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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

Primary Purpose

Bimalleolar Fractures of the Ankle., Sciatic Nerve Block., Saphenous Nerve Block.

Status
Completed
Phase
Phase 4
Locations
Ireland
Study Type
Interventional
Intervention
Bupivacaine
Lidocaine
Sponsored by
Cork University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bimalleolar Fractures of the Ankle. focused on measuring local anaesthesia, analgesia, bupivacaine, lidocaine, clonidine, sciatic nerve, saphenous nerve

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cork University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group L

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Onset time of block.
After completion of the two blocks the effect will be assessed every 5 minutes for onset time defined as the time from withdrawal of needle (t0) to complete loss of sensation in the sensory dermatomes of both sciatic and saphenous nerve. The sensory level will be assessed on toes and forefoot due to post operative cast restricted access to full tibial and peroneal nerve dermatomes. Motor block assessment will carried out using bromage and modified bromage scale for tibial and peroneal nerve

Full Information

First Posted
December 27, 2012
Last Updated
November 17, 2013
Sponsor
Cork University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01759524
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cork University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
0.5% bupivacaine, marcaine.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
2% lidocaine + 1.5 mcg/kg clonidine
Primary Outcome Measure Information:
Title
Duration of postoperative sensory and motor block.
Description
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.
Time Frame
36 hours.
Secondary Outcome Measure Information:
Title
Onset time of block.
Description
After completion of the two blocks the effect will be assessed every 5 minutes for onset time defined as the time from withdrawal of needle (t0) to complete loss of sensation in the sensory dermatomes of both sciatic and saphenous nerve. The sensory level will be assessed on toes and forefoot due to post operative cast restricted access to full tibial and peroneal nerve dermatomes. Motor block assessment will carried out using bromage and modified bromage scale for tibial and peroneal nerve
Time Frame
every 5 minutes upto 40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA 1-3 patients scheduled to undergo semi elective ankle/foot surgery with regional anaesthesia will be recruited. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Shorten, FCARCSI PhD
Organizational Affiliation
Cork University Hospital, Cork, Ireland.
Official's Role
Study Chair
Facility Information:
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
0000
Country
Ireland

12. IPD Sharing Statement

Learn more about this trial

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

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