| CTRI Number |
CTRI/2023/03/050416 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Different Regional Anaesthetic Techniques With Standard IV Analgesic Technique For Post-Operative Pain Management In Patients Undergoing Laproscopic Cholecystectomy. |
|
Scientific Title of Study
|
A Randomized Controlled Prospective Clinical Study Of Ultrasound Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block For Post Operative Analgesia In Patients Undergoing Laproscopic Cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHINAV NANDA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesiology and Critical Care, Subharti Medical College, Subharti University, Subhartipuram, Meerut, 250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9780848998 |
| Fax |
|
| Email |
drabhinavnanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHAWANA RASTOGI |
| Designation |
PROFESSOR & HEAD OF THE DEPARTMENT |
| Affiliation |
Subharti Medical College |
| Address |
Deptt. of Anaesthesiology & Critical Care, Subharti Medical College, Subharti University, Subhartipuram, Meerut, 250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8449114984 |
| Fax |
|
| Email |
28bhawana75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ABHINAV NANDA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Subharti Medical College |
| Address |
Deptt. of Anaesthesiology and Critcal Care, Subharti Medical College, Subharti University, Subhartipuram, Meerut, 250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9780848998 |
| Fax |
|
| Email |
drabhinavnanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUBHARTI MEDICAL COLLEGE, SUBHARTI UNIVERSITY, SUBHARTIPURAM, MEERUT 250005 |
|
|
Primary Sponsor
|
| Name |
ABHINAV NANDA |
| Address |
Shyam Krishna Hostel, Subharti Medical College, Subharti University, Subhartipuram, Meerut, 250005 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SUBHARTI MEDICAL COLLEGE |
Subharti University, Subhartipuram, Meerut, 250005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Abhinav Nanda |
Subharti Medical College and Hospital |
Department of Anaesthesiology and Critical Care, Subharti Medical College, Subharti University, Subhartipuram, 250005
Meerut
UTTAR PRADESH |
9780848998
drabhinavnanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE (MEDICAL), SWAMI VIVEKANAND SUBHARTI UNIVERSITY |
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 |
ERECTOR SPINAE PLANE BLOCK |
Erector Spinae Plane (ESP) Block Is An Interfascial Plane Block Where A Local Anaesthetic Is Injected In Plane In The Erector Spinae Muscle. This block will be given before induction of general anaesthesia. |
| Comparator Agent |
Inj. Butorphanol |
IV Analgesic
Dose 1mg |
| Intervention |
TRANSVERSUS ABDOMINIS PLANE BLOCK |
The Needle Will Be Introduced In Plane Of The Ultrasound Probe Directly Under The Probe And Advanced Until It Reaches The Plane Between The Internal Oblique And Transversus Abdominis Muscles And Drug Will Be Injected.
This block will be given before induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I-II |
|
| ExclusionCriteria |
| Details |
1. Allergy to the study drug
2. Bleeding disorders
3. Inability to visualize the plane on USG
4. Patient using chronic analgesic medication
5. Psychiatric disorder
6. Contraindication to regional anaesthesia
7. Patient refusal
8. Cardiorespiratory disorder (e.g bronchial asthma,bradyarrythmias,heart
9. Block, CAD)
10. Hepatic , renal and neurological disease
11. Emergency operation.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare pain intensity after erector spinae plane block and transversus abdominis plane block.
Assessment of pain was done using NRS score.
2. To evaluate and compare the time of first analgesic demand (hours) and the total amount of rescue analgesic consumption during the first 24 hours of postoperative period.
|
Assessment was done using NRS both at rest and on movement immediately and then at 15 min, 30 min, 45 min, 60 min, second hour, fourth hour, sixth hour, eighth hour, tenth hour,12th hour, and 24th hours postoperative.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare overall patient satisfaction score using likert verbal rating score among the three groups.
|
A 7-point Likert verbal rating scale will be used to assess patient satisfaction immediately and then at 15 min, 30 min, 45 min, 60 min, second hour, fourth hour, sixth hour, eighth hour, tenth hour,12th hour, and 24th hours postoperative
|
2. To compare hemodynamic changes among the three groups.
|
Heart rate and mean arterial pressure will be monitored immediately post op and then at 15 min, 30 min, 45 min, 60 min, second hour, fourth hour, sixth hour, eighth hour, tenth hour,12th hour, and 24th hours postoperative. |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
Final Enrollment numbers achieved (Total)= "111"
Final Enrollment numbers achieved (India)="111" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2023 |
| Date of Study Completion (India) |
20/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drabhinavnanda@gmail.com].
- For how long will this data be available start date provided 15-03-2023 and end date provided 15-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized,
controlled, parallel group, single centre trial comparing the analgesic
efficacy of ultrasound guided erector spinae plane block and transversus abdominis
plane block for post-operative analgesia in patients undergoing laproscopic
cholecystectomy. The study will be conducted over 18 months in 111
patients in Subharti Medical College,Meerut, UP India. The primary outcome
measures will be to evaluate and compare pain intensity after erector spinae
plane block and transversus abdominis plane block and compare it with standard IV analgesic technique
and to evaluate and compare the time of first analgesic demand
(hours) and the total amount of rescue analgesic consumption during
the first 24 hours of postoperative period. The secondary outcomes will
be to compare overall patient satisfaction score and to compare hemodynamic changes
among the three groups. |