A Study Comparing Two Medicines, Tramadol and Tapentadol, Given Before Surgery to Reduce Pain After Gallbladder Removal

Comparison of oral Tramadol and oral Tapentadol as pre-emptive analgesic on post operative analgesia in laparoscopic cholecystectomy under general anaesthesia - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093180

Enrollment

110

Registered

2025-08-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Oral Tramadol: Oral Tramadol 100 mg, 1hr before surgery will be given pre emptively and compared with Oral Tapentadol over various timelines for post operative analgesia in laparoscopic

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA class I or II 2. Age: 18 to 70 years, either sex 3. Body mass index (BMI) of 18-35 kg/m2 4. Patients undergoing elective cholecystectomy under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. Major co-existing medical illness (especially severe asthma/COPD, repeat hernia surgery, epilepsy, uncontrolled hypertension or diabetes, liver or renal disease) 2. Patients with paralytic ileus, patients on antidepressants (to avoid risk of developing serotonin syndrome) 3. Known hypersensitivity to any of the study medications 4. Patients that had conversion to open surgery after laparoscopic visualization. 5. Known opioid abusers and patients on opioid antagonist.

Design outcomes

Primary

Measure	Time frame
1. To assess and compare the post laparoscopic cholecystectomy analgesia after use of oral Tramadol or oral Tapentadol preemptively before induction of anaesthesia. using Visual Analogue Scale (0- 10). 2. To compare the adverse effects after use of oral Tramadol or oral Tapentadol preemptively before induction of anaesthesia in patients of laparoscopic cholecystectomy. 3. Time of rescue analgesia administeredTimepoint: After shifting to PACU for postoperative pain, sedation, nausea and vomiting at 0 hour, 2 hours, 6 hours and after 24 hours post-surgery.	—

Measure

Time frame

1. To assess and compare the post laparoscopic cholecystectomy analgesia after use of oral Tramadol or oral Tapentadol preemptively before induction of anaesthesia. using Visual Analogue Scale (0- 10). 2. To compare the adverse effects after use of oral Tramadol or oral Tapentadol preemptively before induction of anaesthesia in patients of laparoscopic cholecystectomy. 3. Time of rescue analgesia administeredTimepoint: After shifting to PACU for postoperative pain, sedation, nausea and vomiting at 0 hour, 2 hours, 6 hours and after 24 hours post-surgery.

—

Secondary

Measure	Time frame
To compare the hemodynamic parameters like heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), pulse oximetry (SpO2 ) and EtCO2Timepoint: Baseline, after induction, post-intubation at 1, 5 and 10 min (T1, T5 and T10) , post-surgery when patient is shifted to PACU i.e 0 hour, 2 hours, 6 hours and after 24 hours post-surgery	—

Countries

India

Contacts

Public ContactManpreet Kaur

GMCH, Sector 32, Chandigarh

manpreetdawar@gmail.com9646121503

Outcome results

None listed

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