| CTRI Number |
CTRI/2025/08/093091 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
using USG in laparoscopic cholecystectomy to compare posterior and subcostal Transverse abdominis plane block |
|
Scientific Title of Study
|
Comparison of efficacy of posterior and subcostal techniques of ultrasound-guided transverse abdominis plane block in laparoscopic cholecystectomy-Randomized double-blinded study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G P Kirankumar |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula vinayagar medical college and hospital |
| Address |
Room no 109
Hospital 1st floor
Department of anaesthesiology
Sri manakula vinayagar medical college and hospital
Kalitheerthalkuppam
Puducherry 605107
Room no 109
Hospital 1st floor
Department of anaesthesiology
Sri manakula vinayagar medical college and hospital
Kalitheerthalkuppam
Puducherry 605107
Pondicherry PONDICHERRY 605107 India |
| Phone |
9676001102 |
| Fax |
|
| Email |
kirankumargp123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ranjan R V |
| Designation |
Professor |
| Affiliation |
Sri Manakula vinayagar medical college and hospital |
| Address |
Room no 109
Hospital 1st floor
Department of anaesthesiology
Sri manakula vinayagar medical college and hospital
Kalitheerthalkuppam
Puducherry 605107
Room no 109
Hospital 1st floor
Department of anaesthesiology
Sri manakula vinayagar medical college and hospital
Kalitheerthalkuppam
Puducherry 605107
Pondicherry PONDICHERRY 605107 India |
| Phone |
9600823772 |
| Fax |
|
| Email |
ranjanrv2005@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
G P Kirankumar |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula vinayagar medical college and hospital |
| Address |
Room no 109
Hospital 1st floor
Department of anaesthesiology
Sri manakula vinayagar medical college and hospital
Kalitheerthalkuppam
Puducherry 605107
Room no 109
Hospital 1st floor
Department of anaesthesiology
Sri manakula vinayagar medical college and hospital
Kalitheerthalkuppam
Puducherry 605107
PONDICHERRY 605107 India |
| Phone |
9676001102 |
| Fax |
|
| Email |
kirankumargp123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
G P kirankumar |
| Address |
Room no 109
Hospital 1st floor
Department of anaesthesiology
Sri manakula vinayagar medical college and hospital
Kalitheerthalkuppam
Puducherry 605107
|
| 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 G P Kirankumar |
Sri manakula vinayagar medical college |
Room no 109
Hospital 1st floor
Department of anaesthesiology
Kalitheerthalkuppam
Puducherry 605107
Pondicherry PONDICHERRY |
9676001102
kirankumargp123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of efficacy of posterior and subcostal techniques of ultrasound-guided transverse abdominis plane block in laparoscopic cholecystectomy |
Posterior and subcostal transverse abdominis plane block will be compared using USG guidance in laparoscopic cholecystectomy |
| Intervention |
Comparison of efficacy of posterior and subcostal techniques of ultrasound-guided transverse abdominis plane block in laparoscopic cholecystectomy |
Using ultrasound in laparoscopic cholecystectomy cases, sub costal and posterior TAP block will be performed in 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult age group 18 to 60 years
ASA PS I and II
Either gender
Patient posted for elective Laparoscopic Cholecystectomy
|
|
| ExclusionCriteria |
| Details |
Patients who refuse to give consent
Patients with coagulopathy renal dysfunction pregnancy
Patients with allergy to local anaesthetics
Patients with psychiatric illness substance abuse
History of opioid dependence
Laparoscopic converted to open cholecystectomy
Duration of surgery more than 3 hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of postoperative analgesia between posterior and subcostal approaches to ultrasound guided TAP block after laparoscopic cholecystectomy |
Post operative analgesia using VAS score 1hr 2hr 4 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the hemodynamic stability heart rate blood pressure SPO2 VAS between the two groups
To look for complications like LAST
|
intra operative 15 30 45 60 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2025 |
| 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="6" 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
|
Laparoscopic cholecystectomy has become the standard of care for gallbladder diseases due to its minimally invasive nature which results in reduced postoperative pain early recovery and decreased hospital stay compared to open surgery However despite its minimally invasive nature patients often experience moderate to severe postoperative pain particularly in the early hours after surgery Effective management of this pain is critical especially as laparoscopic cholecystectomy is commonly performed as an outpatient procedure necessitating rapid recovery and discharge In recent years there has been increasing interest in regional anesthesia techniques such as the transversus abdominis plane block as part of multimodal analgesia strategies TAP block involves the injection of local anesthetic between the internal oblique and transversus abdominis muscles to block afferent nerves of the anterior abdominal wall This technique provides a more localized analgesic effect and reduces the requirement for systemic opioids thus minimizing opioid-related side effects
The TAP block was initially performed using a landmark based blind technique but advancements in ultrasound technology have improved the safety and accuracy of this procedure Two main ultrasound-guided techniques have emerged the posterior and subcostal techniques The posterior TAP block is administered near the triangle of Petit and predominantly provides analgesia T10 to L1 dermatomes making it more suitable for abdominal surgeries On the other hand the subcostal TAP block targets higher dermatomes T7 to T12 and is thus more effective for upper abdominal procedures Given the increasing reliance on outpatient surgery models and the need for effective opioid sparing analgesia evaluating the most effective TAP block approach for laparoscopic cholecystectomy remains an area of ongoing clinical interest This thesis aims to further investigate and compare the efficacy of these regional techniques in providing optimal postoperative analgesia for patients undergoing laparoscopic cholecystectomy |