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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Regional
• Intervention / Treatment: Procedure: sciatic nerve block; Drug: Bupivacaine; Procedure: ankle block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: khaled A Abdel-Rahman, MD; Phone Number: +2 088 413201; Email: khbaqy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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	Drug: Bupivacaine; blocking the lower limb nerve supply at the level of the popliteal fossa and ankle using the local anesthetic bupivacaine; Procedure: ankle block; block of major nerves supplying the foot at the level of the ankle
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; Drug: Bupivacaine; blocking the lower limb nerve supply at the level of the popliteal fossa and ankle using the local anesthetic bupivacaine; Procedure: ankle block; block of major nerves supplying the foot at the level of the ankle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
failure rate	number of patients converted to general anesthesia	from the time of randomization until 5 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The onset of sensory block	Loss of sensation to pin- prick	from the time of randomization until 5 days postoperatively
The onset of motor block	complete inability to move the foot	from the time of randomization until 5 days postoperatively
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
Duration of motor blockade	duration till return of motor function	from the time of randomization until 5 days postoperatively

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Jehan S Ahmed, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2017
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 14, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB00008718/ref.no2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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