Comparison of two methods of Bupivacaine and Fentanyl injection in lower limb fracture surgeries

Comparison of fractionated dose of Bupivacaine and Fentanyl versus bolus dose injection in spinal anesthesia in lower limb fracture surgeries

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180121038462N1

Enrollment

Registered

2018-03-11

Start date

2016-04-08

Completion date

Unknown

Last updated

2018-03-26

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

Conditions

Condition 1: Lower limb fracture surgery. Condition 2: Lower limb fracture surgery. Condition 3: Lower limb fracture surgery. Injuries to the hip and thigh Injuries to the knee and lower leg Injuries to the ankle and foot

Interventions

Intervention 1: Intervention group: Patients in intervention group, will receive half dose of 15 milligram of Bupivacaine 0.5 % and 25 micro gram of Fentanyl at first, and after 45 seconds half the o

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients undergoing surgery for lower limb fractures Age 18 to 50 years old ASA 1 to 2

Exclusion criteria

Exclusion criteria: Patients with absolute spinal anesthesia contraindication Refusal of the patient Localized sepsis Allergy to the anesthetic drugs Patient's inability to maintain position during the procedure Increase ICP Spinal relative contraindications such as myelopathy or peripheral neuropathy Spinal stenosis history of spinal surgery Multiple sclerosis Spina bifida Aortic thrombosis Hypovolemia Hereditary coagulopathies Thromboprofylaxis (ambulatory lung) Systemic infections Patients with a BMI greater than 35 Spinal deformities Patients who did not succeed in spinal anesthesia Patients whose length of operation is longer than their spinal anesthesia length

Design outcomes

Primary

Measure	Time frame
Blood pressure. Timepoint: 24 hours after surgery. Method of measurement: Noninvasive Blood Pressure Amplifier (NIBP).;Heart rate. Timepoint: 24 hours after surgery. Method of measurement: Electrocardiography.;Pruritus. Timepoint: 24 hours after surgery. Method of measurement: Observation.;Urinary retention. Timepoint: 24 hours after surgery. Method of measurement: Observation.;Shivering. Timepoint: 24 hours after surgery. Method of measurement: Observatioon.;Respiratory distress. Timepoint: 24 hours after surgery. Method of measurement: Clinical feature.;Nausea. Timepoint: 24 hours after surgery. Method of measurement: Observation.;Vomiting. Timepoint: 24 hours after surgery. Method of measurement: Observation.;Onset of sensory block. Timepoint: After the injection of anesthetic drug. Method of measurement: Pinprick test.;Onset of motor block. Timepoint: After the injection of anesthetic drug. Method of measurement: Modified bromage scale.;Highest level of sensory block. Timepoint: After the injection of anesthetic drug. Method of measurement: Pinprick test.;Duration of sensory block. Timepoint: After the injection of anesthetic drug. Method of measurement: Modified bromage scale.;Duration of motor block. Timepoint: After the injection of anesthetic drug. Method of measurement: Pinprick test.	—

Measure

Time frame

Blood pressure. Timepoint: 24 hours after surgery. Method of measurement: Noninvasive Blood Pressure Amplifier (NIBP).;Heart rate. Timepoint: 24 hours after surgery. Method of measurement: Electrocardiography.;Pruritus. Timepoint: 24 hours after surgery. Method of measurement: Observation.;Urinary retention. Timepoint: 24 hours after surgery. Method of measurement: Observation.;Shivering. Timepoint: 24 hours after surgery. Method of measurement: Observatioon.;Respiratory distress. Timepoint: 24 hours after surgery. Method of measurement: Clinical feature.;Nausea. Timepoint: 24 hours after surgery. Method of measurement: Observation.;Vomiting. Timepoint: 24 hours after surgery. Method of measurement: Observation.;Onset of sensory block. Timepoint: After the injection of anesthetic drug. Method of measurement: Pinprick test.;Onset of motor block. Timepoint: After the injection of anesthetic drug. Method of measurement: Modified bromage scale.;Highest level of sensory block. Timepoint: After the injection of anesthetic drug. Method of measurement: Pinprick test.;Duration of sensory block. Timepoint: After the injection of anesthetic drug. Method of measurement: Modified bromage scale.;Duration of motor block. Timepoint: After the injection of anesthetic drug. Method of measurement: Pinprick test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactQazale Khaef

Iran University of Medical Sciences

khaef.gh@iums.ac.ir+98 21 86701

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026