| CTRI Number |
CTRI/2024/01/060995 [Registered on: 01/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| 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
|
A research study to compare pain relief between external oblique intercostal plane block and intravenous morphine in upper abdominal surgeries |
|
Scientific Title of Study
|
A prospective randomised trial comparing postoperative pain relief between bilateral external oblique intercostal plane block and intravenous morphine in patients after upper abdominal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedhyaa S |
| Designation |
Associate Professor |
| Affiliation |
Cancer Institute (WIA),Adyar |
| Address |
B 1 , SDS Pearl, Ajantha Avenue, Kottivakkam,
Room No 10,Surgical Bock, ground floor , Cancer Institute, Sardar Patel Road,Adyar,Chennai
Chennai
TAMIL NADU
6000041
India |
| Phone |
9597423654 |
| Fax |
|
| Email |
nivedhyaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nivedhyaa S |
| Designation |
Associate Professor |
| Affiliation |
Cancer Institute (WIA),Adyar |
| Address |
B 1 , SDS Pearl, Ajantha Avenue, Kottivakkam,
Room No 10,Surgical Bock, ground floor , Cancer Institute, Sardar Patel Road,Adyar,Chennai
Chennai
TAMIL NADU
6000041
India |
| Phone |
9597423654 |
| Fax |
|
| Email |
nivedhyaa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivedhyaa S |
| Designation |
Associate Professor |
| Affiliation |
Cancer Institute (WIA),Adyar |
| Address |
B 1 , SDS Pearl, Ajantha Avenue, Kottivakkam,
Room No 10,Surgical Bock, ground floor , Cancer Institute, Sardar Patel Road,Adyar,Chennai
Chennai
TAMIL NADU
6000041
India |
| Phone |
9597423654 |
| Fax |
|
| Email |
nivedhyaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cancer Institute (WIA),Chennai |
|
|
Primary Sponsor
|
| Name |
Nivedhyaa |
| Address |
Cancer Institute (WIA),Adyar |
| Type of Sponsor |
Other [SELF] |
|
|
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 Nivedhyaa |
Cancer Institute(WIA) |
Room No 10,Department of Anesthesia, Surgical Block, Cancer Institute(WIA) Sardar Patel Road, Near IIT Madras Campus, Adyar
Chennai
TAMIL NADU |
9597423654
nivedhyaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Cancer Institute(WIA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C168||Malignant neoplasm of overlappingsites of stomach, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External Oblique Intercostal Block |
Bilateral ultrasound guided EOIB will be given in the postoperative period if the patient complains of pain with an NRS greater than 3 using a linear ultrasound probe under stict asepsis. Patients in the intervention arm will receive bilateral EOIB with 0.1% bupivacaine bolus of 30 ml volume and 2mg dexamethasone(8) on each side using ultrasound guidance under strict asepsis.Patient will also receive intravenous 3ml saline as a sham medication |
| Comparator Agent |
Intravenous Morphine |
Patients in comparator arm will receive intravenous morphine 0.05mg per Kg as a single stat dose if the NRS of pain score is greater than 3. Patients will also receive a sham ultrasound guided subcutaneous injection of 1ml saline at the site of the EOIB. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
All patients who report moderate to severe upper abdominal pain, defined as a pain score on the numerical rating scale (NRS) of 0-10 as 4 or above for the first three days (POD 0,1,2 and 3) at rest or due to movement or spirometry, in the postoperative period will be included both elective and emergency surgeries
2.Patient who have given informed consent for the procedure.
3.Age of 18 and above
4, Surgeries with upper abdominal incisions including gastric surgeries, splenectomy, cholecystectomy, hepatectomy will be included for the study.
|
|
| ExclusionCriteria |
| Details |
1.renal diseases with elevated serum creatinine level more than 1.5mg%
2.Local skin site infection at the site of epidural or at the site of the EOIPB as identified before surgery
3.Patient refusal to give consent for epidural or blocks
4.History of known allergies to local anaesthetics or morphine
.Suspected bowel obstruction : in this case we cannot use opioids
6.Patient would get discharged in less than 24 hours.
7.Drowsy patient who cannot tell about the pain score appropriately
8.Patients in whom epidural catheter will not be placed (as known preoperatively due to low platelet count or altered coagulation profile)
9.Patients who have been treated with tablet morphine in the preoperative period for 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 |
| Mean requirement of intravenous morphine in either groups as rescue analgesic |
Mean requirement of intravenous morphine in either groups as rescue analgesic upto 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain Intensity Difference
Side Effects
Sum of the pain intensity difference |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/01/2024 |
| 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="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This is a study for comparing postoperative pain relief between the external oblique intercostal plane block and intravenous morphine in upper abdominal surgeries when the patient has a pain score greater than 3.Patients are generally treated with epidural drugs for pain relief.Inspite of that if they have pain in the postoperative period they will be randomised and given either the block or intravenous morphine.Then the difference in pain scores before and after the block will be seen |