A comparison of two drugs used with Spinal Anaesthesia for prostate surgery in Elderly Men to check the better drug between these two drugs in terms of efficacy and pain management.

Comparison of Intrathecal Fentanyl versus Buprenorphine as an adjuvant to 0.5 percent Levobupivacaine Heavy for Spinal Anaesthesia in elderly patients undergoing Transurethral resection of Prostate. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102230

Enrollment

106

Registered

2026-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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: Fentanyl: 2 ml of 0.5% levobupivacaine intrathecally with 15 micrograms fentanyl as an adjuvant. Duration - From the time of administration of spinal anaesthesia till the effects of th

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male patients between 50-85 years of age 2.BMI of 18-30 kg/m2 3.ASA Physical Status I,II,III

Exclusion criteria

Exclusion criteria: 1) Unable to follow simple commands 2) Infection at the site of administration of spinal 3) Raised Intracranial pressure 4) Hypersensitivity to any of the drugs involved 5) Coagulopathy 6) Sepsis

Design outcomes

Primary

Measure	Time frame
1. Time taken for onset of sensory blockade (at T10) 2. Time taken for complete Motor blockade (Bromage scale 3. Time taken for highest level of Analgesia 4. Time taken for 2-segment regression 5. Time taken for sensory(S2-S3) and motor recovery (Bromage scale 0) 6. Duration of postoperative analgesia Timepoint: Sensory blockade and motor blockade at- 1. Baseline 2. Every 2 minutes for first 10 minutes. 3. Every 5 minutes after first 10 minutes till one hour. 4. Immediately post surgery 5. One hour post surgery 6. Two hour post surgery Analgesia at- 1. Baseline 2. After 10 minutes 3. Immediately Post surgery 4. One hour post surgery 5. Two hour post surgery	—

Measure

Time frame

1. Time taken for onset of sensory blockade (at T10) 2. Time taken for complete Motor blockade (Bromage scale 3. Time taken for highest level of Analgesia 4. Time taken for 2-segment regression 5. Time taken for sensory(S2-S3) and motor recovery (Bromage scale 0) 6. Duration of postoperative analgesia Timepoint: Sensory blockade and motor blockade at- 1. Baseline 2. Every 2 minutes for first 10 minutes. 3. Every 5 minutes after first 10 minutes till one hour. 4. Immediately post surgery 5. One hour post surgery 6. Two hour post surgery Analgesia at- 1. Baseline 2. After 10 minutes 3. Immediately Post surgery 4. One hour post surgery 5. Two hour post surgery

—

Secondary

Measure	Time frame
1. Hemodynamic changes 2. Adverse effects if any Timepoint: Baseline & then every 2 minutes for next 10 minutes & then every 5 minutes till one hour of the procedure.	—

Countries

India

Contacts

Public ContactDrLaxmi Shenoy

Manipal Academy of Higher Education

drlaxmishenoy@gmail.com9448911261

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026