| CTRI Number |
CTRI/2024/10/075246 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Rectointercostal nerve block both side of upper abdomen in adult patients for pain management |
|
Scientific Title of Study
|
Analgesic efficacy of ultrasound guided bilateral recto-intercostal fascial plane block in adult patients undergoing upper midline incision abdominal surgery: A randomised 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 |
Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room No-505,B block OT complex,All India Institute of Medical Sciences,Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room No-505,B block OT complex,All India Institute of Medical Sciences,Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room No-505,B block OT complex,All India Institute of Medical Sciences,Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Patna.
Phulwarisharif.801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department of anaesthesiology, B block, OT complex,AIIMS Patna |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Poonam Kumar |
Room No-505,B block OT complex,All India Institute of Medical Sciences,Patna |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poonam Kumari |
AIIMS Patna |
Department of anaesthesiology, B block,OT complex, Aiims patna
Patna
BIHAR |
9473199126
drpoonam1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC 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 |
Group I : Bilateral recto intercostal fascial plane block |
Group I: will receive a bilateral recto intercostal fascial plane block after general anesthesia with IV PCA analgesia.
bupivacaine 0.25% 15 ml both side. Total volume of drug 30 ml. Total duration 24 hours |
| Comparator Agent |
Group II: General anaesthesia |
Group II will receive only general anesthesia with IV PCA. Total duration 24 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I/II
2.Age (Either Sex) – 18 to 70 years
3.Scheduled for upper midline incision abdominal surgery
|
|
| ExclusionCriteria |
| Details |
1.Mental disorder
2.Communication failure
3.Inability to understand the functionality of patient-controlled analgesia pump
|
|
|
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 measure Post-operative morphine consumptions in 24 hours. |
To measure Post-operative morphine consumptions in 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Intraoperative fentanyl consumption
2) Time of first rescue analgesia
3) Postoperative Pain Score (NRS) at 30 min, 2hour, 4 hour, 8 hour, 12 hour, 24 hour.
4) Adverse effect
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Recent regional anaesthestic techniques are: erector spinae , retrolaminar block 3Tulgar et al., in a cadaveric study, described a novel regional block named recto-intercostal facial plane block (RIFPB), in which methylene blue dye was injected bilaterally in a plane between the rectus abdominis muscle and 6th or 7th costal cartilage at a site inferolateral to the xiphoid process. According to them, the injectate dye spreads longitudinally to the anterior cutaneous branches of the T6–T9 nerves and laterally to the entire lower thorax up to the mid-axillary line.4 We aim to evaluate the analgesic effect of ultrasound-guided recto-intercostal fascial plane block in reducing postoperative (24-hour) opioid consumption in patients undergoing upper abdominal surgery.§ Primary Objective – To measure Post-operative morphine consumptions in 24 hours. § Secondary objective: To evaluate - 1) Intraoperative fentanyl consumption 2) Time of first rescue analgesia 3) Postoperative Pain Score (NRS) at 30 min, 2hour, 4 hour, 8 hour, 12 hour, 24 hour. 4) Adverse effect |