| CTRI Number |
CTRI/2025/05/087782 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [technique] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparision of pain levels after laparoscopic cholecystectomy surgery using nerve blocks at two different areas with ultrasound |
|
Scientific Title of Study
|
Comparision of analgesic efficacy with external oblique intercoastal plus rectus sheath blocks versus subcoastal transversus abdominis plane block following laparoscopic cholecystectomy :A randomised study |
| Trial Acronym |
EOIB &RSvs SCTAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabhu Gnapika Putta |
| Designation |
Assistant professor |
| Affiliation |
Sri Venkateswara Medical college |
| Address |
Sri Venkateswara Medical college,
Alipiri,
Tirupati
Sri Venkateswara Medical college,
Alipiri,
Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493628668 |
| Fax |
|
| Email |
gnapika.putta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prabhu Gnapika Putta |
| Designation |
Assistant professor |
| Affiliation |
Sri Venkateswara Medical college |
| Address |
Sri Venkateswara Medical college,
Alipiri,
Tirupati
Sri Venkateswara Medical college,
Alipiri,
Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493628668 |
| Fax |
|
| Email |
gnapika.putta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabhu Gnapika Putta |
| Designation |
Assistant professor |
| Affiliation |
Sri Venkateswara Medical college |
| Address |
Sri Venkateswara Medical college,
Alipiri,
Tirupati
Sri Venkateswara Medical college,
Alipiri,
Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493628668 |
| Fax |
|
| Email |
gnapika.putta@gmail.com |
|
|
Source of Monetary or Material Support
|
| SVRRGGH, alipiri, Tirupati |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Medical college |
| Address |
Alipiri,
Tirupati,
Andhra pradesh. |
| Type of Sponsor |
Government 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 |
| DrPrabhu Gnapika |
General surgery operation theatres of SVRRGGH, Alipiri, Tirupati |
Alipiri,
Tirupati
Chittoor
ANDHRA PRADESH |
9493628668
gnapika.putta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics comittee |
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 |
| Intervention |
ultrasound guided fascial plane blocks for post operative pain management |
external oblique intercoastal plus rectus sheath block versus subcoastal transversus abdominis plane block with 20 ml of o.25%bupivacaine |
| Comparator Agent |
ultrasound guided fascial plane blocks using 0.25% bupivacaine |
external oblique intercoastal plus rectus sheath block versus subcoastal transversus abdominis plane block with 20 ml of o.25%bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Whoever undergoing elective laparoscopic cholecystectomy surgery |
|
| ExclusionCriteria |
| Details |
Lack of consent
Pregnant & lactating mothers
Concverted to open cholecystectomy surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative pain asessment using numerical rating scale |
Pain asessment using numerical rating scale at 1st hour, 2nd hour,4th hour,6th hour,12th hour, 24th hour postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total rescue analgesia needed in 24 hours |
24th hr post operatively |
|
|
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)
|
15/08/2025 |
| 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="0"
Months="9"
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
|
Ultrasound guided fascial plane blocks have been recently incorporated into multimodal analgesia for laparoscopic abdominal surgeries because of side effects of opioids. The aim of the study is to investigate the analgesic efficacy of ultrasound guided right external oblique intercoastal block plus rectus sheath block versus ultrasound guided bilateral subcoastal transversus abdominis plane block for postoperative pain relief following laparoscopic cholecystectomy cases in terms of time to the first request of first rescue analgesia, total analgesic requirement in first 24 hours. |