| CTRI Number |
CTRI/2023/03/050444 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
06/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the severity of post operative pain and changes in heart rate, respiratory rate, blood pressure, etc intra-operatively in low pressure and standard pressure pneumoperitoneum (insufflation of CO2 gas in abdominal cavity for better view) in all laparoscopic abdominal surgeries among adults |
|
Scientific Title of Study
|
Comparison of effects of low pressure and standard pressure pneumoperitoneum
with respect to post operative pain and intra operative hemodynamic changes; A single blinded randomized controlled trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KABILAN S |
| Designation |
Post Graduate Resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Room no. 113, PG annexe,
Dept of General surgery,
Pondicherry Institute of Medical sciences
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7904160938 |
| Fax |
|
| Email |
kabilan.selvan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peter Manoharan |
| Designation |
Professor, General Surgery |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Medical Superintendent quarters,
Dept. Of General surgery,
Pondicherry Institute of medical sciences
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9447591100 |
| Fax |
|
| Email |
peternirmala@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
KABILAN S |
| Designation |
Post Graduate Resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Room no. 113, PG annexe
Dept of General Surgery,
Pondicherry Institute of medical sciences
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7904160938 |
| Fax |
|
| Email |
kabilan.selvan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Kabilan S |
| Address |
Room no 113, PG annexe,
Dept of General surgery,
Pondicherry Institute of medical sciences,
Puducherry 605014 |
| 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 Kabilan |
Pondicherry Institute of Medical Sciences, Puducherry |
Department of General Surgery,
Ward No. 8 / SICU / ICU, PIMS hospital
Village No. 20, Ganapathichettikulam, Kalapet, Puducherry - 605014
Pondicherry
PONDICHERRY |
7904160938
kabilan.selvan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Pondicherry institute of medical sciences |
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 |
| Intervention |
Low pressure pneumoperitoneum |
8 to 10 mmHg |
| Comparator Agent |
Standard pressure pneumoperitoneum |
13 to 15 mmHg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing laparoscopic abdominal surgeries |
|
| ExclusionCriteria |
| Details |
1. Conversion of laparoscopic abdominal surgery to open
2. Epidural analgesia
3. Intraoperative cardiac or pulmonary complications
4. Sepsis and septic shock |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The severity of post operative pain will be significantly lower in low pressure pneumoperitoneum as compared to the standard pressure pneumoperitoneum in laparoscopic abdominal surgeries among adults |
2, 8, 24hrs post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The severity of intraoperative hemodynamic changes will be significantly lower in low pressure pneumoperitoneum as compared to the standard pressure pneumoperitoneum in laparoscopic abdominal surgeries among adults |
at start of surgery, at start of pneumoperitoneum creation, at 5, 10, 15, 30, 45, 60, 75, 90 min, 2hrs, 3hrs, 4hrs post pneumoperitoneum creation |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
10/03/2023 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is intended to come to a conclusion if low pressure pneumoperitoneum is sufficient enough for all laparoscopic abdominal surgeries, whether it will have lesser post operative pain and lesser intra operative hemodynamic changes |