| 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
|
|
|
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
|
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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 |
|
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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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