To compare analgesic effect of opioid free anaesthesia vs opioid based anaesthesia in lumbar spine fixation surgery

A Randomized Comparative Study to Evaluate Analgesic Efficacy of Opioid-Free Anesthesia Vs Opioid-Based Anesthesia in Patients Undergoing Lumbar Spine Fixation Surgery at SMS Medical College and Hospital Jaipur - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110596

Enrollment

Registered

2026-05-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Opioid free anaesthesia: Patients will receive analgesic

Ketamine 1mg/kg bolus over 10-20seconds Followed by Induction with propofol 2 mg/ kg till the loss of verbal response , ketofol will be infused at a rate of 0.3 0.6 ml/kg/hr, and the drug infusion rat

fentanyl 2mcg/kg over bolus over 10-20 sec Followed by induction with propofol 2 mg/ kg till the loss of verbal response, propofol will be infused at a rate of 0.3 0.6 ml/kg/hr, and the drug infusion

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing lumbar spine surgery. 2.Patient with informed written consent. 3.Patient of age 18-60 years. 4.Patient of either gender. 5.Patient of weight 40 to 60kg. 6.Patient belonging to ASA class I and II

Exclusion criteria

Exclusion criteria: 1. Patients not participating in study. 2. Allergy to study drugs. 3. Psychiatric patients. 4. Severe pain scores more than 8 before surgery. 5. Sensory or motor deficit prior to surgery

Design outcomes

Primary

Measure	Time frame
To assess and compare the analgesic characteristics (time to first request for rescue analgesia, the total rescue analgesia consumption, and the Numeric Rating Scale (NRS) pain scores) in the postoperative period between patient receiving opioid- free anesthesia vs opioid based anesthesia.Timepoint: At 0 hr , 6 hr , 12 hr , 24 hr postoperatively	—

Secondary

Measure	Time frame
1. To assess & compare hemodynamic parameters in intraoperative period between patient receiving opioid-free anesthesia vs opioid-based anesthesia. 2. To assess & compare proportion of patients experiencing side effect between the patient receiving opioid-free anesthesia vs opioid based anesthesia.Timepoint: Hemodynamic monitoring at baseline, before induction, after induction, after prone position, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105min, 120 min.	—

Measure

Time frame

1. To assess & compare hemodynamic parameters in intraoperative period between patient receiving opioid-free anesthesia vs opioid-based anesthesia. 2. To assess & compare proportion of patients experiencing side effect between the patient receiving opioid-free anesthesia vs opioid based anesthesia.Timepoint: Hemodynamic monitoring at baseline, before induction, after induction, after prone position, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105min, 120 min.

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Countries

India

Contacts

Public ContactDr Arpita Lahoti

SMS medical college and attached hospital jaipur

drneelu13@gmail.com9782480455

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026