| CTRI Number |
CTRI/2026/03/106132 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided deep rectus sheath block and traditional rectus sheath block for relief of postoperative pain in Laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparison of Ultrasound-Guided Deep Rectus Sheath Block and Traditional Rectus Sheath Block for Postoperative Pain Relief in Laparoscopic Cholecystectomy |
| 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 Pallavi Ahluwalia |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9634750667 |
| Fax |
|
| Email |
drpallaviahluwalia@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Ahluwalia |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur
UTTAR PRADESH
244001
India |
| Phone |
9634750667 |
| Fax |
|
| Email |
drpallaviahluwalia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Ahluwalia |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur
UTTAR PRADESH
244001
India |
| Phone |
9634750667 |
| Fax |
|
| Email |
drpallaviahluwalia@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur Moradabad 244001 India |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur Moradabad |
| Type of Sponsor |
Private 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 Pallavi Ahluwalia |
TMU Hospital |
Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur
Moradabad
UTTAR PRADESH |
9634750667
drpallaviahluwalia@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University- Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deep Rectus Sheath Block |
in Deep Rectus Sheath Block local anaesthetic is deposited deeper, anterior to the posterior rectus sheath |
| Comparator Agent |
Traditional Rectus Sheath Block |
IN Traditional Rectus Sheath Block Local Anaesthetic is deposited between the Rectus abdominal muscle and its posterior Sheath |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving written informed consent
American Society of Anaesthesiologist ASA I or II of either sex
Age group 18–65 years old undergoing Elective laparoscopic cholecystectomy
|
|
| ExclusionCriteria |
|
|
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 compare postoperative Visual Analog Scale(VAS) scores between two groups
|
30 Mins
1 Hr
2 Hr
4 Hr
8 Hr
12 Hr
24 Hr
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare hemodynamic Parameters between two groups
To assess the time to first rescue analgesia.
To compare total Tramadol requirement in the first 24 hours postoperatively.
To evaluate patient satisfaction score
To compare the Modified Visceral pain score between two groups
|
30 Mins
1 Hr
2 Hr
4 Hr
8 Hr
12 Hr
24 Hr
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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 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
|
The Deep Rectus Sheath Block is a novel modificatiom which may provide better analgesia and also may provide visceral relief and would provide longer analgesia so we will be comparing the deep rectus sheath block with the traditional rectus sheath block for post operative analgesia in the patients undergoing Laparoscopic Cholecystectomy |