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CTRI Number  CTRI/2025/10/096276 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 19/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two epidural adjuvants for endoscopic lumbar spine surgeries. 
Scientific Title of Study   Evaluation of epidural ropivacaine with fentanyl and ropivacaine with dexmedetomidine for endoscopic lumbar spine 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 Tanmay Saxena 
Designation  First year anaesthesia PG 
Affiliation  Care CHL Hospital, Indore 
Address  Department of Anaesthesia, Care CHL Hospital, Lig Square, AB Road, Indore, Madhya Pradesh – 452008.

Indore
MADHYA PRADESH
452008
India 
Phone  9340055214  
Fax    
Email  tanmay.saxena410@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Meenu Chadha 
Designation  Head of department, Department of Anaesthesia 
Affiliation  Care CHL Hospital, Indore 
Address  Department of Anaesthesia, Care CHL Hospital, Lig Square, AB Road, Indore, Madhya Pradesh – 452008.

Indore
MADHYA PRADESH
452008
India 
Phone  9977161035  
Fax    
Email  chadha.meenu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Meenu Chadha 
Designation  Head of department, Dept. of Anaesthesia 
Affiliation  Care CHL Hospital, Indore 
Address  Department of Anaesthesia, Care CHL Hospital, Lig Square, AB Road, Indore, Madhya Pradesh – 452008.

Indore
MADHYA PRADESH
452008
India 
Phone  9977161035  
Fax    
Email  chadha.meenu@gmail.com  
 
Source of Monetary or Material Support  
Care CHL hospital, Indore, Madhya Pradesh 
 
Primary Sponsor  
Name  not applicable 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Tanmay Saxena  Care CHL Hospital  Department of Anaesthesia, Care CHL Hospital, Lig Square, AB Road, Indore, Madhya Pradesh – 452008.
Indore
MADHYA PRADESH 
9340055214

tanmay.saxena410@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Integrity Ethics Committee, CARE CHL Hospitals, Indore  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  Ropivacaine + Dexmedetomidine   10 ml of 0.2% Ropivacaine with Dexmedetomidine at 0.4 mcg per ml of Ropivacaine administered in the epidural space at the time of induction of anaesthesia. 
Comparator Agent  Ropivacaine + Fentanyl  10 ml of 0.2% Ropivacaine with Fentanyl at 2 mcg per ml of Ropivacaine administered in the epidural space at the time of induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i. Patients aged 18–65 years.
ii. ASA physical status I–II.
iii. Scheduled for elective endoscopic spine surgeries.
iv. Provided informed consent. 
 
ExclusionCriteria 
Details  1. Known allergy to study drugs.
2. Coagulopathy or bleeding disorders.
3. Infection at the injection site.
4. Neurological or psychiatric illness.
5. Severe cardiorespiratory or renal disease. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intra Operative Pain  0( at time of induction), 5 minutes, 10 minutes, 15
minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes,
150 minutes, 180 minutes, 240 minutes, 300 minutes, 360 minutes, and 12 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Onset & duration of analgesia
2. Hemodynamic stability
3. Intraoperative pain
4. Sedation
5. Motor block assessment
6. Sensory block level
7. Degree of intraoperative cooperation
8. Need for rescue analgesia 
0 (at time of induction), 5 minutes, 10 minutes, 15
minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes,
150 minutes, 180 minutes, 240 minutes, 300 minutes, 360 minutes, & 12 hours. 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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 1 
Date of First Enrollment (India)   30/10/2025 
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="6"
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  

This proposed clinical study is a prospective, randomized, comparative trial designed to evaluate the efficacy and safety of two epidural drug combinations like Ropivacaine with Fentanyl versus Ropivacaine with Dexmedetomidine—in patients undergoing endoscopic lumbar spine surgeries. In the lumbar spine surgeries, particularly through the endoscopic approach, are known for advantages like minimal invasiveness, reduced tissue damage, and faster recovery. However, pain management remains a significant challenge, particularly in the early postoperative period. Effective analgesia not only reduces patient discomfort but also facilitates early mobilization, reduces hospital stay, and improves overall surgical outcomes.

Ropivacaine is a long-acting amide local anesthetic, is preferred due to its lower cardiotoxicity and motor blockade profile compared to bupivacaine. However, its effect can be further enhanced with the use of adjuvant drugs. Fentanyl is a synthetic opioid, is commonly used due to its rapid onset and synergistic analgesic effect when combined with local anesthetics. However, it is associated with opioid-related side effects like nausea, pruritus, urinary retention, and respiratory depression. Dexmedetomidine is an alpha-2-adrenergic receptor agonist, has gained attention as an adjuvant because of its sedative, analgesic, and sympatholytic properties without causing significant respiratory depression. It may also prolong the duration of sensory and motor block when used epidurally.

The objective of this study is to compare both combinations based on several critical parameters, including Intraoperative and postoperative analgesic efficacy, Time to onset and duration of sensory and motor blockade, Hemodynamic stability during and after surgery, Quality of sedation and patient comfort levels, Postoperative pain scores using standardized scales, Time to first rescue analgesia and total analgesic consumption and, incidence of adverse effects like hypotension, bradycardia, nausea, vomiting, and pruritus.

In this randomized study we will enroll patients who meet the inclusion criteria and are undergoing elective endoscopic lumbar spine procedures under epidural anesthesia. Patients will be randomly assigned to either group, and standardized protocols for anesthesia and postoperative care will be followed. The findings are expected to offer evidence-based guidance for selecting the most effective adjuvant in epidural anesthesia for spine surgeries. The ultimate goal is to Improve perioperative pain control, Enhance patient safety and satisfaction, Minimize opioid-related side effects and, Support early ambulation and faster recovery

This research may contribute to refining anesthetic protocols for minimally invasive spine procedures and establishing best practices for pain management in the neurosurgical and orthopedic fields.

 
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