Comparison of effect of anesthesia with bupivacaine and fentanyl vs levobupivacaine and fentanyl in leg surgeries

Comparison of subarachnoid block using hyperbaric levobupivacaine plus fentanyl vs hyperbaric bupivacaine plus fentanyl in elective lower limb orthopedic procedures, a randomized controlled study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062376

Enrollment

Registered

2024-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: M96-M96- Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Hyperbaric Levobupivacaine: 2.5 ml Hyperbaric levobupivacaine with 25 mcg fentanyl through spinal anesthesia using a 25G spinal needle administered over 15 seconds Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who have given informed written consent 2. Patients of ASA 1 and 2 3. Age 18-60 years 4. Weight 50-80 kg 5. Height 150-180 cm 6. Elective lower limb orthopedic procedures

Exclusion criteria

Exclusion criteria: a. Patient refusal b. Infection c. Coagulopathy d. Deformity of spine e. Patients allergic to local anesthetic drugs f. Patients with neurological deficit g. Patients on chronic pain medication h. Pregnant patients i. Bilateral lower limb procedures Post inclusion-exclusion criteria a. Prolongation of surgery beyond 3 hours b. Failed spinal anaesthesia c. Excessive bleeding

Design outcomes

Primary

Measure	Time frame
To determine the difference in the duration of analgesia between the two groups.Timepoint: Intraoperatively every 2 minutes for 10 minutes, then every 10 minutes Postoperatively every 4 hours till 24 hours	—

Secondary

Measure	Time frame
To assess complicationsTimepoint: Throughout the surgery and 24 hours postoperatively;To compare postoperative analgesic requirement between the two groupsTimepoint: Postoperatively every 4 hours till 24 hours;To compare the difference in mean score of intraoperative quality of anesthesiaTimepoint: At the end of the surgery;To determine the time of onset of complete motor blockTimepoint: After administering the spinal anesthesia;To determine the time of onset of sensory block (T10)Timepoint: After administering the spinal anesthesia	—

Measure

Time frame

To assess complicationsTimepoint: Throughout the surgery and 24 hours postoperatively;To compare postoperative analgesic requirement between the two groupsTimepoint: Postoperatively every 4 hours till 24 hours;To compare the difference in mean score of intraoperative quality of anesthesiaTimepoint: At the end of the surgery;To determine the time of onset of complete motor blockTimepoint: After administering the spinal anesthesia;To determine the time of onset of sensory block (T10)Timepoint: After administering the spinal anesthesia

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Countries

India

Contacts

Public ContactDr Muthyala Harshini

Nizams institute of medical sciences

njonnavithula@gmail.com9849422749

Outcome results

None listed

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