| CTRI Number |
CTRI/2024/12/078240 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| 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
|
Comparison between both sided rectointercostal fascial plane block and rectus sheath plane block for pain management in upper abdominal surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided bilateral recto-intercostal
fascial plane block with rectus sheath plane block in adult patients undergoing abdominal surgery through upper midline incision: a randomized control 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 |
Guruprasad Sahoo |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anaesthesiology , OT Complex , 5th floor , AIIMS
Patna , Phulwarisharif , Patna , Bihar , India
Patna
BIHAR
801507
India
Patna
BIHAR
801507
India |
| Phone |
8457815326 |
| Fax |
|
| Email |
guruprasad.sahu303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anaesthesiology , OT Complex , 5th floor , AIIMS
Patna , Phulwarisharif , Patna , Bihar , India
Patna
BIHAR
801507
India
Department of Anaesthesiology , OT Complex , 5th floor , AIIMS
Patna , Phulwarisharif , Patna , Bihar , India
Patna
BIHAR
801507
India
Patna
BIHAR
801507
India |
| Phone |
7765937919 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anaesthesiology , OT Complex , 5th floor , AIIMS
Patna , Phulwarisharif , Patna , Bihar , India
Patna
BIHAR
801507
India
Department of Anaesthesiology , OT Complex , 5th floor , AIIMS
Patna , Phulwarisharif , Patna , Bihar , India
Patna
BIHAR
801507
India
Patna
BIHAR
801507
India |
| Phone |
7765937919 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , All India Institute of Medical Sciences , Patna , Phulwarisharif |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences , Patna |
| Address |
Department of Anaesthesiology , OT Complex , 5th floor , AIIMS
Patna, Phulwarisharif , Patna , Bihar , Pin : 801507 , India |
| 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 Guruprasad Sahoo |
All India Institute of Medical Sciences , Patna |
Department of Anaesthesiology , OT Complex , 5th floor , AIIMS
Patna , Phulwarisharif , Patna , Bihar , India
Patna
BIHAR
801507
India
Patna
BIHAR |
8457815326
guruprasad.sahu303@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: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rectointercostal fascial plane block |
Patient will receive Rectointercostal fascial plane block bilaterally after General Anaesthesia.The block will be performed at the 6th and 7th costal cartilage between the posterior rectus sheath and cartilage with 20 ml of Inj 0.25% Bupivacaine |
| Comparator Agent |
Rectus Sheath Plane block |
Patient will receive Rectus sheath plane block bilaterally after General Anaesthesia.Block will be performed in the posterior layer of Rectus sheath with 20ml Inj 0.25% Bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA (American Society of Anaesthesiologists) physical status classification I or II.
2.Patients scheduled to undergo elective upper abdominal surgery through midline incision
|
|
| ExclusionCriteria |
| Details |
BMI more than 35
History of alcohol abuse, drug abuse and psychiatric illness
History of chronic pain
Inability to comprehend pain
|
|
|
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 |
To compare Post-operative fentanyl consumptions in Rectointercostal fascial plane block versus Rectus sheath plane block
|
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative fentanyl consumption in Rectointercostal block versus Rectus sheath block
Time for first rescue analgesia in Rectointercostal block versus Rectus sheath block
Postoperative Pain Score (NRS) at 30 min, 2hour, 4 hour, 8 hour, 12 hour, 24 hour in Rectointercostal block versus Rectus sheath block
Adverse effects -Hematoma, LAST, Puncture of peritoneum/bowel, infection in Rectointercostal block and Rectus sheath block
|
30 min, 2hour, 4 hour, 8 hour, 12 hour, 24 hour |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/01/2025 |
| 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="2"
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
|
Comparison of analgesic efficacy of ultrasound guided bilateral recto-intercostal fascial plane block with Rectus Sheath plane block in adult patients undergoing abdominal surgery through upper midline incision
There is no any study to compare the efficacy of Recto intercostal fascial plane block with Rectus sheath plane block for Abdominal Surgeries with upper midline incision.Our study is focused on which block is more effective |