CTRI Number |
CTRI/2023/02/050011 [Registered on: 23/02/2023] Trial Registered Prospectively |
Last Modified On: |
21/02/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical trial to study the comparison of two different nerve blocks for pain relief in patients undergoing upper abdominal surgery |
Scientific Title of Study
|
Comparison of ultrasound guided External Oblique Intercostal Plane Block and Subcostal Transversus Abdominis Plane Block in patients undergoing upper abdominal surgery: A randomized clinical study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Chandni Sinha |
Designation |
Additional Professor |
Affiliation |
All India Institute of Medical Sciences,Patna |
Address |
Dept of Anesthesia.
Room no. 2 B5A New OT Complex IPD building AIIMS Patna, Phulwarisharif Patna
Patna BIHAR 801507 India |
Phone |
7250333148 |
Fax |
|
Email |
chandni.doc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Chandni Sinha |
Designation |
Additional Professor |
Affiliation |
All India Institute of Medical Sciences,Patna |
Address |
Dept of Anesthesia.
Room no. 2 B5A New OT Complex IPD building AIIMS Patna, Phulwarisharif Patna
Patna BIHAR 801507 India |
Phone |
7250333148 |
Fax |
|
Email |
chandni.doc@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Chandni Sinha |
Designation |
Additional Professor |
Affiliation |
All India Institute of Medical Sciences,Patna |
Address |
Dept of Anesthesia.
Room no. 2 B5A New OT Complex IPD building AIIMS Patna, Phulwarisharif Patna
Patna BIHAR 801507 India |
Phone |
7250333148 |
Fax |
|
Email |
chandni.doc@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute Of Medical Sciences, Phulwarisharif , Patna-801507
Bihar |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences, Patna |
Address |
All India Institute of Medical Sciences, Patna Phulwarisharif Patna-801507 |
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 Chandni Sinha |
All India Institute of Medical Sciences, Patna |
Dept of Anesthesia.
Room no. 2, B5A, New OT Complex, IPD building, AIIMS Patna
Phulwarisharif
Patna BIHAR |
7250333148
chandni.doc@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 |
Comparator Agent |
Ultrasound guided subcostal transversus abdominis plane block |
The US probe will be placed immediately below the costal margin in an oblique plane close to midline to identify the rectus abdominis muscle. The transversus abdominis muscle will be identified lying posterior to the rectus muscle. An 8cm 22-gauge block needle will be inserted using an in- plane approach. Transversus abdominis plane will be accessed by placing the needle adjacent to costal margin but medial to linea semilunaris. The needle will be advanced slowly in-plane to promote hydrodissection. A volume of 25ml 0.2% Ropivacaine will be injected.
|
Intervention |
Ultrasounded guided external oblique intercostal plane block |
After induction of general anaesthesia patients in group E will receive ultrasound guided External Oblique Intercostal Plane block. With patient in supine position high frequency linear transducer will be placed in the sagittal plane between midclavicular and anterior axillary line at the level of 6th rib. After optimization of image, 8cm 22-gauge block needle will be inserted from superomedial to inferolateral direction through the external oblique muscle. 25ml of 0.2% Ropivacaine will be deposited between the external oblique and intercostal muscle at the caudal end of the 6th rib.Time of block performance(TBP) will be observed. The TBP will be accepted as the time from the placement of the US probe on the skin to the administration of the injection and will be recorded by the anesthesia technician. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
ASA I –II patients scheduled to undergo elective supra-umbilical surgeries with unilateral
incision under GA
|
|
ExclusionCriteria |
Details |
1. BMI< 20
2. Allergy to local anesthetics
3. Infection at the site of injection
4. Chronic pain syndromes
5. Patients on chronic analgesic therapy
6. Chronic liver disease, chronic renal disease, and cognitive impairment
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Time to first rescue analgesic administration |
Time to first rescue analgesic administration |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time of block performance (TBP)
Intraoperative fentanyl consumption
Amount of postoperative Fentanyl consumption in first 24 hours
Postoperative pain score evaluated by NRS at 0,1,2,4, 6, 12 and 24 hrs.
Complications
|
0,1,2,4, 6, 12 and 24 hrs. |
|
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)
|
01/03/2023 |
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 - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-12-2023 and end date provided 31-12-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
|
This is a clinical trial to compare the analgesic efficacy of ultrasound guided External Oblique Intercostal Plane Block better and Subcostal Transversus Abdominis Plane Block in patients undergoing upper abdominal surgery. Group E will receive US-guided External Oblique Intercostal Plane block using 25ml of 0.2% Ropivacaine along with GA and Group T will receive US-guided Subcostal TAP block using 25ml of 0.2% Ropivacaine along with GA. Total intraoperative fentanyl consumption will be
noted in both groups. Time of block performance(TBP) will be observed in each group. Pain perception will be measured in the PACU at
rest by using NRS (0–10) at 0,1,2,4,6,12, and 24 hour, total opioid consumption will be recorded and complications if any will be noted |