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CTRI Number  CTRI/2024/11/077018 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of medicines to reduce post operative pain after laparoscopic procedure  
Scientific Title of Study   A comparative study to evaluate the pre-emptive analgesia by intra peritoneal instillation of Ropivacaine with dexamethasone versus Ropivacaine alone versus Normal saline in patients undergoing laparoscopic cholecystectomy – A Randomized clinical trial  
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 Soumya Patted  
Designation  Post graduate  
Affiliation  Bangalore Medical College and Research Institute, RGUHS University, Karnataka  
Address  Major OT complex,3rd floor, MPB building,Department of Anaesthesia,Bangalore Medical College and Research Institute Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  8884839682  
Fax    
Email  soumyacp121@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samudyatha T J 
Designation  Assistant Professor  
Affiliation  Bangalore Medical College and Research Institute  
Address  Major OT complex 3rd floor MPB building,Department of Anaesthesia Bangalore Medical College and Research Institute Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9686216626  
Fax    
Email  drsamudyatha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Samudyatha T J 
Designation  Assistant Professor  
Affiliation  Bangalore Medical College and Research Institute  
Address  Major OT complex 3rd floor MPB building Department of Anaesthesia, Bangalore Medical College and Research Institute Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9686216626  
Fax    
Email  drsamudyatha@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 
 
Primary Sponsor  
Name  Dr Soumya Patted  
Address  Bangalore Medical College and Research Institute Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002  
Type of Sponsor  Other [Self ] 
 
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 Soumya Patted   Bangalore Medical College and Research Institute   Major OT complex,3 Rd floor, MPB building,Department of Anesthesiology Bangalore Medical College and Research Institute Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA 
8884839682

soumyacp121@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute   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  Normal saline   100 ml normal saline instilled once intraperitoneally through veress needle before creation of pneumoperitoneum and will stay in peritoneum till the end of surgery.This acts as control group  
Comparator Agent  Ropivacaine   Ropivacaine 3 mg/ kg body weight diluted in 100 ml normal saline instilled once intraperitoneally through veress needle before creation of pneumoperitoneum and drug will stay in peritoneum till the end of surgery. 
Intervention  Ropivacaine with dexamethasone   Ropivacaine 3 mg/kg body weight + 8 mg dexamethasone diluted in 100ml normal saline instilled intraperitoneally once through veress needle before creation of pneumoperitoneum and drug will stay in peritoneum till the end of surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients giving informed written consent
Patients age between 18 – 60 years
Patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia
Patients belonging to ASA I, II  
 
ExclusionCriteria 
Details  Patients who refused to give informed written consent.
Patients with ASA physical status III or more.
Patients posted for emergency surgeries.
Patients with history of alcohol or drug abuse.
Patients who have allergy or hypersensitivity to local anaesthetics
Pregnant or breastfeeding women.
Patients with mental illness.
Patients of renal,pulmonary, cardiovascular, hepatic, neurological, neuromuscular diseases
Patients with anticipated difficult intubation
Patients with acute cholecystitis, acute pancreatitis or peritonitis 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the pre-emptive analgesia with intraperitoneal instillation of ropivacaine with dexamethasone versus ropivacaine alone versus normal saline
 
Immediate post operative period then 1,3,6,12,24 hours in post operative period  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the hemodynamic parameters like blood pressure,heart rate, oxygen saturation etc and adverse effects with intraperitoneal instillation of ropivacaine with dexamethasone versus ropivacaine alone versus normal saline   Baseline value,after intubation, before and after port insertion then every 5 minutes for first 30 minutes later every half an hour till end of surgery.1,3,6,12,24 hours in post operative period  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   29/11/2024 
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="0"
Months="6"
Days="30" 
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   After obtaining informed written consent from patients during pre-operative visit, 60 patients will be randomly grouped by computer generated numbers and assigned to one of the three groups.Blinding will be ensured by preparing the study drugs in a ready to inject coded 50 ml syringe by the anaesthesiologist not involved with the study protocol and the postoperative follow-up of the study participant will be done by one of the anaesthesiologist blinded to the study drug administration and not involved with intraoperative management of the case.
Group A (n=20) -100 ml Normal Saline (NS)
 Group B (n=20)-3 mg/ kg of Ropivacaine in 100 ml NS
Group C (n=20)-3 mg/ kg of Ropivacaine with 8 mg dexamethasone in 100 ml NS 
All patients will be fasted for 8 hours, Inj Rantidine 50mg and Inj Metaclopramide 10 mg will be given intravenously half an hour preoperatively as pre-medication and  will be shifted to preoperative area 2 hours before the operation time and will be explained about the study and visual analogue scale (VAS) to indicate their pain perception.All standard monitors like pulse oximetry(spO2), non-invasive blood pressure (NIBP), and electrocardiogram (ECG) will be attached and baseline hemodynamic parameters will be recorded in preoperative room. Intra venous(IV) Ringer’s lactate solution will be administered as maintenance fluid (10ml/kg) through 18G peripheral venous cannula.
After preoxygenation with 100% oxygen via an anatomical face mask for 3 min, all patients will be induced with 0.2mg glycopyrrolate, lignocaine 1.0 mg/kg, fentanyl 2 µg/kg and propofol 2–2.5 mg/kg. Succinylcholine 1.5 mg/kg will be given to facilitate oral endotracheal intubation with appropriate size endotracheal tube.After checking and securing the endotracheal tube,anesthesia will be maintained with intermittent positive pressure ventilation using closed circuit and 0.5%–2% isoflourane.Muscle relaxation will be achieved with intermittent vecuronium bromide.Drug solution will be administered using veress needle before creation of pneumoperitoneum by the surgeon who did not participate in the study. During surgery, all patients will receive an IV infusion of lactated ringers solution at a rate of 5–7 ml/kg/hour and placed in 15°–20° reverse trendelenbergh’s position with left side downward tilt. During laparoscopy, intra-abdominal pressure will be limited to 10–12 mmHg and normocapnia will be ensured. The CO2 will be carefully evacuated at the end of surgery .Residual neuromuscular blockade will be reversed using injection neostigmine 0.05mg/kg and injection glycopyrollate 0.01mg/kg body weight and patient will be shifted to Post Anaesthesia Care Unit(PACU) where the anesthesiologist will be unaware of drug to which each patient is randomized. 
All patients will be assessed postoperatively in terms of following parameters:
a)Abdomen pain (immediately after recovery: 0 h, at 1, 3, 6, 12, 18, 24 h at rest and on deep breathing)
b)Shoulder tip pain (immediately after recovery: 0 h, at 1, 3, 6, 12, 18, 24 h at rest and on deep breathing)
c)Heart rate, systolic blood pressure(SBP),diastolic blood pressure(DBP), respiratory rate(RR) will be recorded at 0, 1, 3, 6, 12, 18 and 24 h
d) Time to first rescue analgesic(paracetamol)requirement and number of doses of rescue analgesics
e) Total analgesic consumption in 24 h.
f) Incidence of post operative nausea and vomiting ( PONV)
The patients with Visual Analogue Scale( VAS) score ≥4 will be administered an infusion of 1g paracetamol (IV) as rescue analgesia.Patients will be administered injection ondansetron 4 mg on complaint of nausea/vomiting. Any other adverse effects will be noted.

 
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