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

NCT03155568 | Unknown DMC

• 1 other identifier: IRB00008718/ref.no2015
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia, Regional

Outcome Measures

Primary Outcomes (1)

• failure rate

  number of patients converted to general anesthesia

  from the time of randomization until 5 days postoperatively

Secondary Outcomes (4)

• The onset of sensory block

  from the time of randomization until 5 days postoperatively

• The onset of motor block

  from the time of randomization until 5 days postoperatively

• duration of sensory block

  from the time of randomization until 5 days postoperatively

• Duration of motor blockade

  from the time of randomization until 5 days postoperatively

Study Arms (3)

sciatic nerve block

ACTIVE COMPARATOR

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

Procedure: sciatic nerve block; Drug: Bupivacaine

ankle block

ACTIVE COMPARATOR

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

Procedure: ankle block; Drug: Bupivacaine

combined popliteal and ankle block

ACTIVE COMPARATOR

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; Procedure: ankle block; Drug: Bupivacaine

Interventions

sciatic nerve block PROCEDURE

sciatic nerve block at popliteal fossa

combined popliteal and ankle block; sciatic nerve block

ankle block PROCEDURE

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

ankle block; combined popliteal and ankle block

Bupivacaine DRUG

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

ankle block; combined popliteal and ankle block; sciatic nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) II and III
• Co-operative
• Diabetic patients
• Scheduled for various types of elective diabetic unilateral foot operations

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jehan S Ahmed, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

khaled A Abdel-Rahman, MD

CONTACT

+2 088 413201; khbaqy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 16, 2017
• Study Start: June 15, 2017
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 15, 2017

Record last verified: 2017-05