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Comparison of Two Methods of Pain Management After Laparoscopic Surgery: Intranasal Tapentadol vs Fentanyl Patch

A Comparative Study of Intranasal Tapentadol with transdermal fentanyl patch for postoperative analgesia in laparoscopic surgeries. A Randomized triple blinded study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099120
Enrollment
144
Registered
2025-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: K819- Cholecystitis, unspecified

Interventions

Intervention1: Intranasal Tapentadol spray in patients undergoing laparoscopic surgeries: patients will have a placebo patch placed 14 hours before the surgery and will receive Intranasal Tapentadol s

Sponsors

All india institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status 1 and 2 Patients undergoing elective laparoscopic surgeries under general anaesthesia

Exclusion criteria

Exclusion criteria: Patient refusal to participate Emergency surgeries ASA physical status 3 and 4 Patients unable to cooperate or follow instructions Complex surgeries which require drain Patients with contraindications to general anaesthesia Patients with risk of opioid addiction Surgery lasting more than 6 hours Cases requiring intraoperative conversion from laparoscopic to open surgery

Design outcomes

Primary

MeasureTime frame
Static VAS score Dynamic VAS score Timepoint: 15 mins 30 mins 45 mins 6 hours 12 hours 18 hours 24 hours

Secondary

MeasureTime frame
Time & frequency of rescue analgesia. Total dose of rescue analgesia. Postoperative Ramsay sedation score. Intraoperative hemodynamic variations. Side effects such as Nausea, vomiting, itching. Timepoint: 15 mins 30 mins 6 hours 12 hours 18 hours 24 hours

Countries

India

Contacts

Public ContactDr Kalyani Surya Dhana Lakshmi

All india institute of Medical Sciences

sksdhanalakshmi@gmail.com7893720606

Outcome results

None listed

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