| CTRI Number |
CTRI/2025/01/078977 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of continuous delivering catheter placed in the abdominal wall compared to a catheter placed in back on post-operative blood pressure stability in patients undergoing surgery via vertical stomach incision |
|
Scientific Title of Study
|
Effect of Continuous Rectus Sheath Block Compared To Epidural Analgesia on Post-Operative Hemodynamic Stability in Patients Undergoing Elective Midline Laparotomy-A Randomised Controlled 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 |
Lakshme Sanjana Karthik |
| Designation |
Post Graduate, MD Anaesthesia |
| Affiliation |
SRM Medical College and Research Center |
| Address |
Department of Anaesthesiology
SRM Medical College and Research Center
SRM Hospital,Potheri
kattankulathur
Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8056482583 |
| Fax |
|
| Email |
lk8065@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
B Gayathri |
| Designation |
professor and Head of Anaesthesiology |
| Affiliation |
SRM Medical College and Research Center |
| Address |
dept of anaesthesiology
SRM Medical College and Hospital
dr B C Roy hostel
Potheri
kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
hod.anaest.ktr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
B Gayathri |
| Designation |
professor and Head of Anaesthesiology |
| Affiliation |
SRM Medical College and Research Center |
| Address |
dept of anaesthesiology
SRM Medical College and Hospital
dr B C Roy hostel
Potheri
kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
hod.anaest.ktr@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Center, SRM Nagar, Potheri, Kattankulathur, Kancheepuram district,Tamil Nadu, 603203, India |
|
|
Primary Sponsor
|
| Name |
SRM Medical College and Reasearch Center |
| Address |
SRM Nagar
Potheri
kattankulathur
603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lakshme Sanjana Karthik |
SRM Institute of Science and Technology |
Room no;209
B-Block
2nd floor, Department of Anaesthesiology, SRM Medical College and Research Institute, Kattankulathur, Kancheepuram, Tamil Nadu 603203 India
Potheri
Kattankulathur
603203
Kancheepuram
TAMIL NADU |
8056482583
lk8065@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee- Student |
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 |
bilateral rectus sheath block |
post operatively a PCA pump will continuously deliver 5ml/hr per side of ropivacaine solution for 48 hours. breakthrough pain is addressed with 2ml bolus set at a lock out period of 20 mins |
| Comparator Agent |
epidural |
pre operative epidural placed at T12 level, catheter inserted to 5cm and post op infusion of 0.2% ropivacaine and 2mcg/ml fentanyl at 0.1ml/hour/kg of ideal body weight |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
elective surgery
hemodynamically stable |
|
| ExclusionCriteria |
| Details |
patients with spine abnormalities
difficult airway
patient on ventilators
pregnant women
contraindications to ropivacaine or epidural analgesia
ASA PS III including implanted pacemaker, ESRD on dialysis
not consenting
known bleeding diasthesis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the effect of rectus sheath block compared to epidural analgesia on post operative hemodynamic stability in patients undergoing elective mid-line laparotomy |
every 2 hours for the 48 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
pain relief
incidence of DVT
Appearance of bowel movements
length of ICU stay |
6th hourly
12th hourly
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
14/02/2025 |
| 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="1"
Months="6"
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
|
A total of 64 patients that are over the age of 18, consenting and undergoing elective surgery under ASA PS 1-3 will be enrolled in this RCT. Patients will be divided into two groups-control and trial. The control group will receive an epidural catheter placed pre-operatively and activated post operatively. They will receive a patient controlled analgesia pump that provides a continuous infusion, two ml boluses at a lock out period of up to twenty minutes. the trial group will receive a bilateral rectus sheath block postoperatively and a patient controlled analgesia pump will deliver five ml per hour per side of the same ropivacaine solution. the bolus and lockout period will be set the same as the control group. post operatively data will be collected by observation of the vital parameters at regular time intervals for forty eight hours. |