Efficacy, Safety, and Feasibility of Opioid-Free Anaesthesia in Laparoscopic Surgeries During Peri and Post Operative Period

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 - EFFICACY ,SAFETY AND FEASABILITY OF OPIOID FREE ANAESTHESIA IN LAPROSCOPIC SURGERIES DURING PERI AND POST OPERATIVE PERIOD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081975

Enrollment

100

Registered

2025-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: 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 a

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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	—

Measure

Time frame

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.Timepoint: 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

Measure	Time frame
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 evaluatedTimepoint: Postoperative pain (VAS score) will be measured at 0, 15, and 30 minutes, and at 1, 2, 4, 6, 8, 12, and 24 hours.	—

Measure

Time frame

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 evaluatedTimepoint: Postoperative pain (VAS score) will be measured at 0, 15, and 30 minutes, and at 1, 2, 4, 6, 8, 12, and 24 hours.

—

Countries

India

Contacts

Public ContactDr R Brindha

Vinayaka Missions Kirupananda Variyar Medical College

sirayushidivu@gmail.com7397312345

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026