| CTRI Number |
CTRI/2025/01/079325 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Study the efficacy of pre-emptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and requirement of analgesic consumption.
|
|
Scientific Title of Study
|
Study the efficacy of pre-emptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samya Shrivastava |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8458986856 |
| Fax |
|
| Email |
samyashrivastava6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and
Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
Samya Shrivastava |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samya Shrivastava |
Dr. D.Y. Patil Hospital and Research Centre |
Department of
Anaesthesia, 5th Floor,
Hi-tech building, Dr.
D.Y.Patil Medical
College, Hospital and
Research Centre, Sant
Tukaram Nagar, Pimpri,
Pune 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
08458986856
samyashrivastava6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab neurobione Forte (placebo) |
Placebo (tab neurobion forte), 1 hour prior to PCNL surgery.
 |
| Intervention |
Tab. Pregabalin |
Preemptive Pregabalin 100 mg 1 hour prior to PCNL surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption. |
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. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
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 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a Prospective, randomized, double blind comparative study to study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption.
60 patients planned for surgery under spinal anesthesia will be divided into 2 groups of 30 patients each: Group G (Pregabalin) and Group P (Placebo) - each given 1 hour prior to PCNL surgery.
Other objectives include
To assess the VAS score Post operatively To assess opioid consumption in first 24 hours
To evaluate the time to first rescue analgesia To assess the score of catheter related discomfort post operatively
To asssess haemodynamic Parameters intra operatively and post operatively .
To assess Ramsay sedation score intra operatively and post operatively
To observe any side effects. |