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

NCT ID: NCT03155568

Last Updated: 2017-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2017-12-01

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.

Conditions

Anesthesia, Regional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sciatic nerve block

ultrasound guided sciatic nerve block by injecting 30ml of 0.5% bupivacaine and visualized circumferentially spreading around the sciatic nerve

Group Type: ACTIVE_COMPARATOR

sciatic nerve block

Intervention Type: PROCEDURE

sciatic nerve block at popliteal fossa

Bupivacaine

Intervention Type: DRUG

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

ankle block

ankle block performed by injecting 20 ml of 0.5% bupivacaine in equal amounts around the five major nerves supplying the foot

Group Type: ACTIVE_COMPARATOR

ankle block

Intervention Type: PROCEDURE

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

Bupivacaine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

sciatic nerve block

Intervention Type: PROCEDURE

sciatic nerve block at popliteal fossa

ankle block

Intervention Type: PROCEDURE

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

Bupivacaine

Intervention Type: DRUG

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

Interventions

sciatic nerve block

sciatic nerve block at popliteal fossa

Intervention Type: PROCEDURE

ankle block

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

Intervention Type: PROCEDURE

Bupivacaine

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Khaled Abdel-Baky Abdel-Rahman

lecturer of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jehan S Ahmed, MD

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

khaled A Abdel-Rahman, MD

Role: CONTACT

khbaqy@gmail.com

+2 088 413201

Other Identifiers

IRB00008718/ref.no2015

Identifier Type: -

Identifier Source: org_study_id