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CTRI Number  CTRI/2025/07/090672 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different techniques for postoperative pain management in spine surgery 
Scientific Title of Study   Comparative Study of Wound Infiltration Versus Instillation Technique for Postoperative Analgesia Using 0.375 Percentage Ropivacaine in Patients undergoing Lumbar Laminectomy Surgery  
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 Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr SN medical collage, Jodhpur 
Address  Main OT Complex First floor Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur RAJASTHAN 342001
Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Manisha Paliwal 
Designation  Junior Resident 
Affiliation  Dr SN Medical Collage, Jodhpur 
Address  Main OT Complex First floor Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur RAJASTHAN 342001
Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09887660296  
Fax    
Email  manishapaliwal1998@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr SN medical collage, Jodhpur 
Address  Main OT Complex First floor Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur RAJASTHAN 342001
Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia MDM Hospital Dr S N Medical College Jodhpur RAJASTHAN 342001  
 
Primary Sponsor  
Name  M D M Hospital Dr S N Medical College Jodhpur  
Address  Shastri Nagar Jodhpur Rajasthan  
Type of Sponsor  Government 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 Geeta Singariya  MDM hospital, Dr S N Medical collage, Jodhpur  OT Complex First floor Department of Anaesthesia M D M Hospital Dr S N Medical College Shastri Nagar Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee   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 
Intervention  Infiltration   20 ml of 0.375% ropivacaine will be Injected into the paravertebral muscles, subcutaneous tissues, and along the wound edges, before wound closure, typically after achieving hemostasis 
Comparator Agent  Instillation  20 ml of 0.375% ropivacaine will be poured directly into the surgical wound after achieving hemostasis and before wound closure. Allow the solution to remain in contact with the wound tissues for approximately 60 seconds to ensure adequate absorption 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient of American Society of Anesthesiologists (ASA) physical status classification I and II, posted for elective single-level lumbar laminectomy under general anaesthesia  
 
ExclusionCriteria 
Details  Patient refusal known allergy or hypersensitivity to amide local anaesthetics local infection at the surgical site chronic opioid use coagulopathy or anticoagulant therapy severe hepatic or renal impairment history of chronic pain or psychiatric illness interfering with pain scoring any neurological deficits intraoperative dural tear 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the rescue analgesic consumption in wound infiltration versus wound instillation of 0.375% ropivacaine patients undergoing lumbar laminectomy surgery  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Pain scores (VAS)
Duration of analgesia
Adverse events
Patient satisfaction  		 24 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/07/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [geetamanojkamal@gmail.com].

  6. For how long will this data be available start date provided 09-07-2026 and end date provided 09-07-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomised comparative trial will be conducted in the Department of Anesthesiology in collaboration with the Department of Neurosurgery, Dr. S.N. Medical College and the associated group of hospitals in Jodhpur, Rajasthan, India. The study will be conducted after approval from the Institutional Ethics Committee and CTRI registration. A pre-anaesthetic check-up will be conducted for all patients; details related to clinical history, general physical examination, and all necessary investigations will be carried out. All patients will be informed about the numerical rating scale (NRS), a scale of 0-10 (0 = no pain and 10 = worst pain) [17] and will be assessed the day before surgery. All patients will be kept fasting overnight and will be pre-medicated with tablet lorazepam 0.05 mg/kg and tablet ranitidine 150 mg orally the night before surgery. 

Upon arrival in the operating room, all standard ASA monitors will be applied, and baseline parameters of non-invasive blood pressure (NIBP), heart rate (HR), electrocardiogram (ECG), and peripheral oxygen saturation (SpO2) will be recorded and maintained throughout the perioperative period. Peripheral intravenous access will be obtained with an 18-G cannula, and lactated Ringer`s solution will be started. General anaesthesia will be given as per protocol. 

At the end of the surgical procedure and when hemostasis was achieved, Group I (Wound Infiltration) will receive 20 ml of 0.375% ropivacaine infiltrated into the muscle layers, subfascial plane, and subcutaneous tissue around the surgical site using a 20 ml syringe before skin closure and Group S (Wound Instillation) will receive 20 ml of 0.375% ropivacaine poured directly into the surgical wound cavity after dural closure and just before skin closure. The wound will be closed in layers without mopping or suctioning. The drug solution will allow it to remain in the wound for a contact time of 60 seconds. Thereafter, the wound will be closed in layers, and no mopping or suctioning will be done. At the end of surgery, patients will be turned supine and residual neuromuscular blockade will be reversed and the trachea will be extubated when the patient is fully awake and breathing adequately, an assessment for pain will be done and recorded and will be shifted to the post anaesthesia care unit (PACU). 
 
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