| CTRI Number |
CTRI/2026/04/107562 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of Ultrasound-Guided Modified Thoracolumbar Interfascial Plane Block and Lumbar Erector Spinae Plane Block in Lumbar Spine Surgery: Impact on Pain Scores, Opioid Requirement, and Patient Satisfaction . |
|
Scientific Title of Study
|
To compare the efficacy of ultrasound guided modified thoracolumbar
Interfascial plane block and lumbar-erector spinae plane block in lumbar spine surgeries - A randomised comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angezna Dharma |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi medical college |
| Address |
Department of anaesthesia, Indira Gandhi medical college , lakkar bazar , Shimla , Himachal Pradesh . 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8219180783 |
| Fax |
|
| Email |
angeznadharma31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta mahajan |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi medical college |
| Address |
Department of anaesthesia, Indira Gandhi medical college , lakkar bazar , Shimla , Himachal Pradesh . 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418040187 |
| Fax |
|
| Email |
shwetamahajan437@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Angezna Dharma |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi medical college |
| Address |
Department of anaesthesia, Indira Gandhi medical college , lakkar bazar , Shimla , Himachal Pradesh . 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8219180783 |
| Fax |
|
| Email |
angeznadharma31@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Angezna dharma |
| Address |
Indira Gandhi medical college , lakkar bazar , Shimla , Himachal Pradesh 171001 |
| 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 Angezna dharma |
Indira Gandhi medical college |
Department of anaesthesia, second floor , B-block,Indira Gandhi medical college , lakkar bazar , Shimla , Himachal Pradesh , 171001
Shimla
HIMACHAL PRADESH |
8219180783
angeznadharma31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Indira Gandhi medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided lumber- erector spinae plane block in lumber spine surgeries |
Comparision between the efficacy of ultrasound guided erector spinae block and modified thoracolumber interfascial plane block in lumber spine surgeries. Patients will be divided into two groups with the help of the randomisation technique. Patients falling under Group A will undergo a mTLIP block bilaterally with a dose of 0.5% ropivacaine 15 mL and 100 mcg dexmedetomidine on each side after induction of patient under general anaesthesia at IGMC ,Shimla while patients belonging to Group B will receive Lumbar Erector Spinae Plane (L-ESP) block with of a mixture of 15 ml of 0.5% Ropivacaine and 100mcg dexmedetomidine on each side after induction with GA at IGMC, Shimla. After the completion of surgery the patient will be extubated and transferred to the post- anaesthesia care unit .At PACU ,the patient’s visual analog score (VAS) will be assesed . Time zero will be the pain status of the patient after shifting the patient to the Post anaesthesia care unit. Patient satisfaction score will be observed after a period of 48 hours and compared among the two groups. |
| Intervention |
Ultrasound guided modified thoracolumber interfascial plane block in lumber spine surgeries |
Comparision between the efficacy of ultrasound guided erector spinae block and modified thoracolumber interfascial plane block in lumber spine surgeries.
Patients will be divided into two groups with the help of the randomisation technique.
Patients falling under Group A will undergo a mTLIP block bilaterally with a dose of 0.5% ropivacaine 15 mL and 100 mcg dexmedetomidine on each side after induction of patient under general anaesthesia at IGMC ,Shimla while patients belonging to Group B will receive Lumbar Erector Spinae Plane (L-ESP) block with of a mixture of 15 ml of 0.5% Ropivacaine and 100mcg dexmedetomidine on each side after induction with GA at IGMC, Shimla. After the completion of surgery the patient will be extubated and transferred to the post- anaesthesia care unit .At PACU ,the patient’s visual analog score (VAS) will be assesed . Time zero will be the pain status of the patient after shifting the patient to the Post anaesthesia care unit. Patient satisfaction score will be observed after a period of 48 hours and compared among the two groups. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients age from 30 to 75 yrs.
ASA physical status I - lll
Elective lumbar spine surgeries |
|
| ExclusionCriteria |
| Details |
Patients with known allergy to local anaesthetics.
ASA lV.
Patient with previous lumbar spine surgeries.
Patients with a history of coagulopathy or on anticoagulant and anti-platelet drugs.
Polytraumatic patient with head injury or in shock.
Patients with infection at the site of block
Patients who refuse to participate in study.
Pregnant women.
Patients with chronic opioid use or psychiatric illness.
Patient receiving ketamine at the time of induction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative pain scores between ultrasound-guided lumber-Erector spine plane (ESP) block and modified thoracolumbar interfascial plane block (mTLIP) block in patients undergoing lumbar spine surgeries. |
Post operative at 0hour, 2 hr later , 4 hr later, 6 hr later, 12 hr later,18 hr later ,24 hr later, 48 hour late |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the duration of analgesic effects in the modified thoracolumbar interfascial plane block and Lumbar erector spinae plane block.
• To compare total rescue analgesia consumption in form of opioids like Tramadol 100mg as primary while NSAIDs like Diclofenac 75mg as secondary rescue analgesia in the first 24 hours.
• To assess patient satisfaction and block-related adverse effects in both groups.
|
0 hr , 2 hr, 4 hr, 6 hr, 12hr,18hr,24hr |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2026 |
| 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
|
We aim to study and compare the efficacy of ultrasound guided modified thoracolumbar interfascial plane block and lumbar erector spinae plane block in lumbar spine surgeries. Patients will be divided into two groups with the help of the randomisation technique. Patients falling under Group A will undergo a mTLIP block bilaterally with a dose of 0.5 percent ropivacaine 15 mL and 100 mcg dexmedetomidine on each side after induction of patient under general anaesthesia at IGMC,Shimla while patients belonging to Group B will receive Lumbar Erector Spinae Plane (L-ESP) block with of a mixture of 15 ml of 0.5 percent Ropivicaine and 100mcg dexmedetomidine on each side after induction with GA at IGMC, Shimla. After the completion of surgery the patient will be extubated and transferred to the post- anaesthesia care unit .At PACU ,the patient’s visual analog score (VAS) will be assesed . Time zero will be the pain status of the patient after shifting the patient to the Post anaesthesia care unit. Patient satisfaction score will be observed after a period of 48 hours and compared among the two groups. |