Back to resultsPOPLITEAL SCIATIC NERVE BLOCK FOR DIABETIC FOOT SURGERIES
Primary Purpose
Diabetic Patient
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bupivacaine
magnesium sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Patient
Eligibility Criteria
Inclusion Criteria:
- (ASA) II or III
- scheduled for diabetic foot surgeries.
Exclusion Criteria:
- Patients who refused the anaesthetic technique,
- whose BMI ≥ 35 kg/ m2,
- unable to properly describe postoperative pain to investigator (dementia, delirium, psychiatric and neurological disorders),
- patients with coagulopathy, skin infection at the site of injection,
- preoperative use of opioid or non-steroidal anti-inflammatory drugs,
- allergy or contraindication to studied medication
Sites / Locations
- rehab Abd Elaziz
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
group B
group BM
Arm Description
28ml of 0.25% bupivacaine and 2ml normal saline
received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.
Outcomes
Primary Outcome Measures
duration of postoperative analgesia
evaluate the effects of adding magnesium sulfate to bupivacaine versus bupivacaine alone in popliteal sciatic nerve block with ultrasound guidance for diabetic foot surgeries as regards the duration of postoperative analgesia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04903743
Brief Title
POPLITEAL SCIATIC NERVE BLOCK FOR DIABETIC FOOT SURGERIES
Official Title
ULTRASOUND GUIDED POPLITEAL SCIATIC NERVE BLOCK USING BUPIVACAINE ALONE OR COMBINED WITH MAGNESIUM SULFATE FOR DIABETIC FOOT SURGERIES
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
June 20, 2021 (Anticipated)
Study Completion Date
July 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Popliteal Sciatic nerve block is a regional technique that provides safe and reliable perioperative anesthesia and analgesia of lower leg and foot used in diabetic patients. Different additives have been used with local anaesthetics to achieve dense and prolonged block. Magnesium sulfate possesses analgesic properties owing to its effect on NMDA receptors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Patient
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group B
Arm Type
Placebo Comparator
Arm Description
28ml of 0.25% bupivacaine and 2ml normal saline
Arm Title
group BM
Arm Type
Active Comparator
Arm Description
received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
group B received 28ml of 0.25% bupivacaine and 2ml normal saline
Intervention Type
Drug
Intervention Name(s)
magnesium sulfate
Intervention Description
group BM received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.
Primary Outcome Measure Information:
Title
duration of postoperative analgesia
Description
evaluate the effects of adding magnesium sulfate to bupivacaine versus bupivacaine alone in popliteal sciatic nerve block with ultrasound guidance for diabetic foot surgeries as regards the duration of postoperative analgesia
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(ASA) II or III
scheduled for diabetic foot surgeries.
Exclusion Criteria:
Patients who refused the anaesthetic technique,
whose BMI ≥ 35 kg/ m2,
unable to properly describe postoperative pain to investigator (dementia, delirium, psychiatric and neurological disorders),
patients with coagulopathy, skin infection at the site of injection,
preoperative use of opioid or non-steroidal anti-inflammatory drugs,
allergy or contraindication to studied medication
Facility Information:
Facility Name
rehab Abd Elaziz
City
Alexandria
ZIP/Postal Code
000000
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
POPLITEAL SCIATIC NERVE BLOCK FOR DIABETIC FOOT SURGERIES
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