| CTRI Number |
CTRI/2025/03/081975 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy, Safety, and Feasibility of Opioid-Free Anaesthesia in Laparoscopic Surgeries During Peri and Post Operative Period |
|
Scientific Title of Study
|
A Prospective Randomized Double-Blinded Study to Evaluate the Efficacy, Safety, and Feasibility of Opioid-Free Anaesthesia in Laparoscopic Surgeries During the Peri and Post Operative Period |
| Trial Acronym |
EFFICACY ,SAFETY AND FEASABILITY OF OPIOID FREE ANAESTHESIA IN LAPROSCOPIC SURGERIES DURING PERI AND POST OPERATIVE PERIOD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divyalakshmi T |
| Designation |
PG resident |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College |
| Address |
Department of Anaesthesiology at Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Salem
TAMIL NADU
636308
India |
| Phone |
7397312345 |
| Fax |
914272477903 |
| Email |
sirayushidivu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divyalakshmi T |
| Designation |
PG resident |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College |
| Address |
Department of Anaesthesiology at Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Salem
TAMIL NADU
636308
India |
| Phone |
7397312345 |
| Fax |
914272477903 |
| Email |
sirayushidivu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Brindha |
| Designation |
Professor and HoD |
| Affiliation |
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem |
| Address |
Department of Anaesthesiology at Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Salem
TAMIL NADU
636308
India |
| Phone |
9443247021 |
| Fax |
914272477903 |
| Email |
mskbrins63@gmail.com |
|
|
Source of Monetary or Material Support
|
| VINAYAKA MISSIONS RESEARCH FOUNDATION |
|
|
Primary Sponsor
|
| Name |
VINAYAKA MISSIONS RESEARCH FOUNDATION |
| Address |
KIRUPANANDA VARIYAR MEDICAL COLLEGE HOSPITALS Sankari Main Road Ariyanoor Post Salem 636 308 Tamil Nadu India
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dept of Anaesthesiology |
VMK VMC&H, Salem. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divyalakshmi T |
Vinayaka Mission’s Kirupananda Variyar Medical College |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals (VMKVMC) in Salem, Tamil Nadu.
Salem
TAMIL NADU |
7397312345
sirayushidivu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE VINAYAKA MISSIONS RESEARCH FOUNDATION DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Opioid-Free Anesthesia (OFA) Protocol, which includes:
Lidocaine infusion (1.5 mg/kg)
Magnesium sulfate (2 g bolus)
Erector Spinae Plane Block (ESPB) for regional analgesia
Non-opioid analgesics:
Pre-emptive analgesia: IV Dexamethasone (8 mg) and IV Paracetamol (15 mg/kg)
Postoperative analgesia: IV Paracetamol (1 g)
General anesthesia maintenance:
Induction: IV Propofol and Vecuronium
Maintenance: Sevoflurane, Nitrous oxide, and Oxygen
Monitoring: Haemodynamic parameters, BIS (Bispectral Index) scores |
Opioid-based anesthesia using Fentanyl or Morphine for intraoperative and postoperative analgesia.
A traditional analgesic regimen including opioid administration for pain control. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants eligible for inclusion in the study must meet the following criteria:
Age Range: 18 to 60 years
ASA Classification: American Society of Anesthesiologists (ASA) Grade I and II
Elective Laparoscopic Surgery: Patients scheduled for laparoscopic cholecystectomy, appendectomy, or hernia repair
Ability to Provide Informed Consent: Patients who understand and voluntarily agree to participate in the study
Hemodynamically Stable Patients: No pre-existing severe cardiovascular instability |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the feasibility and efficacy of opioid-free anesthesia during the intraoperative period by monitoring vitals and BIS (Bispectral Index) scores.
This means the study primarily focuses on assessing how well opioid-free anesthesia maintains hemodynamic stability (heart rate, blood pressure, oxygen saturation, etc.) and the depth of anesthesia (via BIS monitoring) during surgery. |
1. Intraoperative Time Points (During Surgery)
Baseline (Before Induction)
At specific intervals after induction:
0 min
1 min
5 min
10 min
15 min
30 min
45 min
60 min
75 min
90 min
105 min
120 min
135 min
150 min
2. Postoperative Time Points (After Surgery)
Immediately after extubation
Follow-up monitoring at:
0 hours (immediate post-op)
15 minutes
30 minutes
1 hour
2 hours
4 hours
8 hours
12 hours
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome measures include postoperative pain assessment, time to first analgesic request, total postoperative analgesic consumption, incidence of postoperative adverse effects, and postoperative recovery parameters. Pain will be assessed using the Visual Analog Scale (VAS) at multiple time points. The total dose of rescue analgesia required within the first 24 hours will be recorded. Adverse effects such as nausea, vomiting, sedation, and respiratory depression will be monitored. Recovery parameters, including time to ambulation and time to discharge from PACU, will also be evaluated |
Postoperative pain (VAS score) will be measured at 0, 15, and 30 minutes, and at 1, 2, 4, 6, 8, 12, and 24 hours. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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 Yet Recruiting |
| 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
|
This prospective, randomized, double-blinded study aims to evaluate the efficacy, safety, and feasibility of Opioid-Free Anaesthesia (OFA) in laparoscopic surgeries. The study will compare OFA, which includes Lidocaine, Magnesium, and Erector Spinae Plane Block (ESPB), with Standard Opioid-Based Anaesthesia (SOBA) using conventional opioids. The primary outcome measures include hemodynamic stability, BIS scores, and intraoperative analgesic requirements. Secondary outcomes focus on postoperative pain (VAS scores), time to first analgesic request, total postoperative analgesic consumption, incidence of adverse effects, and recovery parameters. A total of 100 adult patients will be recruited and followed for 24 hours postoperatively. The study aims to determine whether OFA can provide effective perioperative pain management while reducing opioid-related side effects. |