DRUG

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

• 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

Gabriella Iohom, MB, Phd

Role: PRINCIPAL_INVESTIGATOR

Cork University Hospital, Cork, Ireland

Locations

Cork University Hospital

Cork, , Ireland

Countries

Ireland

Other Identifiers

SQ-PM-40

Identifier Type: -

Identifier Source: secondary_id

JR-786-GI

Identifier Type: -

Identifier Source: org_study_id