Clinical trial NCT03155568: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Regional
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: failure rate
timeFrame: from the time of randomization until 5 days postoperatively
Secondary outcomes:
measure: The onset of sensory block
timeFrame: from the time of randomization until 5 days postoperatively
measure: The onset of motor block
timeFrame: from the time of randomization until 5 days postoperatively
measure: duration of sensory block
timeFrame: from the time of randomization until 5 days postoperatively
measure: Duration of motor blockade
timeFrame: from the time of randomization until 5 days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Jehan S Ahmed, MD
role: STUDY_DIRECTOR
References: