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SOFT Block Versus Spinal Anesthesia in Patientsusing Ilizarov External Fixator

NCT03450798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2019-01-24

No results posted yet for this study

Summary

Peripheral nerve block is an ideal choice for lower limb surgery because of the peripheral site of the surgical procedure and the ability to block pain pathways at multiple levels. On the contrary to other anesthetic techniques, as spinal or general anesthesia, properly performed peripheral nerve blocks bypass adverse events as hemodynamic instability and respiratory complications, properly treat post-operative pain leading to early hospital discharge. Additional advantages of peripheral nerve blocks are that they can be used in patients receiving anti-coagulants or lumbosacral disease in addition to avoidance of airway instrumentation.

Recently, there has been a significant interest in regional anesthesia and peripheral nerve blockade. This is facilitated by a significant advance of the research in this field and availability of better equipment facilitating regional anesthesia.The aim of this study was to assess the efficacy and safety of SOFT block (sciatic-obturator-femoral nerve block technique) in comparison with spinal anesthesia in patients undergoing surgery for fixation of open tibial fractures using Ilizarov external fixator.

Conditions

  • Pain, Acute

Interventions

DEVICE

SOFT block group

needle will be introduced medial to the femoral vein and 3 cm below the skin where 15 mL of bupivacaine 0.25% injected. the obturator nerve, the probe shifted medially, superior to the needle, and directed cranially to the pectineus muscle . Needle withdrawn to the subcutaneous tissue and redirected using out-of-plane toward the deep surface of pectineus, 10 mL of bupivacaine 0.25%will be injected. The sciatic nerve, we use the curvilinear probe, inferior to the needle, and tilted the probe to get the clearest image of the sciatic nerve.The needle will be inserted then withdrawn subcutaneously and directed by an in-plane toward the sciatic nerve deep to the inferior border of the quadratus femoris muscle.20 mL of bupivacaine 0.25% will be injected

DEVICE

spinal anesthesia group

patients will receive spinal anesthesia with hyperbaric bupivacaine 0.5% (7.5-10mg). This will be administered via a 25-G spinal needle at L4-L5 or L3-L4 with the patient in the sitting position under complete aseptic conditions.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Hoda Shokri, MD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
57 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-10
Primary Completion
2019-01-10
Completion
2019-01-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450798 on ClinicalTrials.gov