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

Anesthesia, Regional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03155568
• Other study ID #: IRB00008718/ref.no2015
• 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
• 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.

Related Conditions & MeSH terms

• Anesthesia, Regional
• Diabetic Foot

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