| CTRI Number |
CTRI/2020/08/027432 [Registered on: 27/08/2020] Trial Registered Prospectively |
| Last Modified On: |
24/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing ultrasound guided Erector Spinae block and local skin infiltration for postoperative analgesia in patients of lumbar spine surgery. |
|
Scientific Title of Study
|
Comparison of ultrasound guided Erector Spinae plane block and local skin infiltration for postoperative analgesia in adult patients undergoing lumbar spine surgery under general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohandeep kaur |
| Designation |
Professor and Head of Department |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia hospital New Delhi |
| Address |
Hod office, Department of Anaesthesia ,ABVIMS and Dr RML hospital, baba kharak Singh marg,New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868952253 |
| Fax |
|
| Email |
mdkaur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohandeep kaur |
| Designation |
Professor and Head of Department |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia hospital New Delhi |
| Address |
Hod office, Department of Anaesthesia ,ABVIMS and Dr RML hospital, baba kharak Singh marg,New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868952253 |
| Fax |
|
| Email |
mdkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Mittal |
| Designation |
Post graduate resident |
| Affiliation |
ABVIMS and Dr RML hospital New Delhi |
| Address |
Department of Anaesthesia, ABVIMS and Dr RML hospital, baba kharak Singh marg, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9888892568 |
| Fax |
|
| Email |
drmansi325@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of medical sciences and Dr Ram Manohar Lohia hospital , Baba Kharak sinh marg , near Bangla sahib gurudwara , Connaught Place , New Delhi |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML hospital |
| Address |
Baba kharak Singh marg, near Bangla sahib gurudwara, New Delhi |
| 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 |
| Mansi Mittal |
Atal Bihari Vajpayee institute of medical sciences ,Dr Ram Manohar Lohia Hospital |
Department of Anaesthesia
New Delhi
DELHI |
9888892568
drmansi325@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, PGIMER, Dr RML hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M990||Segmental and somatic dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
Ultrasound guided erector spinae plane block with 20ml of 0.25% bupivacaine at the level of T10 on both sides(10 ml on each side) immediately after surgery before extubation. |
| Comparator Agent |
Local skin infiltration |
Local skin infiltration with 20 ml of 0.25% bupivacaine at the incision site immediately after surgery before extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Age between 18 to 80 yrs
2) ASA 1&2 |
|
| ExclusionCriteria |
| Details |
1) Preexisting coagulation disorder
2) Infection at site of injection
3) Allergy to Bupivacaine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia from time of administration of block to time of first rescue analgesia |
VAS score at 15 min, 30 min, 1hr, 1.5hr, 2hr, 4hr and 6 hr interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Haemodynamic parameters- Heart rate,blood pressure, mean arterial pressure and saturation
2)Adverse effects of drugs- Hypotension, nausea, vomiting |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is randomised comparative study comparing ultrasound guided erector spinae plane block and local skin infiltration for postoperative analgesia in adult patients undergoing lumbar spine surgery under general anaesthesia with a sample size of 60(30 in each group). Study will be conducted at ABVIMS Dr RML hospital New Delhi, India. Primary outcome will be comparison of duration of analgesia using VAS score. |