Comparison of effectiveness and hemodynamic stability of making patient sit for 10 mins versus making patient supine directly after subarachnoid block using Levobupivacaine with Fentanyl as an adjunct in Transurethral resection of prostate TURP surgery A randomised comparative study

Comparison of effectiveness and hemodynamic stability of saddle block versus spinal anaesthesia using Levobupivacaine with Fentanyl as an adjuvant in Transurethral resection of prostate surgery A randomised comparative study - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077685

Enrollment

Registered

2024-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: N400- Benign prostatic hyperplasia without lower urinary tract symptoms

Interventions

Intervention1: Subarachnoid Block Group: Under all aseptic & antiseptic precautions spinal anaesthesia will be given in L3–L4 intervertebral space in sitting position in all cases. 23G Quincke’s spina

Eligibility

Inclusion criteria

Inclusion criteria: Weight :50-80 Kg Height : 150-170cm American society of anaesthesia grading(ASA): I, II, III, prostatic volume of 30-80 cc Surgical duration 60-90 mins

Exclusion criteria

Exclusion criteria: refusal to enrol in study h/o allergy to local anaesthetic psychiatric or neurologic illness (Alzheimer’s, Schizophrenia, etc.) deformity of vertebral column coagulation disorder

Design outcomes

Primary

Measure	Time frame
Comparison of hemodynamic parameters (pulse , Systolic BP, Diastolic BP, Mean Arterial Pressure)in between the two groups Timepoint: Time of complete drug administration in the Subarachnoid space will be taken as T0. Hemodynamic parameters like pulse, systolic blood pressure(SBP),diastolic blood pressure(DBP),mean arterial pressure will recorded every 3 min for the first 15 min, every 5 min for next 15 min, and then every 10 min until the end of surgery. Clinically relevant hypotension (decrease in MAP 20% of baseline) will be treated with a bolus of 6 mg Mephentermine.	—

Measure

Time frame

Comparison of hemodynamic parameters (pulse , Systolic BP, Diastolic BP, Mean Arterial Pressure)in between the two groups Timepoint: Time of complete drug administration in the Subarachnoid space will be taken as T0. Hemodynamic parameters like pulse, systolic blood pressure(SBP),diastolic blood pressure(DBP),mean arterial pressure will recorded every 3 min for the first 15 min, every 5 min for next 15 min, and then every 10 min until the end of surgery. Clinically relevant hypotension (decrease in MAP 20% of baseline) will be treated with a bolus of 6 mg Mephentermine.

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Secondary

Measure	Time frame
Difference in time to achieve level of sensory block in both the groups Difference in time to achieve level of motor block in both the groups Duration of analgesia Look for any complications Timepoint: The level of sensory blockade will be measured bilaterally using pin prick test at 3, 5, 10, 30, 45, 60, and 120 min after injection. The level of motor blockade will be assessed using the bromage scale. The assessment of the motor blockade will be done at 10 and 120 min after injection.	—

Measure

Time frame

Difference in time to achieve level of sensory block in both the groups Difference in time to achieve level of motor block in both the groups Duration of analgesia Look for any complications Timepoint: The level of sensory blockade will be measured bilaterally using pin prick test at 3, 5, 10, 30, 45, 60, and 120 min after injection. The level of motor blockade will be assessed using the bromage scale. The assessment of the motor blockade will be done at 10 and 120 min after injection.

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Countries

India

Contacts

Public ContactDr BHAVESH DALWADI

GMERS Medical College,Gotri,Vadodara

bhaveshkdalwadi@gmail.com9825042148

Outcome results

None listed

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