| CTRI Number |
CTRI/2023/08/056874 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
20/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post-operative pain relief in laparoscopic cholecystectomy, comparison between Opioid-free anaesthesia vs Opioid anaesthesia |
|
Scientific Title of Study
|
Post-operative pain relief in laparoscopic cholecystectomy, comparison between Opioid-free anaesthesia using injection Dexmedetomidine infusion and injection Lidocaine bolus vs Opioid anaesthesia using injection Fentanyl: A Randomized Controlled 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 |
Akash Markande |
| Designation |
DNB Anesthesia trainee |
| Affiliation |
Northern railway central hospital , new delhi |
| Address |
department of anesthesiology ward 4 northern railway central hospital, new delhi 110055
department of anesthesiology ward 4 northern railway central hospital, new delhi 110055
New Delhi
DELHI
110055
India |
| Phone |
7972023641 |
| Fax |
|
| Email |
akashmarkande9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta chadha |
| Designation |
Additional chief health director |
| Affiliation |
Northern railway central hospital |
| Address |
Head of department, department of anesthesiology ward 4 northern railway central hospital, new delhi 110055
New Delhi
DELHI
110055
India |
| Phone |
9717630526 |
| Fax |
|
| Email |
mamtachadha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta chadha |
| Designation |
Additional chief health director |
| Affiliation |
Northern railway central hospital |
| Address |
Head of department, department of anesthesiology ward 4 northern railway central hospital, new delhi 110055
New Delhi
DELHI
110055
India |
| Phone |
9717630526 |
| Fax |
|
| Email |
mamtachadha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Northern railway central hospital , new delhi |
|
|
Primary Sponsor
|
| Name |
Northern railway central hospital |
| Address |
Northern railway central hospital , basant lane, new delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akash markande |
Northern railway central hospital |
Ward no 4, Department of Anaesthesiology Northern railway central hospital ,basant lane , new delhi 110055
New Delhi
DELHI |
7972023641
akashmarkande9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-NRCH institutional ethics committee noerthern railway central hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
opioid analgesia using inj fentanyl |
opioid analgesia inj Fentanyl 0.5 mcg/kg in 10 ml dilution with normal saline at induction followed by maintenance dose Inj fentanyl 0.5 mcg/kg in bolus dose when there is increase in intra-operative blood pressure and 50 ml normal saline infusion till gall bladder extract out |
| Intervention |
Opioid free analgesia using inj dexmedetomidine infusion and inj lidocaine bolus |
Opioid free analgesia using inj. dexmedetomidine infusion at 0.7mcg/kg loading dose over 10 min in 10 ml followed by 0.5 mcg/kg maintenance dose in 50 ml and inj lidocaine bolus 1.5 mg/kg before port insertion till gall bladder extract out |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients coming for laparoscopic cholecystectomy surgery of American Society of Anesthesiologists Grade I-II patients |
|
| ExclusionCriteria |
| Details |
1.BMI: 35 and above
2.Second degree Heart block and above
3.Bradycardia and hypotension
4.Diabetes
5.Psychiatric disease
6.History of chronic pain
7.Alcohol or drug abuse
8.Allergy to any of a drug in the study groups
9.Pregnant, breast-feeding or menstruating women
10.Any analgesic or antiemetic use in last 24 hours before anaesthesia induction
|
|
|
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 pain relief in post operative period using visual analogue scale for 24 hour during rest at 0, 2, 4, 6, 12, 24 hours & at movement (coughing & lateral decubitus position )at 6, 12, 24 hours |
24 hours post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of intra-operative hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure & mean arterial pressure) between 2 groups at just before induction & at 5, 15, 30, 60 min after induction for all patients.
2. Compare total rescue analgesic requirements between 2 groups in first 24 hours.( rescue non-opioid analgesic Inj. Diclofenac 75mg will be given If VAS more than 4, those patients with persistent severe pain [VAS more than 8-10],opioid analgesia in form of Inj. Tramadol 50 mg.)
3. Postoperative nausea & vomiting will be noted and graded according to standard PONV scoring system.
|
intraoperative hemodynamic before induction & at 5, 15, 30, 60 min after induction for all patients. |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/09/2023 |
| 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="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The aim of this study to compare pain relief between opioid free analgesia group and opioid group posted for laparoscopic cholecystectomy for gall stone . subjects and outcome assessor are blinded to type of group ,patients age between 18 to 70 years with cholelithiasis scheduled for surgery will be assessed for eligibility to participate in study . patients with ASA > III allergy to drugs used in trial are excluded .during surgery intraoperative parameters (HR, BP ) between 2 groups noted before induction and at 5, 15, 30, 60 min after induction for all patients subjects will receive either opioid analgesia or opioid free analgesia after randomization .monitor throughout surgery . after surgery patients will be monitored in PACU for pain relief using Visual analogue scale at 2,4,6,12,24 hr at rest and 6,12,24 hr at movements . inadeqate pain relief VAS more than 4 non opioid based analgesia inj diclofenac sodium 75 mg and VAS more than 8 opioid based analgesia inj Tramadol 50 mg will be administered . for 24 hr post operative period pain will be assessed .and post operative nausea vomiting will be noted treated with antiemetic . |