| CTRI Number |
CTRI/2025/11/097579 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Ropivacaine and Bupivacaine in subcostal transverse abdominis plane block for post operative analgesia |
|
Scientific Title of Study
|
Comparative study between 0.375% Ropivacaine and 0.25% Bupivacaine in ultrasound guided bilateral subcostal transverse abdominis plane block for post-operative analgesia in patients undergoing 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 |
A Likhil Kumar Reddy |
| Designation |
post graduate trainee |
| Affiliation |
Netaji Subhash Medical College and Hospital |
| Address |
Department of Anesthesia, Netaji Subhash Medical College and Hospital, Amhara, Bihta
Patna
BIHAR
801106
India |
| Phone |
9182292846 |
| Fax |
|
| Email |
dr.likhilkumarreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammad Faseehullah Alam |
| Designation |
Assistant Professor |
| Affiliation |
Netaji Subhash Medical College and Hospital |
| Address |
Department of Anesthesia, Netaji Subhash Medical College and Hospital, Amhara, Bihta
Patna
BIHAR
800025
India |
| Phone |
9155366231 |
| Fax |
|
| Email |
faseehullah.alam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Faseehullah Alam |
| Designation |
Assistant Professor |
| Affiliation |
Netaji Subhash Medical College and Hospital |
| Address |
Department of Anesthesia, Netaji Subhash Medical College and Hospital, Amhara, Bihta
Patna
BIHAR
800025
India |
| Phone |
9155366231 |
| Fax |
|
| Email |
faseehullah.alam@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Netaji Subhash Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Netaji Subhash Medical College and Hospital |
| Address |
Department of Anesthesia, NSMCH, Amhara, Bihta, Patna, Bihar 801106 |
| 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 A Likhil Kumar Reddy |
Netaji Subhash Medical College and Hospital |
Department of Anesthesia, NSMCH, Amhara, Bihta, Patna 801106
Patna
BIHAR |
9182292846
dr.likhilkumarreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Subcostal Transverse Abdominis Plane block will performed at the end of surgery, using standard technique |
Ultrasound guided subcostal transverse abdominis plane block for a period of 15 minutes each side with 22G lumbar puncture needle 20 ml of 0.25% plain Bupivacaine will be given |
| Intervention |
Subcostal Transverse Abdominis Plane block will performed at the end of surgery, using standard technique |
Ultrasound guided subcostal transverse abdominis plane block for a period of 15 minutes each side with 22G lumbar puncture needle 20 ml of 0.375% plain Ropivacaine will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiology 1 and 2 of either sex posted for 4 port laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
patients with history of allergy to local anesthetic drug, psychiatric illness, substance abuse, opioid intolerance, any uncompensated systemic illness, pregnant women |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post operative NRS score for pain |
10 minutes, 30 minutes, 1 hour and then every 4 hours for next 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare postoperative diclofenac sodium need as rescue analgesia
2)To compare hemodynamic between both groups. |
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 2 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.likhilkumarreddy@gmail.com].
- For how long will this data be available start date provided 15-11-2025 and end date provided 15-11-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Post operative pain remains a significant concern following laparoscopic cholecytectomy, affecting patient comfort, recovery, potential for same day discharge and overall satisfaction. With the widespread availability of ultrasound guidance for more accurate localization of transverse abdominis plane, the block is considered as an important technique for reduction of post operative pain in abdominal surgeries. in view of above, this study is being undertaken whether ropivacaine with its inherent advantages is superior to bupivaciane for providing post-operative analgesia when used for tranverse abdominis plane block in patients undergoing laparoscopic cholecytectomy. |