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
About this trial
This is an interventional treatment trial for Anesthesia, Regional
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.
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
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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