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

Safety and Efficacy of Single Ankle, Single Popliteal or Combined Ankle and Popliteal Block for Diabetic Foot Surgery: A Comparative Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03155568
Enrollment
90
Registered
2017-05-16
Start date
2017-06-15
Completion date
2017-12-01
Last updated
2017-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Regional

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.

Interventions

PROCEDUREsciatic nerve block

sciatic nerve block at popliteal fossa

PROCEDUREankle block

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

DRUGBupivacaine

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
failure ratefrom the time of randomization until 5 days postoperativelynumber of patients converted to general anesthesia

Secondary

MeasureTime frameDescription
The onset of sensory blockfrom the time of randomization until 5 days postoperativelyLoss of sensation to pin- prick
The onset of motor blockfrom the time of randomization until 5 days postoperativelycomplete inability to move the foot
duration of sensory blockfrom the time of randomization until 5 days postoperativelyduration till return in any sensation in the distribution of blocked nerve
Duration of motor blockadefrom the time of randomization until 5 days postoperativelyduration till return of motor function

Contacts

Primary Contactkhaled A Abdel-Rahman, MD
khbaqy@gmail.com+2 088 413201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026