The effect of bupivacaine and ropivacaine on anesthesia and early walking after tibia fracture surgery.

Comparison of the effects of bupivacaine and ropivacaine on block characteristics and early ambulation after tibial fracture repair surgery.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191104045328N42

Enrollment

100

Registered

2025-10-06

Start date

2025-10-12

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Tibia Fracture. Fracture of shaft of tibia

Interventions

Intervention 1: Intervention group: Patients in this group will receive 3 mL of 0.5 % ropivacaine, equivalent to 15 mg (ropivacaine manufactured by Varian Pharmed, Iran). Intervention 2: Intervention

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for tibia fracture surgery Having informed consent to participate in the study Surgery performed by a single surgeon

Exclusion criteria

Exclusion criteria: Having a history of systemic kidney, liver, cardiovascular disease, high blood pressure, diabetes, or malignancy Having a history of chronic opioid or painkiller use Having a known allergies to the study drugs or seasonal allergies

Design outcomes

Primary

Measure	Time frame
Ramsey Score. Timepoint: Recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: By registering the Ramsey Score.;Pain score. Timepoint: Recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: Visual analog scale.;Onset and end of sensory block. Timepoint: After spinal anesthesia and after surgery. Method of measurement: Using the pinprick test.;Onset and end of motor block. Timepoint: After spinal anesthesia and after surgery. Method of measurement: Using the Bromage scale.;Time to ambulation. Timepoint: after spinal anesthesia. Method of measurement: Physical examination.;Intraoperative and postoperative complications. Timepoint: During and after surgery. Method of measurement: Based on cardiac monitoring and vital signs data.	—

Measure

Time frame

Ramsey Score. Timepoint: Recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: By registering the Ramsey Score.;Pain score. Timepoint: Recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: Visual analog scale.;Onset and end of sensory block. Timepoint: After spinal anesthesia and after surgery. Method of measurement: Using the pinprick test.;Onset and end of motor block. Timepoint: After spinal anesthesia and after surgery. Method of measurement: Using the Bromage scale.;Time to ambulation. Timepoint: after spinal anesthesia. Method of measurement: Physical examination.;Intraoperative and postoperative complications. Timepoint: During and after surgery. Method of measurement: Based on cardiac monitoring and vital signs data.

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Secondary

Measure	Time frame
Mean arterial pressure. Timepoint: At the start of surgery and every 15 minutes until the end of surgery, in recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: NIBP monitoring device.;Heart rate. Timepoint: At the start of surgery and every 15 minutes until the end of surgery, in recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: Cardiac monitoring device.;Arterial blood oxygen saturation. Timepoint: At the start of surgery and every 15 minutes until the end of surgery, in recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: Pulse oximetry.	—

Measure

Time frame

Mean arterial pressure. Timepoint: At the start of surgery and every 15 minutes until the end of surgery, in recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: NIBP monitoring device.;Heart rate. Timepoint: At the start of surgery and every 15 minutes until the end of surgery, in recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: Cardiac monitoring device.;Arterial blood oxygen saturation. Timepoint: At the start of surgery and every 15 minutes until the end of surgery, in recovery, and at 2, 4, 6, and 12 hours after surgery. Method of measurement: Pulse oximetry.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Alireza Kamali

Arak University of Medical Sciences

alikamaliir@yahoo.com+98 86 3222 2003

Outcome results

None listed

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