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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03155568
Other study ID # IRB00008718/ref.no2015
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 10, 2017
Last updated June 13, 2017
Start date June 15, 2017
Est. completion date December 1, 2017

Study information

Verified date May 2017
Source Assiut University
Contact khaled A Abdel-Rahman, MD
Phone +2 088 413201
Email khbaqy@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date December 1, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
sciatic nerve block
sciatic nerve block at popliteal fossa
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary failure rate number of patients converted to general anesthesia from the time of randomization until 5 days postoperatively
Secondary The onset of sensory block Loss of sensation to pin- prick from the time of randomization until 5 days postoperatively
Secondary The onset of motor block complete inability to move the foot from the time of randomization until 5 days postoperatively
Secondary duration of sensory block duration till return in any sensation in the distribution of blocked nerve from the time of randomization until 5 days postoperatively
Secondary Duration of motor blockade duration till return of motor function from the time of randomization until 5 days postoperatively
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