| CTRI Number |
CTRI/2024/03/063927 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of different pulmonary recruitment manoeuvre pressures on post-laparoscopic shoulder pain |
|
Scientific Title of Study
|
A randomized controlled double blind trial comparing effect of different pulmonary recruitment manoeuvre pressures on post-laparoscopic shoulder pain |
| 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 Nithu Dina Joseph |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed to be University |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7012551615 |
| Fax |
|
| Email |
nithudinajoseph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Konnur |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
shwetajm81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithu Dina Joseph |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed to be University |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7012551615 |
| Fax |
|
| Email |
nithudinajoseph@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nithu Dina Joseph |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Dhankawadi
Pune |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shweta Konnur |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University
Dhankawadi
Pune |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nithu Dina Joseph |
Bharati hospital and Research Centre |
Major operation theatre, 3rd floor, Bharati Hospital and Research Centre, pune-satara road, pincode:411043
Pune
MAHARASHTRA |
7012551615
nithudinajoseph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, (2) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (3) ICD-10 Condition: K420||Umbilical hernia with obstruction,without gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
pulmonary recruitment maneouvre (PRM) for post-laparoscopic shoulder pain |
control group will receive routine method of removing carbon dioxide by passive exsufflation by applying gentle abdominal pressure by surgeon |
| Intervention |
pulmonary recruitment maneouvre (PRM) for post-laparoscopic shoulder pain |
Group I will receive PRM pressure of 20cmH2O
Group II will receive PRM pressure of 40cmH2O |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients posted for laparoscopic surgeries under GA of duration upto 4 hours |
|
| ExclusionCriteria |
| Details |
Patient refusal to participate in study, BMI more than 30, patients with chronic shoulder pain, history of previous shoulder surgery, COPD/respiratory pathologies, patients with hemodynamic instability, high intracranial pressure and right heart failure, pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of two different pulmonary recruitment manoeuvre pressures on intensity of post-laparoscopic shoulder pain |
post operative hemodynamic assessment at 1 min, 3min and 5 mins after the maneouvre is performed, followed by vas score, total analgesia consumption and side effect assessment postoperatively upto 24 hours (every 2 hours for first 12 hours, every 6 hours for next 12 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters before and after PRM |
Intra-operatively before PRM and 1,3 and 5 mins after PRM |
| Total consumption of analgesics in 24 hours in all groups |
post-operatively upto 24 hours |
| side effects like nausea and vomiting |
post-operatively upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
16/03/2024 |
| 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 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
|
A prospective randomized double blind trial will be conducted in ASA I and II patient posted for laparoscopic surgeries under general aneaesthesia. Primary aim is to assess effect of different pulmonary recruitment manoeuvre pressures on post-laparoscopic shoulder pain. Secondary objectives include monitoring hemodynamic parameters before and after PRM, total consumption of analgesics in 24 hrs in all groups and side effects like nausea and vomiting. Patients will be divided into 3 groups on the basis of a computer generated randomisation table: Group 1 - will receive PRM of 20cmH2O in addition to routine method Group 2- will receive PRM of 40cmH2O in addition to routine method Group 3 - will receive routine method of removing CO2 by passive exsufflation by applying gentle abdominal pressure by surgeon |