| 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
|
|
|
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
|
|
|
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. |