| CTRI Number |
CTRI/2024/01/062100 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare analgesic impact of injecting local anaesthetic at single spine level with two spine level in patients undergoing spine surgeries. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of single level vs bi-level ultrasound guided retrolaminar block in patients undergoing throracolumbar spine surgery: 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. Manjunath N |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Room No:13,OPD Ground floor Department Of Anaesthesiology
AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9845630772 |
| Fax |
|
| Email |
mithunmanjunath107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amarjeet Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Room no:505,IPD 5th floor Department Of Anaesthesiology
AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9570890646 |
| Fax |
|
| Email |
amarjeetdmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manjunath N |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Room no:13,OPD Ground floor Department Of Anaesthesiology
AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9845630772 |
| Fax |
|
| Email |
mithunmanjunath107@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology
5th Floor IPD
AIIMS Patna |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department Of Anaesthesiology
IPD 5th Floor |
| Type of Sponsor |
Government medical college |
|
|
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 Manjunath N |
AIIMS Patna |
Department Of Anaesthesiology
5th Floor IPD OT Complex
AIIMS Patna 801507
Patna
BIHAR |
9845630772
mithunmanjunath107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS PATNA |
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 |
Bilevel retrolaminar block |
Two level retrolaminar block bilaterally (upper level: is one level above the uppermost operating vertebrae and lower level is one level below the lowermost operating vertebra). 10 ml 0.2% ropivacaine was injected bilaterally at both level (total volume 40 ml).
|
| Comparator Agent |
Single level retrolaminar block |
Single level retrolaminar block bilaterally at level of target vertebra situated in middle of the skin incision. 20 ml 0.2% ropivacaine will be injected bilaterally (total volume 40ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 Patients
Undergoing thoracic and lumbar spine surgeries less than or equal to 5 segments |
|
| ExclusionCriteria |
| Details |
ASA III or more
Allergy to the drugs
Coagulopathy
Infection at puncture site
Mental disorder, Communication failure, unable to discriminate cutaneous pin prick.
Chronic use of analgesics, inability to operate PCA pump
Preexisting spinal cord disease prior lumbar spine surgery
BMI more than or equal to 30
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total postoperative fentanyl consumption in 24 hours |
Within 24 hours of postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of pain during postoperative period measured through NRS scale |
1,2, 4, 6, 12, 24 hours |
Additional intraoperative fentanyl consumption
|
From the administration of block to end of the surgery |
Time to first rescue analgesia administration
|
From the administration of the block to the first use of analgesic |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
12/02/2024 |
| 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
|
Spine surgeries cause severe post operative pain.perioperative regional techniques have become essential part of pain management. A retrolaminar block has been found to be effective in various surgeries like lumbar surgeries,nephrectomy,thoracotomy,breast surgeries, and other retroperitoneal surgeries.However the optimal site of blocking has not yet been proven.Our study aims to determine the ideal blocking technique for patients undegoing thoracolumbar spine surgeries. |