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

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ClinicalTrials.gov Identifier: NCT03155568
Recruitment Status : Unknown
Verified May 2017 by Khaled Abdel-Baky Abdel-Rahman, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2017
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Khaled Abdel-Baky Abdel-Rahman, Assiut University

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.


Condition or disease Intervention/treatment Phase
Anesthesia, Regional Procedure: sciatic nerve block Procedure: ankle block Drug: Bupivacaine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Single Ankle, Single Popliteal or Combined Ankle and Popliteal Block for Diabetic Foot Surgery: A Comparative Study
Estimated Study Start Date : June 15, 2017
Estimated Primary Completion Date : November 1, 2017
Estimated Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Active Comparator: sciatic nerve block
ultrasound guided sciatic nerve block by injecting 30ml of 0.5% bupivacaine and visualized circumferentially spreading around the sciatic nerve
Procedure: sciatic nerve block
sciatic nerve block at popliteal fossa

Drug: Bupivacaine
blocking the lower limb nerve supply at the level of the popliteal fossa and ankle using the local anesthetic bupivacaine

Active Comparator: ankle block
ankle block performed by injecting 20 ml of 0.5% bupivacaine in equal amounts around the five major nerves supplying the foot
Procedure: ankle block
block of major nerves supplying the foot at the level of the ankle

Drug: Bupivacaine
blocking the lower limb nerve supply at the level of the popliteal fossa and ankle using the local anesthetic bupivacaine

Active Comparator: combined popliteal and ankle block
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.
Procedure: sciatic nerve block
sciatic nerve block at popliteal fossa

Procedure: ankle block
block of major nerves supplying the foot at the level of the ankle

Drug: Bupivacaine
blocking the lower limb nerve supply at the level of the popliteal fossa and ankle using the local anesthetic bupivacaine




Primary Outcome Measures :
  1. failure rate [ Time Frame: from the time of randomization until 5 days postoperatively ]
    number of patients converted to general anesthesia


Secondary Outcome Measures :
  1. The onset of sensory block [ Time Frame: from the time of randomization until 5 days postoperatively ]
    Loss of sensation to pin- prick

  2. The onset of motor block [ Time Frame: from the time of randomization until 5 days postoperatively ]
    complete inability to move the foot

  3. duration of sensory block [ Time Frame: from the time of randomization until 5 days postoperatively ]
    duration till return in any sensation in the distribution of blocked nerve

  4. Duration of motor blockade [ Time Frame: from the time of randomization until 5 days postoperatively ]
    duration till return of motor function



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155568


Contacts
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Contact: khaled A Abdel-Rahman, MD +2 088 413201 khbaqy@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Jehan S Ahmed, MD Assiut University

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Responsible Party: Khaled Abdel-Baky Abdel-Rahman, lecturer of anesthesia and intensive care, Assiut University
ClinicalTrials.gov Identifier: NCT03155568     History of Changes
Other Study ID Numbers: IRB00008718/ref.no2015
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents