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Safety and Efficacy of Three Local Block Techniques for Diabetic Foot Surgery

Primary Purpose

Anesthesia, Regional

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sciatic nerve block
ankle block
Bupivacaine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Regional

Eligibility Criteria

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

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) II and III
  • Co-operative
  • Diabetic patients
  • Scheduled for various types of elective diabetic unilateral foot operations

Exclusion Criteria:

  • Patients suffering psychiatric neurological or neuromuscular disorders.
  • Allergy to local anesthetics used.
  • Infection at the block site.
  • Sever renal and hepatic impairment.
  • Patients receiving chronic analgesic therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    sciatic nerve block

    ankle block

    combined popliteal and ankle block

    Arm Description

    ultrasound guided sciatic nerve block by injecting 30ml of 0.5% bupivacaine and visualized circumferentially spreading around the sciatic nerve

    ankle block performed by injecting 20 ml of 0.5% bupivacaine in equal amounts around the five major nerves supplying the foot

    combined block performed by the use of 20 ml of 0.25% bupivacaine for sciatic nerve block followed by the ankle block with use of 20 ml of 0.5% bupivacaine both in the same manner as other two groups.

    Outcomes

    Primary Outcome Measures

    failure rate
    number of patients converted to general anesthesia

    Secondary Outcome Measures

    The onset of sensory block
    Loss of sensation to pin- prick
    The onset of motor block
    complete inability to move the foot
    duration of sensory block
    duration till return in any sensation in the distribution of blocked nerve
    Duration of motor blockade
    duration till return of motor function

    Full Information

    First Posted
    May 10, 2017
    Last Updated
    June 13, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03155568
    Brief Title
    Safety and Efficacy of Three Local Block Techniques for Diabetic Foot Surgery
    Official Title
    Safety and Efficacy of Single Ankle, Single Popliteal or Combined Ankle and Popliteal Block for Diabetic Foot Surgery: A Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 15, 2017 (Anticipated)
    Primary Completion Date
    November 1, 2017 (Anticipated)
    Study Completion Date
    December 1, 2017 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Diabetic patients suffering diabetic foot disease have sever comorbidities, as hypertension, ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which contribute to a high risk profile for anesthesia. failure rate associated with ankle or popliteal nerve block may be higher than accepted, the study hypothesized that combined ankle and popliteal block may increase the success rate with no added complications.
    Detailed Description
    Diabetic patients suffering diabetic foot disease regularly have sever co-morbidities, they are more liable to hypertension, ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which contribute to a high risk profile for anesthesia according to American society of anesthesiologists patients classification. Anesthetic management for diabetic foot disease surgery is a frequent challenge and should be undertaken with a careful consideration of the anesthetic techniques available. Hazards of general anesthesia is more likely in diabetic patients as they have low reserves to preserve against additional straining factors during general anesthesia consequently, avoiding general anesthesia in this population may be a central concern to ensure optimal peri-operative management following lower limb surgery. Neuraxial anesthesia is complicated by urinary retention, hypotension and postdural puncture headache and backache. In chronic ischemic legs, with multiple and diffuse stenosis in the leg segmental vessels, hypotension can precipitate thrombosis easily. In addition fluid loading and vasopressor administration may not be ideal methods to treat hypotension since end stage renal disease and coronary artery occlusive disease are common in these patients. Relative to central nerve block, peripheral limb blocks are more discriminatory in their action and consequently result in less interference of bladder function and motor impairments. Also with peripheral nerve block, patients do not require postoperative fasting that help in preserving patient glycemic control. Moreover. Nerve block anesthesia has the advantages of improved postoperative pain control and it is more economical reducing hospital and associated expenses. Ankle block alone has high failure rate and require more than usual dose to get effective. In popliteal block larger dose is needed than ankle and there is more time delay. The investigators thought to get the advantages of using local than general anesthesia with combined ankle and popliteal blocks to increase potentiation and decrease doses in diabetic foot surgery. Aim of the study is to compare between single ankle, single popliteal and combined ankle popliteal block in diabetic patients undergoing elective foot surgery to determine block success rate, safety and efficacy to find the method of better outcome and lesser side effects.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sciatic nerve block
    Arm Type
    Active Comparator
    Arm Description
    ultrasound guided sciatic nerve block by injecting 30ml of 0.5% bupivacaine and visualized circumferentially spreading around the sciatic nerve
    Arm Title
    ankle block
    Arm Type
    Active Comparator
    Arm Description
    ankle block performed by injecting 20 ml of 0.5% bupivacaine in equal amounts around the five major nerves supplying the foot
    Arm Title
    combined popliteal and ankle block
    Arm Type
    Active Comparator
    Arm Description
    combined block performed by the use of 20 ml of 0.25% bupivacaine for sciatic nerve block followed by the ankle block with use of 20 ml of 0.5% bupivacaine both in the same manner as other two groups.
    Intervention Type
    Procedure
    Intervention Name(s)
    sciatic nerve block
    Intervention Description
    sciatic nerve block at popliteal fossa
    Intervention Type
    Procedure
    Intervention Name(s)
    ankle block
    Intervention Description
    block of major nerves supplying the foot at the level of the ankle
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Description
    blocking the lower limb nerve supply at the level of the popliteal fossa and ankle using the local anesthetic bupivacaine
    Primary Outcome Measure Information:
    Title
    failure rate
    Description
    number of patients converted to general anesthesia
    Time Frame
    from the time of randomization until 5 days postoperatively
    Secondary Outcome Measure Information:
    Title
    The onset of sensory block
    Description
    Loss of sensation to pin- prick
    Time Frame
    from the time of randomization until 5 days postoperatively
    Title
    The onset of motor block
    Description
    complete inability to move the foot
    Time Frame
    from the time of randomization until 5 days postoperatively
    Title
    duration of sensory block
    Description
    duration till return in any sensation in the distribution of blocked nerve
    Time Frame
    from the time of randomization until 5 days postoperatively
    Title
    Duration of motor blockade
    Description
    duration till return of motor function
    Time Frame
    from the time of randomization until 5 days postoperatively

    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: American Society of Anesthesiologists (ASA) II and III Co-operative Diabetic patients Scheduled for various types of elective diabetic unilateral foot operations Exclusion Criteria: Patients suffering psychiatric neurological or neuromuscular disorders. Allergy to local anesthetics used. Infection at the block site. Sever renal and hepatic impairment. Patients receiving chronic analgesic therapy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    khaled A Abdel-Rahman, MD
    Phone
    +2 088 413201
    Email
    khbaqy@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jehan S Ahmed, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Safety and Efficacy of Three Local Block Techniques for Diabetic Foot Surgery

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