Comparison of two methods midline and lateral of epidural anesthesia in patients undergoing orthopedic surgery in the lower extremities

Comparison of two methods of midline interlaminar and parasagittal interlaminar epidural anesthesia in patients undergoing orthopedic surgery in the lower extremities

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017041615515N2

Enrollment

Registered

2017-05-02

Start date

2016-04-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial shaft fracture. Unspecified fracture of upper end of unspecified tibia

Interventions

Intervention 1: Intervention group: Patients received parasagittal interlaminar of epidural anesthesia. Intervention 2: Control group: Patients received midline interlaminar of epidural anesthesia.

Prevention

Intervention group: Patients received parasagittal interlaminar of epidural anesthesia.

Control group: Patients received midline interlaminar of epidural anesthesia.

Eligibility

Sex/Gender

All

Age

19 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patient candidate for tibial shaft fracture orthopedic surgery; Tibial fracture, which passed 120-90 minute of it; Age more than 18 yr; ASA Class I- II; Signed written informed consent to participate in the study. Exclusion criteria: Pregnant women; Sepsis; Emergency surgeries; Infection at the site of injection; Coagulopathy or other bleeding diathesis; Spinal deformity; Diabetes; Systemic disease and neuropathy; History of surgery on the lumbar spine; Facet joint arthropathy; Cauda equina syndrome and other unstable neurologic deficits; Allergic to contrast or lidocaine.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Blood pressure. Timepoint: Before and after anesthesia to end of surgery. Method of measurement: mmHg.;Heart rate. Timepoint: Before and after anesthesia to end of surgery. Method of measurement: bpm.;Sensory block. Timepoint: After anesthesia to exit of recovery. Method of measurement: Pinprick test.;Motor Block. Timepoint: After anesthesia to exit of recovery. Method of measurement: Bromage score.;Duration of sensory block. Timepoint: After anesthesia. Method of measurement: Minute.;Duration of motor block. Timepoint: After anesthesia. Method of measurement: Minute.;Bradycardia. Timepoint: After anesthesia to end of surgery. Method of measurement: bpm.;Hypotension. Timepoint: After anesthesia to end of surgery. Method of measurement: mmHg.	—

Measure

Time frame

Blood pressure. Timepoint: Before and after anesthesia to end of surgery. Method of measurement: mmHg.;Heart rate. Timepoint: Before and after anesthesia to end of surgery. Method of measurement: bpm.;Sensory block. Timepoint: After anesthesia to exit of recovery. Method of measurement: Pinprick test.;Motor Block. Timepoint: After anesthesia to exit of recovery. Method of measurement: Bromage score.;Duration of sensory block. Timepoint: After anesthesia. Method of measurement: Minute.;Duration of motor block. Timepoint: After anesthesia. Method of measurement: Minute.;Bradycardia. Timepoint: After anesthesia to end of surgery. Method of measurement: bpm.;Hypotension. Timepoint: After anesthesia to end of surgery. Method of measurement: mmHg.

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Secondary

Measure	Time frame
Nausea. Timepoint: After entering the recovery. Method of measurement: Ask the patient.;Vomiting. Timepoint: After entering the recovery. Method of measurement: Ask the patient.;Headache. Timepoint: After entering the recovery. Method of measurement: Ask the patient.;Bleeding. Timepoint: After entering the recovery. Method of measurement: The amount collected in the drain.;Urinary retention. Timepoint: After entering the recovery. Method of measurement: Urinary catheter.	—

Measure

Time frame

Nausea. Timepoint: After entering the recovery. Method of measurement: Ask the patient.;Vomiting. Timepoint: After entering the recovery. Method of measurement: Ask the patient.;Headache. Timepoint: After entering the recovery. Method of measurement: Ask the patient.;Bleeding. Timepoint: After entering the recovery. Method of measurement: The amount collected in the drain.;Urinary retention. Timepoint: After entering the recovery. Method of measurement: Urinary catheter.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Masoud Hashemi

Akhtar Hospital

Dr.hashemi@sbmu.ac.ir+98 21 2261 2252

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 21, 2026