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CTRI Number  CTRI/2024/10/075846 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study for comparing two different doses of same drug in reducing pain medication requirement after surgery 
Scientific Title of Study   Comparison of effect of two different doses of oral Pregabalin in reducing postoperative analgesia in patients receiving neuraxial anaesthesia for surgical procedures - A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nanditha Padikkasu 
Designation  Postgraduate (MD Anaesthesiology) 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  B-21, B. C. Roy Ladies Hostel, SRM Nagar, SRM University, Potheri, Kattankulathur

Chennai
TAMIL NADU
603203
India 
Phone  9087284520  
Fax    
Email  nandithapadi96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Karthik 
Designation  Professor of Anaesthesiology 
Affiliation  SRM Institute of Science and Technology 
Address  Room No. 209, B-Block, 2nd floor, Department of Anaesthesiology, SRM Medical College Hospital and Research Centre, Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884360796  
Fax    
Email  karthikkrishnamoorthy1981@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Karthik 
Designation  Professor of Anaesthesiology 
Affiliation  SRM Institute of Science and Technology 
Address  Room No. 209, B-Block, 2nd floor, Department of Anaesthesiology, SRM Medical College Hospital and Research Centre, Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884360796  
Fax    
Email  karthikkrishnamoorthy1981@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Centre Room no.: 209, B-Block, 2nd Floor, Department of Anaesthesiology, SRM Medical College and Research Institute, Kattankulathur Kancheepuram TAMIL NADU, India 603203 
 
Primary Sponsor  
Name  SRM 
Address  Room No.: 209, B-Block, 2nd Floor, Department of Anaesthesiology, SRM Medical College and Research Centre, Kattankulathur  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nanditha Padikkasu  SRM Institute of Science and Technology  Room No.: 209, B-Block, 2nd Floor, Department of Anaesthesiology, SRM Medical College Hospital and Research Centre, Kattankulathur
Kancheepuram
TAMIL NADU 		 9087284520

nandithapadi96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Institutional Ethics Committee-Students   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neuraxial Anaesthesia  Conventional spinal anesthesia blockade given for the patients with Inj. Hyperbaric Bupivacaine 0.5% 0.3mg/kg. Need for analgesia is assessed at 0 hours, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours.  
Intervention  Pregabalin given preoperatively before patients receive spinal anesthesia blockade  One tablet of T.Pregabalin 150mg given per orally 1 hour preoperatively before patients receive spinal anesthesia blockade with Inj. Hyperbaric Bupivacaine 0.5% 0.3mg/kg. Need for analgesia is assessed at 0 hours, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours. 
Intervention  Pregabalin given preoperatively before patients receive spinal anesthesia blockade  One tablet of T.Pregabalin 300mg given per orally 1 hour preoperatively before patients receive spinal anesthesia blockade with Inj. Hyperbaric Bupivacaine 0.5% 0.3mg/kg. Need for analgesia is assessed at 0 hours, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients scheduled to undergo elective surgeries under neuraxial anaesthesia
2. ASA I and ASA II patients
3. Patients aged 18-65 years
4. Patients with BMI less than 24.9 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Spinal deformities
3. Raised ICP
4. Infection at site of procedure
5. Coagulation disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of postoperative analgesia between the 3 groups using Visual Analogue Scale  1hr, 3hr, 6hr, 12hr, 24hr  
 
Secondary Outcome  
Outcome  TimePoints 
To assess level of sedation using Ramsay Sedation Scale both preoperatively and postoperatively  1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 4.5hr, 5hr, 5.5hr, 6hr 
The number of rescue analgesic doses required in the first 24 hours  1hr, 6hr, 12hr, 24hr 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   05/11/2024 
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="1"
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   A total of 90 patients belonging to the age group of 18-65 years, assessed under ASA I and ASA II, scheduled for elective surgeries under spinal anesthesia blockade will be prospectively studied. In this double-blinded randomised controlled trial, a total of 90 participants will be allocated into three groups- Group A(Conventional Spinal Anaesthesia), Group B(150mg T.Pregabalin preoperatively) and Group C(300mg T.Pregabalin preoperatively). Patients will receive either their allocated drug or a placebo in the conventional group 1 hour before surgery. Their level of sedation will be assessed after the hour using Ramsay Sedation Scale before shifting the patients to the OT. All patients will receive 0.5% hyperbaric bupivacaine 0.3mg/kg intrathecally at L3-L4 space with 25G Quincke needle under aseptic precautions. All patients will be assessed for their pain using the Visual Analogue Scale postoperatively for 24 hours. Data collection will be done by observation and measurement of various parameters. 
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