| CTRI Number |
CTRI/2024/06/068315 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Intraperitoneal Insertion of Ropivacaine on Perioperative Peak Expiratory Flow Rate (PEFR) in Patients Undergoing Elective Laparoscopic Cholecystectomy under General Anaesthesia |
|
Scientific Title of Study
|
Effect of Intraperitoneal Instillation of Ropivacaine on Perioperative Peak Expiratory Flow Rate (PEFR) in Patients Undergoing Elective Laparoscopic Cholecystectomy under General Anaesthesia – A randomized, prospective, double blind study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansha shaharyar |
| Designation |
DNB Trainee |
| Affiliation |
Tata Main Hospital Jamshedpur Jharkhand |
| Address |
Tata Main Hospital straight mile road BH area kadma jamshedpur jharkhand C road west northern town bistupur jamshedpur
purbi singhbhum jamshedpur jharkhand
831001
INDIA
Demartment of Anaesthesiology
TATA MAIN HOSPITAL C road west northern town bistupur jamshedpur
purbi singhbhum jamshedpur jharkhand
831001
INDIA
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
9507509906 |
| Fax |
|
| Email |
goldi4220@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr himanshu kumar |
| Designation |
consultant |
| Affiliation |
Tata main hospital |
| Address |
Tata Main Hospital straight mile road BH area kadma jamshedpur jharkhand C road west northern town bistupur jamshedpur
purbi singhbhum jamshedpur jharkhand
831001
INDIA
Demartment of Anaesthesiology
TATA MAIN HOSPITAL C road west northern town bistupur jamshedpur
purbi singhbhum jamshedpur jharkhand
831001
INDIA
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7763807104 |
| Fax |
|
| Email |
himanshu.kumar@tatasteel.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Koshy Verghese |
| Designation |
Senior consultant |
| Affiliation |
Tata Main Hospital jamshedpur jharkhand |
| Address |
Tata Main Hospital straight mile road BH area kadma jamshedpur jharkhand C road west northern town bistupur jamshedpur
purbi singhbhum jamshedpur jharkhand
831001
INDIA
Demartment of Anaesthesiology
TATA MAIN HOSPITAL C road west northern town bistupur jamshedpur
purbi singhbhum jamshedpur jharkhand
831001
INDIA
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
8092099753 |
| Fax |
|
| Email |
drkvarghese@tatasteel.com |
|
|
Source of Monetary or Material Support
|
| Tata Main hospital jamshedpur jharkhand 831001 INDIA |
|
|
Primary Sponsor
|
| Name |
Tata main hospital |
| Address |
Demartment of Anaesthesiology
TATA MAIN HOSPITAL C road west northern town bistupur jamshedpur
purbi singhbhum jamshedpur jharkhand
831001
INDIA |
| Type of Sponsor |
Other [Industrial 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 Mansha shaharyar |
TATA MAIN HOSPITAL Jamshedpur |
Department of Anaesthesiology 2nd floor JGMH building Tata main hospital C Road west northern Town bistupur jamshedpur jharkhand 831001 purbi singhbhum jharkhand
Purbi Singhbhum
JHARKHAND |
9507509906
goldi4220@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Tata Main Hospital |
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 |
0.5% Ropivacaine 20ml |
Group R patients will receive 20 ml 0.5 % Ropivacaine intraperitoneally in the Gall Bladder Fossa prior to port closure Deflation of pneumoperitoneum will be done prior to port closure Patients will be extubated using Myopyrrolate, as per body weight, and when Train-of-Four Ratio of ≥ 0.9 is achieved Rescue analgesic : Inj. Fentanyl 1 µ/kg if NRS ≥ 4. Time to 1st Rescue analgesic
PEFR at 2hr, 6hr, 12hr, 24h
|
| Comparator Agent |
20ml Normal Saline |
Group S patients will receive 20 ml of Normal Saline intraperitoneally in the Gall Bladder Fossa prior to port closure Deflation of pneumoperitoneum will be done prior to port closure Patients will be extubated using Myopyrrolate, as per body weight, and when Train-of-Four Ratio of ≥ 0.9 is achieved Rescue analgesic : Inj. Fentanyl 1 µ/kg if NRS ≥ 4. Time to 1st Rescue analgesic
PEFR at 2hr,6hr, 12hr, 24hr
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing Elective laparoscopic cholecystectomy.
ASA I-II
|
|
| ExclusionCriteria |
| Details |
Patient having OSA.
Patient having cardiopulmonary functional limitation
patient having psychiatric illness.
Emergency surgery
surgical duration less than 1hour & more than 3hours
patient with BMI of more than 30 kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare perioperative PEFR in patients undergoing laparoscopic cholecystectomy under general anaesthesia with and without intraperitoneal instillation of 20 ml of 0.5% Ropivacaine.
|
at 2hour , 6 hour , 12 hour , 24 hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the time to first rescue analgesic in both groups.
|
within 24h |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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
|
BACKGROUND OF STUDY Laparoscopic cholecystectomy – gold standard for gall bladder removal surgeries
Pneumo-peritoneum induced diaphragmatic paresis and irritation results in postoperative pulmonary dysfunction-mainly the inability to produce adequate cough
PEFR was the good spirometric test to predict postoperative complications - reflects the ability to produce an adequate cough
Adequate post-operative analgesia – important for early return of pulmonary function to baseline level.
Traditional methods like NSAIDs, narcotics and periportal local anaesthetic infiltration have no effect on this diaphragmatic irritation RESEARCH QUESTION Does intraperitoneal instillation of Ropivacaine augment faster return to baseline PEFR in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia? OBJECTIVES Primary - To compare perioperative PEFR in patients undergoing laparoscopic cholecystectomy under general anaesthesia with and without intraperitoneal instillation of 20 ml of 0.5% Ropivacaine. Secondary - To find the time to first rescue analgesic in both groups. METHODOLOGY All patients will receive intravenous Dexamethasone 1 mg/kg and intravenous Ondansetron 0.15 mg/kg after excision of gall bladder All patients will receive intravenous Diclofenac 75 mg and intravenous Paracetamol 1 gm at start of port closure Group R patients will receive 20 ml 0.5 % Ropivacaine intraperitoneally in the Gall Bladder Fossa prior to port closure Group S patients will receive 20 ml of Normal Saline intraperitoneally in the Gall Bladder Fossa prior to port closure Deflation of pneumoperitoneum will be done prior to port closure Patients will be extubated using Myopyrrolate, as per body weight, and when Train-of-Four Ratio of ≥ 0.9 is achieved Rescue analgesic : Inj. Fentanyl 1 µ/kg if NRS ≥ 4. Time to 1st Rescue analgesic will be noted. Intraoperative Monitoring (5 mints) Heart rate, Blood pressure – SPB, DBP, MAP, SpO2,End tidal CO2,NM monitoring,Intra-abdominal pressure,Number of intubation attempts,Airway pressures,Analgesics used,Duration of surgery Postoperative Monitoring (5 mints) Heart rate, Blood pressure – SBP, DBP, MAP SpO2, Pain score ( NRS ),Time to 1st rescue analgesic, Rescue analgesics used,Ramsay Sedation Score. PEFR at 2 h, 6 h, 12 h, 24h. Incentive spirometry value
|