To Study the efficacy of pre-emptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and requirement of analgesic consumption.

Study the efficacy of pre-emptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption. - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079325

Enrollment

Registered

2025-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Tab. Pregabalin: Preemptive Pregabalin 100 mg 1 hour prior to PCNL surgery. Control Intervention1: Tab neurobione Forte (placebo): Placebo (tab neurobion forte), 1 hour prior to PCNL s

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I or II fit patients. Patients aged between 18 and 60 years of age. Patients undergoing PCNL surgeries under spinal anesthesia. Hemodynamically stable patients with all routine investigations within normal limits and without any comorbidities. Written informed consent from the concerned patient.

Exclusion criteria

Exclusion criteria: Patients who are not willing to participate in the study. Patients with ASA grade III and above physical status. Patients who are aged less than 18 and more than 60 years of age. Patients who are posted for emergency procedures. Patients with known allergy to the study drugs. Patients who have psychiatric, coagulopathic, neurological, neuromuscular, or cardiovascular disease or impairment of hepatic or renal function. Patients with coagulopathies and contraindication to Spinal Anaesthesia.

Design outcomes

Primary

Measure	Time frame
To study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption.Timepoint: Patients will be assesed on the level of pain they experienced using the 10 point Visual Analog Scale (VAS), along with Vital signs and Ramsay Sedation Score - post operatively at the end of suregery, 30 minutes, 2 hours, 6 hours, 12 hours and 24 hours. Opioid consumption, need of rescue analgesics and any adverse effects will be noted. Patients will also be assessed on the for any instrumentation induced discomfort/ catheter related discomfort at 0,2,6, 12 and 24 hours.	—

Measure

Time frame

To study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption.Timepoint: Patients will be assesed on the level of pain they experienced using the 10 point Visual Analog Scale (VAS), along with Vital signs and Ramsay Sedation Score - post operatively at the end of suregery, 30 minutes, 2 hours, 6 hours, 12 hours and 24 hours. Opioid consumption, need of rescue analgesics and any adverse effects will be noted. Patients will also be assessed on the for any instrumentation induced discomfort/ catheter related discomfort at 0,2,6, 12 and 24 hours.

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Secondary

Measure	Time frame
To study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to evaluate the time to first rescue analgesia & to observe any side effects Timepoint: Patients will be assesed on the level of pain they experienced using the ten point Visual Analog Scale along with Vital signs & Ramsay Sedation Score intra operatively & post operatively The time to first rescue analgesia & any side effects will also be noted	—

Measure

Time frame

To study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to evaluate the time to first rescue analgesia & to observe any side effects Timepoint: Patients will be assesed on the level of pain they experienced using the ten point Visual Analog Scale along with Vital signs & Ramsay Sedation Score intra operatively & post operatively The time to first rescue analgesia & any side effects will also be noted

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Countries

India

Contacts

Public ContactDr Aparna Bagle

DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE

draparnabagle@gmail.com9834430811

Outcome results

None listed

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