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
|
|
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
|
|
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
signiï¬cant 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, signiï¬cant 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. |