SOFT Block Versus Spinal Anesthesia in Patientsusing Ilizarov External Fixator

NCT03450798 | Completed

• 1 other identifier: FWA00001785
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• T- test of the recovery time(duration of analgesia)mean±SD

  It is the time from the end of local anaesthetic injection to complete resolution of sensory block

  3-12 hours

Secondary Outcomes (2)

• Review of medical records for postoperative complications

  48 hours after the procedure

• Failure of the block

  50 minutes

Study Arms (2)

SOFT block group

ACTIVE COMPARATOR

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 Needle withdrawn to the subcutaneous tissue and redirected using out-of-plane toward the deep surface of pectineus, 10 mL of bupivacaine 0.25%will be injected.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to the needle, and tilted the probe to get the clearest image of the sciatic nerve.The needle will be inserted then withdrawn subcutaneously and directed by an in-plane toward the sciatic nerve deep to the inferior border of the quadratus femoris muscle.20 mL of bupivacaine 0.25% will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: SOFT block group

spinal anesthesia group

SHAM COMPARATOR

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.

Device: spinal anesthesia group

Interventions

SOFT block group DEVICE

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

SOFT block group

spinal anesthesia group DEVICE

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.

spinal anesthesia group

Eligibility Criteria

• Age: 35 Years - 57 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 57 years old
• ASA I,II
• BMI\<30
• fixation of open tibial fractures using Ilizarov external fixator -

You may not qualify if:

• Refusal to participate,
• Inability to communicate with the investigators or hospital staff,
• body mass index\>40 kg/m2
• patients undergoing bilateral surgery,
• History of coagulopathies
• creatinine\>1.5 mg/dL
• American Society of Anesthesia (ASA) III-IV
• Any contraindication to regional anesthesia
• Unstable vital data
• Head or chest trauma will be excluded.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 11566, Egypt

Location

Related Publications (1)

• Shokri H, Kasem AA. Sciatic obturator femoral technique versus spinal anaesthesia in patients undergoing surgery for fixation of open tibial fractures using Ilizarov external fixator. A randomised trial. BMC Anesthesiol. 2020 Jan 4;20(1):4. doi: 10.1186/s12871-019-0920-6.

  PMID: 31901231 DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hoda Shokri, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HShokri

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 1, 2018
• Study Start: February 10, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 5 to 6 months
• Access Criteria: The collected data are coded, tabulated, and statistically analyzed using statistical package for social sciences software, version 17.0 (SPSS Inc., Chicago, Illinois, USA). Descriptive statistics are carried out for numerical parametric data and presented as mean±SD, whereas categorical data are presented as number and percentage. Variables such as demographic data and comorbidities are compared using the χ2-test. A P value less than 0.05 was considered significant.

Locations

EG (1)