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Study Comparing Two medicine for Pain Relief After Open Gallbladder Surgery

Comparison of postoperative analgesia between intramuscular tramadol vs intranasal tapentadol following open cholecystectomy: An open label randomized clinical triaL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104309
Enrollment
150
Registered
2026-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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: intranasal tapentadol 45 mg that is 22.5 mg in each nostril thrice daily for 72 hours. Control Intervention1: intramuscular tramadol: intramuscular tramadol 100 m

Sponsors

PRAJNAPARMITA SAHA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the newly diagnosed Cholecystitis patients undergoing Open Cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification 1 & 2 at General Surgery Department of AGMC, in the age group of 18 years and above, shall be included in the study.

Exclusion criteria

Exclusion criteria: Patients with ASA class 3 or above status. - Patients below 18 years of age - Patients on immunosuppressive drugs. - Patients unwilling for giving consent. - Pregnant and lactating women. - Subjects with Chronic Kidney Disease

Design outcomes

Primary

MeasureTime frame
determine and compare the degree of analgesia of intramuscular Tramadol and intranasal Tapentadol in post operative pain management following Open Cholecystectomy. Timepoint: determine and compare the degree of analgesia of intramuscular Tramadol and intranasal Tapentadol in post operative pain management following Open Cholecystectomy 2 hours after each dose for 72 hours by visual analouge score

Secondary

MeasureTime frame
to demonstrate any adverse event by the drugs used.Timepoint: assessment will be done after 2 hours of each dose for 72 hours.

Countries

India

Contacts

Public ContactPRAJNAPARMITA SAHA

AGARTALA GOVERNMENT MEDICAL COLLAGE

prajnaparmitas@gmail.com7085826059

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026