| CTRI Number |
CTRI/2025/07/090105 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study on pain relief using two types of abdominal nerve blocks after laparoscopic kidney removal surgery. |
|
Scientific Title of Study
|
Comparison of postoperative analgesia of laparoscopic-assisted and ultrasound-guided transversus abdominis plane block in patients undergoing laparoscopic nephrectomy. |
| 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. Ankita trivedi |
| Designation |
post graduate student |
| Affiliation |
ABVIMS and RML hospital New Delhi |
| Address |
Room no 304
PGI building
Department of anaesthesia
ABVIMS and RML hospital
New Delhi
DELHI
110001
India |
| Phone |
9521857105 |
| Fax |
|
| Email |
trivediankita0312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rupesh yadav |
| Designation |
professor |
| Affiliation |
ABVIMS and RML hospital New Delhi |
| Address |
room 304
PGI building
Department of Anaesthesia
ABVIMS and RML Hospital
New Delhi
DELHI
110001
India |
| Phone |
09460720444 |
| Fax |
|
| Email |
drrupesh.yadav98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rupesh yadav |
| Designation |
professor |
| Affiliation |
ABVIMS and RML hospital New Delhi |
| Address |
Room no 304
PGI Building
Department of Anaesthesia
ABVIMS and RML Hospital
New Delhi
DELHI
110001
India |
| Phone |
09460720444 |
| Fax |
|
| Email |
drrupesh.yadav98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
ABVIMS and RML Hospital
New Delhi
|
|
|
Primary Sponsor
|
| Name |
ABVIMS and RML hospital New Delhi |
| Address |
ABVIMS and RML hospital
department of anaesthesia |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rupesh yadav |
ABVIMS and RML hospital New Delhi |
Department of Anaesthesia
PGI building
New Delhi
New Delhi
DELHI |
09460720444
drrupesh.yadav98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, ABVIMS and RML Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transversus abdominis plane block |
20 ml of 0.25 percent bupivacaine given under direct laparoscopic visualization at the end of laparoscopic nephrectomy before release of pneumoperitoneum. |
| Comparator Agent |
Transversus abdominis plane block |
20 ml of 0.25 percent bupivacaine given under ultrasound guidance at the end of surgery before extubation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(1) ASA grade 1 and 2
(2) Scheduled for elective laparoscopic Nephrectomy.
|
|
| ExclusionCriteria |
| Details |
1.History of a local anesthetic allergy
2.History of opioid or alcohol addiction
4.BMI more than 30
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The difference in VAS score will be observed after laparoscopic nephrectomy using either laparoscopic-assisted or ultrasound-guided transversus abdominis plane block. |
At 6, 12, and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The duration of the analgesia in both the group |
At 6, 12, and 24 hours postoperatively |
| The total consumption of rescue analgesia in both the groups |
At 6, 12, and 24 hours postoperatively |
| Time taken for administration of block in both the groups |
|
| Incidence of post-op nausea and vomiting in both the groups |
At 6, 12, and 24 hours postoperatively |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="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
|
This study compares the effectiveness of two techniques for performing transversus abdominis plane block in patient undergoing laparoscopic nephrectomy. One group will receive the block using laparoscopic assistance while other group will receive it under ultrasound guidance. The aim is to assess which technique provides better post operative pain relief. The study will evaluate pain score, duration of pain relief, amount of rescue pain medication used, and time taken to perform the block. The finding may help determine if laparoscopic assisted technique is suitable alternative to ultrasound guided method in clinical practice. |