Study to compare Bupivacaine heavy, Levobupivacaine plain and Levobupivacaine heavy with Fentanyl (opioid) as an add on drug under spinal anesthesia in Prostate surgery.

A comparative study of low dose Bupivacaine 0.5% (heavy), Levobupivacaine 0.5% (plain) and Levobupivacaine 0.5% (heavy) with Fentanyl as an adjuvant in Transurethral Resection of Prostate surgery: A prospective randomized study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054367

Enrollment

105

Registered

2023-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: Bupivacaine 0.5% heavy with Fentanyl: Bupivacaine 0.5% heavy 1.5 ml with 25 microgram Fentanyl for Transurethral Resection of Prostate surgery under spinal anaesthesia Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: Patient giving consent to participate in study Age between 50-75 years Weight between 45-70 kg ASA grade I and II Patient scheduled for TURP surgeries.

Exclusion criteria

Exclusion criteria: Patients not giving consent to participate in the study. Uncooperative patient ASA grade III and IV Patients with respiratory, cardiovascular, renal diseases, obesity. Neurological disease (multiple sclerosis, symptomatic lumbar herniated disc, spinal stenosis) Coagulopathy Patient with known hypersensitivity to local anaesthetic. Local sepsis or infection

Design outcomes

Primary

Measure	Time frame
Expected prolonged efficacy of Levobupivacaine 0.5% heavy over Bupivacaine 0.5% heavy & Levobupivacaine 0.5% plainTimepoint: 24 hours	—

Secondary

Measure	Time frame
Expected lesser side effects & stable hemodynamic profile with Levobupivacaine 0.5% heavy than Bupivacaine 0.5% heavy and Levobupivacaine 0.5% plainTimepoint: 24 hours	—

Countries

India

Contacts

Public ContactDr Seema Shende

Gajra raja Medical college, Gwalior

drseema26@gmail.com7566439701

Outcome results

None listed

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