| CTRI Number |
CTRI/2026/02/103383 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two techniques of pain relief to reduce shoulder tip pain after gall bladder surgery. |
|
Scientific Title of Study
|
Comparison of Pulmonary recruitment manoeuvre and ultrasound-guided intermediate cervical plexus block in attenuating post-laparoscopic shoulder tip pain under general anaesthesia |
| Trial Acronym |
Comparison of Pulmonary Recruitment manoeuvre and ultrasound guided Intermediate cervical plexus block in attenuating post operative shoulder tip pain under General Anaesthesia
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1333-8594 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Jaiswal |
| Designation |
Junior resident |
| Affiliation |
Teerthankar mahaveer medical College moradabad uttar Pradesh |
| Address |
Room No 204 Dept of Anesthesia teerthankar mahaveer medical College and Research centre N.H
24 Delhi road Moradabad-244001
Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8319139802 |
| Fax |
|
| Email |
nehajjj769@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMukesh kumar Prasad |
| Designation |
HOD and professor |
| Affiliation |
Teerthankar mahaveer medical College |
| Address |
Room no 204 Dept of Anaesthesia teerthankar mahaveer medical College and Research centre
Moradabad
UTTAR PRADESH
24401
India |
| Phone |
919837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMukesh kumar Prasad |
| Designation |
HOD and professor |
| Affiliation |
Teerthankar mahaveer medical College |
| Address |
Room no 204 Dept of Anaesthesia teerthankar mahaveer medical College and Research centre
Moradabad
UTTAR PRADESH
24401
India |
| Phone |
919837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Teerthankar mahaveer medical College |
| Address |
Room no. 1, Surgery Operation Theatre, Department of Anaesthesia,
Teerthankar Mahaveer Medical College,
Moradabad – 244001, Uttar Pradesh, India |
| 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 Mukesh Kumar Prasad |
Teerthankar mahaveer medical College |
Room no 204 Teerthankar mahaveer medical College NH 24
Delhi Moradabad Highway Moradabad Uttar Pradesh
Teerthankar mahaveer medical College moradabad uttar Pradesh
Moradabad
UTTAR PRADESH |
9837624543
mukeshprasad2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE TEERTHANKAR MAHAVEER UNIVERSITY MORADABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pulmonary recruitment maneuvers |
After surgery before extubation, pulmonary recruitment maneuvers given with 5 manual inflation to the maximum pressure of 40cm of H20 at Fio2 100% for 1 minute and monitored till 24 hours. |
| Intervention |
Ultrasound-guided intermediate cervical plexus block |
An intermediate cervical plexus block given with 0.2% ropivacaine 10ml after surgery and monitored till 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving written and informed consent.
Patient scheduled for elective laparoscopic cholecystectomy
Adults 18-65 years
American Society of Anesthesiologists physical status (ASA) grade I-II |
|
| ExclusionCriteria |
| Details |
chronic shoulder or epigastric pain.
previous lung or shoulder surgery.
previous Pneumothorax
BMI more than 30
pregnency |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare duration of analgesia in both groups.
To compare numeric rating score
For pain in both groups in post operative period. |
Data will be recorded at baseline, at the end of surgery after 15min, 30min, 60min, 2 hrs, 6hrs, 12 hrs and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare hemodynamic changes in both groups.
To compare time taken to achieve modified aldrete score 9-10. |
Data will be recorded at the baseline, at the end of surgery immediately after & than 2min, 3min, 4min, 5min, 10min, 15min,20min, 1hour, 2 hour, 3hour, 6hour, 12 hour, 18 hour & 24 hours. |
|
|
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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
After surgery before extubation divided into 2 equal groups Group A received pulmonary recruitment menovers and Group B received ultrasound guided intermediate cervical plexus block given with 10 ml 0.2 percent ropivacaine NRS aldrete discharge score and hemodynamic parameters will be recorded after procedure total rescue analgesia and complications will be noted |