Pain, Acute Clinical Trial
Official title:
SOFT Block Versus Spinal Anesthesia in Patients Undergoing Surgery for Fixation of Open Tibial Fractures Using Ilizarov External Fixator
Verified date | January 2019 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 107 |
Est. completion date | January 10, 2019 |
Est. primary completion date | January 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 57 Years |
Eligibility |
Inclusion Criteria: - 35 to 57 years old - ASA I,II - BMI<30 - fixation of open tibial fractures using Ilizarov external fixator - Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain shams university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Review of medical records for postoperative complications | persistent parasthesia | 48 hours after the procedure | |
Secondary | Failure of the block | general anesthesia will be required to complete surgery. | 50 minutes |
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