| CTRI Number |
CTRI/2024/11/076231 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Other |
|
Public Title of Study
|
To find out which is the better method of pain relief, either when local anesthesia is injected in between abdominal wall muscles or when it is given at incision sites only |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of Right sided external oblique intercostal plane block and bilateral rectus sheath block with that of local port site infiltration in laparoscopic cholecystectomy - A Prospective Observational 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 Harshita Sachdev |
| Designation |
Junior resident |
| Affiliation |
AIIMS, Bilaspur (H.P.) |
| Address |
4th floor, OT complex, department of anaesthesiology and critical care
AIIMS Bilaspur (H.P.)
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
9630630051 |
| Fax |
|
| Email |
harshitasachdev999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalakshmi Sivapurapu |
| Designation |
Additional professor and Head of department |
| Affiliation |
AIIMS, Bilaspur |
| Address |
4th floor, OT complex, department of anaesthesiology and critical care
AIIMS Bilaspur (H.P.)
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
7305955162 |
| Fax |
|
| Email |
prerana1010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Gurnal |
| Designation |
Assistant professor |
| Affiliation |
AIIMS, Bilaspur |
| Address |
4th floor, OT complex, department of anaesthesiology and critical care
AIIMS Bilaspur (H.P.)
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
9418627804 |
| Fax |
|
| Email |
poojagurnal2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Block D, 4th floor, OT complex, Anaesthesia department, AIIMS Bilaspur, 174001, Himachal Pradesh, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Bilaspur HP |
| Address |
Block D, 4th floor, Ot complex, Department of anaesthesiology and critical care, AIIMS Bilaspur, 174001,
Himachal Pradesh, 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 Harshita Sachdev |
AIIMS Bilaspur |
Block -D 4th floor OT complex, department of anaesthesiology and critical care, AIIMS Bilaspur
Bilaspur
HIMACHAL PRADESH |
9630630051
harshitasachdev999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Biomedical and Health Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ASA I and II patients undergoing elective laparoscopic cholecystectomy |
Local port site infiltration will be given by 0.2% ropivacaine |
| Intervention |
ASA I and II patients undergoing elective laparoscopic cholecystectomy |
Right sided external oblique intercostal plane block and bilateral Rectus sheath block will be given using 0.2% ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-80 years
2. ASA I and II grade patients
3. Male and female
4. Patients scheduled to undergo laparoscopic cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Allergy to local anaesthetic
2. Refusal of consent for study by the patient
3. Infection in the block application area |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the duration of analgesia after administering right sided external oblique intercostal plane block and bilateral rectus sheath block as compared to local port site infiltration |
Post op 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Study the quality of analgesia as depicted by total dose of morphine consumption
2. Evaluate pain by numerical rating scale at rest and on coughing
3. Assess post operative nausea vomiting in both groups |
Post op 12 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/10/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
Modification(s)
|
We are taking ASA grade I and II patients undergoing elective laparoscopic cholecystectomy surgery. One group of patients will be given ultrasound guided Right sided external oblique intercostal plane block and bilateral rectus sheath block with 0.2% ropivacaine and other group of patients will be given local port site infiltration with 0.2% ropivacaine after giving general anaesthesia for post operative pain relief. Duration of analgesia will be compared in both the groups. Post operative pain will be assessed by numerical rating scale at rest and on coughing for 12 hours, if pain occurs will be relieved by bolus dose of injection Morphine (0.1mg/kg) slow iv and subsequently connected to PCA pump programmed to deliver the injection morphine (1mg/ml dilution) and post operative nausea vomiting will be relieved by injection ondansetron 0.04mg/kg iv SOS. |