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CTRI Number  CTRI/2019/04/018413 [Registered on: 03/04/2019] Trial Registered Prospectively
Last Modified On: 24/03/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessement of Pulmonary Recruitment Manoeuver in reducing pain in patients undergoing laparoscopic surgery. 
Scientific Title of Study   Evaluation of Pulmonary Recruitment Manoeuver in Laparoscopy to decrease postoperative pain. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dileep Ramesh Hoysal 
Designation  Associate Professor 
Affiliation  BGS Global Institute Of Medical Sciences 
Address  Department of Surgery, BGS Global institute of medical sciences, No 67, BGS Health and Education city, Uttarahalli main road, Kengeri, Bangalore - 560060

Bangalore
KARNATAKA
560026
India 
Phone  09901829377  
Fax    
Email  dileephoysal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dileep Ramesh Hoysal 
Designation  Associate Professor 
Affiliation  BGS Global Institute Of Medical Sciences 
Address  Department of Surgery, BGS Global institute of medical sciences, No 67, BGS Health and Education city, Uttarahalli main road, Kengeri, Bangalore - 560060

Bangalore
KARNATAKA
560060
India 
Phone  9901829377  
Fax    
Email  dileephoysal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dileep Ramesh Hoysal 
Designation  Associate Professor 
Affiliation  BGS Global Institute Of Medical Sciences 
Address  Department of Surgery, BGS Global institute of medical sciences, No 67, BGS Health and Education city, Uttarahalli main road, Kengeri, Bangalore - 560060

Bangalore
KARNATAKA
560060
India 
Phone  9901829377  
Fax    
Email  dileephoysal@gmail.com  
 
Source of Monetary or Material Support  
BGS Global Institute of Medical Sciences 
 
Primary Sponsor  
Name  BGS Global Institute of Medical Sciences 
Address  No 67, BGS Health and Education city, Uttarahalli Main Road, Kengeri, Bengaluru-560060 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dileep Ramesh Hoysal  BGS Globsl institute of Medical Sciences  No 67, BGS Health and Education city, Uttarahalli Main Road, Kengeri, Bengaluru-560060
Bangalore
KARNATAKA 
9901829377

dileephoysal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Pulmonary Recruitment Manoeuver  Five manual inflations to a maximum airway pressure of 35 cm H2O with the patient in Trendelenburg position (30 degree) versus passive evacuation of CO2 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patients undergoing laparoscopy  
 
ExclusionCriteria 
Details  COPD and pregnant patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the outcome in terms of
a. Vas scores at 4,12,24 hrs
b. Need of second analgesics
c. Pain scores on coughing and deep breathing exercise
 
VAS scores will be assessed at 4th, 12th and 24th hour post operatively. and other parameters will be assessed at 24 hours postoperatively. 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/04/2019 
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   1 Pergialiotis V., Vlachos D.-E. G., Kontzoglou K., Perrea D., Vlachos G. D. Pulmonary Recruitment Maneuver To Reduce Pain After Laparoscopy: A Meta-Analysis Of Randomized Controlled Trials. Surgical Endoscopy. 2015;29(8):2101–2108. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Laparoscopic surgery has gained significant ground in the operative field as a minimally invasive technique it offers the advantages of decrease in the interval until return to daily activity. This is mainly accomplished through reduction of postoperative pain. However, significant proportion of patients still require postoperative analgesia, because these patients seem to suffer from shoulder and/or abdominal pain. The intensity of this type of pain may range from subtle to severe and rarely persists for a period longer than 72 h. Numerous pathophysiologic pathways have been proposed, with carbon dioxide residual and phrenic nerve damage during diaphragmatic stretching being the most accepted theories. While several number of studies have investigated in the past various techniques that could potentially alleviate this type of pain. Over years, several studies have proposed that a simple anesthesiologic maneuver involving pulmonary recruitment after the completion of the laparoscopic procedure might improve the postoperative pain scores of those patients. The pulmonary recruitment maneuver, involves a series of positive pressure ventilations after the completion of the laparoscopic procedure. It increases the intra-abdominal pressure, and consequently reduces the residual gas in the abdominal cavity

 
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