| CTRI Number |
CTRI/2025/10/096456 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see which injection technique gives better pain relief and decrease need of pain killer after gallbladder surgery i.e (External Oblique Intercostal Block or Subcostal Transversus Abdominis Block)” |
|
Scientific Title of Study
|
Evaluating the need for Rescue Analgesia with US-Guided External Oblique Intercostal (EOI) Block versus US-Guided Subcostal Transversus Abdominis (TAP) Block in Patients Undergoing Laparoscopic Cholecystectomy. A Prospective 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 |
DR ABHA SINGH |
| Designation |
Assistant Professor |
| Affiliation |
United institute of medical sciences Prayagraj |
| Address |
Room no 1 , department of anaesthesia , 2nd floor , OT Complex , united institute of medical sciences, Allahabad, Uttar Pradesh
Room no 1 , department of anaesthesia , 2nd floor , OT Complex , united institute of medical sciences, Allahabad, Uttar Pradesh
Allahabad
UTTAR PRADESH
211012
India |
| Phone |
9956742300 |
| Fax |
|
| Email |
drabhasingh1990@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHA SINGH |
| Designation |
Assistant Professor |
| Affiliation |
United institute of medical sciences Prayagraj |
| Address |
Room no 1 , department of anaesthesia , 2nd floor , OT Complex , united institute of medical sciences, Allahabad, Uttar Pradesh
Room no 1 , department of anaesthesia , 2nd floor , OT Complex , united institute of medical sciences, Allahabad, Uttar Pradesh
Allahabad
UTTAR PRADESH
211012
India |
| Phone |
9956742300 |
| Fax |
|
| Email |
drabhasingh1990@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHA SINGH |
| Designation |
Assistant Professor |
| Affiliation |
United institute of medical sciences Prayagraj |
| Address |
Room no 1 , department of anaesthesia , 2nd floor , OT Complex , united institute of medical sciences, Allahabad, Uttar Pradesh
Room no 1 , department of anaesthesia , 2nd floor , OT Complex , united institute of medical sciences, Allahabad, Uttar Pradesh
Allahabad
UTTAR PRADESH
211012
India |
| Phone |
9956742300 |
| Fax |
|
| Email |
drabhasingh1990@yahoo.in |
|
|
Source of Monetary or Material Support
|
| United institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Dr Abha Singh |
| Address |
Room no 1 , department of anaesthesia , 2nd floor , OT Complex , united institute of medical sciences, Allahabad, Uttar Pradesh 211012 |
| Type of Sponsor |
Other [] |
|
|
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 ABHA SINGH |
united institute of medical sciences |
Room no 1 , department of anaesthesia , 2nd floor , OT Complex , united institute of medical sciences, Allahabad, Uttar Pradesh 211012
Allahabad
UTTAR PRADESH |
9956742300
drabhasingh1990@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE UNITED INSTITUTE OF MEDICAL SCIENCES |
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 |
| Comparator Agent |
ultrasound guided external oblique intercostal block with ultrasound guided subcostal Transverse abdominal plane block |
Bilateral Ultrasound-guided injection between the external and internal oblique muscles at the 10th to 11th rib level, using a mixture of 10 mL of 0.2 percentage Ropivacaine with 5 ml 2 percentage lignocaine on each side will be given in one group and in another group Bilateral Ultrasound guided injection along the subcostal margin between transversus abdominis and rectus sheath, using a mixture of 10 mL of 0.2 percentage Ropivacaine with 5 ml 2percentage lignocaine on each side will be given |
| Intervention |
we are giving drugs through blocks that is a mixture of 10 mL of 0.2% Ropivacaine + 5 ml 2% lignocaine in both the group |
using a mixture of 10 mL of 0.2% Ropivacaine + 5 ml 2% lignocaine ultrasound guided external oblique intercostal block and subcostal TAP block will be given bilaterally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
age 18 to 65
willing to give informed consent
asa grade 1 and 2
elective surgery
|
|
| ExclusionCriteria |
| Details |
age less than 18 and above 65
Allergy to local anaesthetics.
Coagulopathy
BMI more than 30 Kg/m2
Infection at block site.
Chronic opioid use or analgesic therapy
Cognitive impairment.
Severe Renal & Liver dysfunction.
Pregnancy & lactating
Conversion to open cholecystectomy.
|
|
|
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 |
Time to first rescue dose of Tramadol.
Total Tramadol consumption within 24 hours postoperatively.
|
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NRS pain scores at the set intervals:1 ,6, 12, 18, 24 hours postoperatively.
|
within 24 hrs |
Incidence of PONV, neurovascular injury, block failure, hematoma , pneumothorax or LAST.
|
24 hours |
| Patient satisfaction level using Likert scale. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study focus on pain relief and need of rescue analgesia in patients after laproscopic cholecystectomy with the help of fascial plane block. this study will compare two blocks that is external oblique intercostal block with subcostal transverse abdominis plane block using 0.2 percentage ropovacaine with 2 percentage lignocaine 15 ml total drug in terms of better pain relief at the set interval of 1,6,12 ,18,24 hours after surgery. patient satisfaction level will be judged with help of likerts scale. |