COMPARISON OF THE EFFICACY OF OPIOID-FREE ANESTHESIA AND OPIOID-BASED ANESTHESIA IN FEMALE LAPAROSCOPIC STERILIZATION

Comparison of the Efficacy of Opioid-Free Anaesthesia and Opioid-Based Anaesthesia in Gynecological Laparoscopic Sterilization Under ERAS Protocol : A Randomized Controlled Trial - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086261

Enrollment

Registered

2025-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: Z302- Encounter for sterilization

Interventions

Intervention1: Opioid-Free Anesthesia: For the Opioid-Free Anaesthesia (OFA) Group, Midazolam at 0.05mg/kg iv will be given 1 min prior to induction along with IV doses of dexamethasone 8mg, Ketorolac

Eligibility

Inclusion criteria

Inclusion criteria: 1.Scheduled for elective gynecological laparoscopic sterilisation. 2.Able to provide informed consent. 3.ASA grade I or II. 4.Hemodynamically stable with no acute medical illness requiring urgent intervention. 5.Not pregnant or breastfeeding. 6.No known allergies to study medications. 7.Willing to comply with study procedures and follow-up assessments.

Exclusion criteria

Exclusion criteria: 1.Emergency surgeries or surgeries requiring conversion to open procedures. 2.ASA physical status above II. 3.History of significant cardiac, hepatic, renal, or respiratory disease. 4.Known allergy or contraindication to study medications. 5.Chronic opioid use or dependence. 6.Pregnancy or breastfeeding 7.Inability to provide informed consent. 8.Any condition deemed by the investigator to pose a risk to the patient or interfere with the study procedures. 9.Duration of surgery more than 30 min.

Design outcomes

Primary

Measure	Time frame
Postoperative Pain Control and Recovery OutcomesTimepoint: Preoperative (baseline assessment) Intraoperative (during surgery) Postoperative: a. Immediate postoperative period (e.g., recovery room) b. 24 hours postoperative	—

Secondary

Measure	Time frame
1. Postoperative pain scores and analgesic requirements in first 24 hours post-surgery 2. Intraoperative hemodynamic stability during surgery 3. Patient satisfaction with the anesthetic technique post-surgery 4. Quality of recovery (QoR) using the QoR-15 questionnaire Post-surgeryTimepoint: Postoperative pain scores and analgesic requirements: within 24 hours post-surgery Intraoperative hemodynamic stability: During surgery Patient satisfaction with the anesthetic technique: Post-surgery Quality of recovery (QoR) using the QoR-15 questionnaire: Post 24 hours after surgery	—

Measure

Time frame

1. Postoperative pain scores and analgesic requirements in first 24 hours post-surgery 2. Intraoperative hemodynamic stability during surgery 3. Patient satisfaction with the anesthetic technique post-surgery 4. Quality of recovery (QoR) using the QoR-15 questionnaire Post-surgeryTimepoint: Postoperative pain scores and analgesic requirements: within 24 hours post-surgery Intraoperative hemodynamic stability: During surgery Patient satisfaction with the anesthetic technique: Post-surgery Quality of recovery (QoR) using the QoR-15 questionnaire: Post 24 hours after surgery

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Countries

India

Contacts

Public ContactDrManjit Singh Kanwar

Dr.Radhakrishnan Government Medical College

drmanjitkanwar@gmail.com8219500838

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026