| CTRI Number |
CTRI/2024/07/070400 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on reduction of post operative shoulder pain after laparoscopic surgeries using pulmonary recruitment manuever |
|
Scientific Title of Study
|
An open labelled Randomized control trial to assess the effectiveness of pulmonary recruitment manoeuvre in reduction of postoperative shoulder pain in laparoscopic surgeries |
| 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 M Kavimugan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS,Nagpur |
| Address |
Room No.202, Departement of General Surgery,All India Institute of Medical Sciences,Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7708658774 |
| Fax |
|
| Email |
kavimugan8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupendra Mehra |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,Nagpur |
| Address |
205,Department of General Surgery,All India Institute of Medical Sciences,Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9822817958 |
| Fax |
|
| Email |
drbhupi_mehra@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Kavimugan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS,Nagpur |
| Address |
202,Department of General Surgery,All India Institute of Medical Sciences,Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7708658774 |
| Fax |
|
| Email |
kavimugan8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No.202,Department of General Surgery,OPD building,All India Institute of Medical Sciences,MIHAN, Dahegaon, Nagpur, Maharashtra,India-441108 |
|
|
Primary Sponsor
|
| Name |
Dr Kavimugan M |
| Address |
Room No.202,Department of General Surgery, OPD Building, All India Institute Of Medical Sciences,MIHAN,Dahegaon, Nagpur, Maharashtra, India-441108.
|
| 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 Kavimugan |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NAGPUR |
Room No.202,Department of General Surgery, OPD Building, All India Institute Of Medical Sciences,MIHAN,Dahegaon,Nagpur,Maharashtra,India-441108.
Nagpur
MAHARASHTRA |
7708658774
kavimugan8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pulmonary recruitment manuoever |
Inflation of the lungs and descent of the diaphragm during the PRM causes the intra-abdominal pressure to increase, mechanically facilitating exsufflation of intra-abdominal CO2
Intervention:Pulmonary Recruitment manuever along with routine CO2 exsufflation methods for 1 minute.
Total Duration of Study-18 months |
| Comparator Agent |
Routine CO2 exsuflation method |
Post laparoscopic surgery, pneumoperitoneum will be let out from abdomen using abdominal compression for 1 minute
Total Duration of Study-18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing laparoscopic surgeries in age group of 18-
65 years in ASA classification I and II
|
|
| ExclusionCriteria |
| Details |
Patients below 18 years and above 65 years or with hepatic,pulmonary or renal pathology or ASA classification more than 2 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Postoperative shoulder Pain monitored using Visual analog Scale |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Hospital Stay |
18 months |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/07/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included kavimugan8@gmail.com).
- For how long will this data be available start date provided 01-03-2026 and end date provided 31-12-2036?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
shoulder pain and pain in the upper abdomen are common complaints after laparoscopy, sometimes surpassing the pain at incision sites. The incidence of shoulder pain ranges from 35 to 80%. Post-laparoscopic shoulder pain is caused by retention of carbon dioxide in the abdomen, which irritates the phrenic nerve and diaphragm, causing referred pain in the shoulder and in the upper abdomen. A promising strategy to reduce this post-laparoscopic shoulder pain is the pulmonary recruitment manoeuvre, which indirectly increases intraperitoneal pressure and thereby facilitates removal of residual carbon dioxide.
Null Hypothesis-Pulmonary recruitment manoeuvre is not effective in reducing postoperative shoulder pain in patients undergoing laparoscopic surgeries
|