To compare the drug tapendatol (opioid) through nose with Transversus Abdomens Plane block(injection in the abdomen) and local site injection in patients undergoing laparoscopic cholecystectomy.

Comparison of Tapentadol nasal spray with Tranversus abdominis plane block and port site infiltration in patients undergoing laparoscopic surgeries for post operative pain management: A Randomized controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/074451

Enrollment

120

Registered

2024-09-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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: Tapendatol nasal spray: Group III will receive tapentadol nasal spray 22.5 mg in each nostril total 45 mg after the extubation. Control Intervention1: Portsite: Group I will be the port

Eligibility

Inclusion criteria

Inclusion criteria: Males or females aged 18-65 years undergoing laparoscopic surgery

Exclusion criteria

Exclusion criteria: 1. Patients with history of allergy to local anesthetics, tapentadol 2. Patients who are receiving MAO inhibitors or have taken them in last 14 days. 3. Hemodynamically unstable patients 4. Coagulopathy 5. Significant liver or renal disease 6. Diagnosis of chronic pain syndrome

Design outcomes

Primary

Measure	Time frame
To compare the VAS score of tapentadol nasal spray, TAP block and port site infiltration in providing post-operative pain relief in laparoscopic surgeriesTimepoint: 0,1,2,3,6,12,24 hr	—

Secondary

Measure	Time frame
To compare the time for first rescue analgesiaTimepoint: 0,1,2,3,6,12,24 hr;To compare the total dose of rescue analgesia of rescue analgesia demanded in first 24 hoursTimepoint: 0,1,2,3,6,12,24 hr;To compare the incidence of nausea & vomitingTimepoint: 0,1,2,3,6,12,24 hr;To compare any other side effectTimepoint: 0,1,2,3,6,12,24 hr	—

Countries

India

Contacts

Public ContactDr Ravneet Kaur Gill

Dr B R Ambedkar State Institute of Medical Sciences

drravneetkgill@gmail.com9501988361

Outcome results

None listed

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