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To compare the efficacy of pain control with use of opioids vs not use of opioids in post-operative period in patients undergoing open thoracotomy surgeries

To compare the efficacy of opioid free anaesthesia with opioid based anaesthesia on post-operative opioid consumption in patients undergoing open thoracotomy surgeries: a prospective randomized control trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037457
Enrollment
50
Registered
2021-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Opioid free anaesthesia: Any form of opioid will not be used during the anaesthesia, instead of opioids other alternative drugs will be used i.e. ini dexmedetomidine, injection ketamine

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA status I-III 2. Undergoing elective thoracotomy for lung cancer under anaesthesia

Exclusion criteria

Exclusion criteria: 1. Infection at the site of injection for epidural anaesthesia 2. Coagulopathy 3. Spine deformity 4. Pre-existing neurological deficit 5. Patients with a history of chronic pain 6. Patients on opioids preoperatively 7. Drug addicts 8. History of allergy to opioids or local anaesthetic 9. Patients with psychiatric disease 10. Uncontrolled systemic illness (liver disease, cardiac disease, renal failure) 11. Contraindications of epidural anaesthesia 12. Inability to use IV patient controlled analgesia (PCA) 13. Patients requiring postoperative mechanical ventilation

Design outcomes

Primary

MeasureTime frame
Post-operative 24 hrs IV fentanyl consumptionTimepoint: 24 hrs—

Secondary

MeasureTime frame
Oxygenation index (PaO2/FiO2) during two lung ventilation and OLVTimepoint: during two lung ventilation (before initiation of OLV and after end of OLV) and OLV (at 30 min and 60min after initiation of OLV);Pain assessment using NRS during cough/deep breathing at postoperative timeTimepoint: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, and 24 hrs post-operative period.;Pain assessment using Numerical rating scale (NRS) at restTimepoint: 1 hr, 2 hrs, 4hrs, 8hrs, 12 hrs, and 24hrs postoperative period.;Patients satisfaction scoreTimepoint: on postoperative day 1;Post-operative complications like nausea vomiting, pruritis etcTimepoint: 24hrs post operative period;Postoperative sedationTimepoint: 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, and 24 hrs postoperative period.—

Countries

India

Contacts

Public ContactDr Pratishtha Yadav

DR. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical sciences

vkchanpadia@gmail.com9674465181

Outcome results

None listed

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