To Compare role of Oral Tapentadol vs Pregabalin as a pre-emptive analgesia in Laproscopic Cholecystectomy under General Anaesthesia

Comparison of Oral Tapentadol vs Pregabalin as a pre-emptive analgesia in Laproscopic Cholecystectomy under General Anaesthesia - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112747

Enrollment

120

Registered

2026-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: K81- Cholecystitis Health Condition 2: K80- Cholelithiasis

Interventions

Intervention1: ORAL PREGABALIN: The study population is divided into 2 groups of 60 patients each.Group P consists of 60 pateints receiving oral pregabalin. Control Intervention1: ORAL TAPENTADOL: The

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients capable of providing an informed consent. 2.Patient of any gender between age group between 18-60 years scheduled for elective laparoscopic cholecystectomy under general anaesthesia 3.BMI ranging between 20-30kg per m2 4.Duration of surgery upto 2hrs

Exclusion criteria

Exclusion criteria: 1.Patients with asthma, COPD or any other respiratory disease, chronic pain, carcinoma, liver disease, renal disease, pregnant or lactating mother, cardiovascular insufficiency, Patient with known neurological or neuropsychiatric disorders or Epilepsy etc. 2.Patients undergoing treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re-uptake inhibitors, gabapentinoids. 3.Drug or alcohol abuse history and opioid dependence. 4.Known history of opioid allergy or pregabalin allergy.

Design outcomes

Secondary

Measure	Time frame
To compare sedation score by Ramsay sedation scale Determine the time to first administration of rescue analgesia & to estimate total dose of rescue analgesia in 24 hours. To evaluate postoperative nausea, vomiting by using Likert scale & other adverse effects such as respiratory depression. Timepoint: At time of extubation,at 30 minutes,60 mins,90 mins,120 mins,6 hrs,12 hrs,18 hrs & 24 hrs	—

Primary

Measure	Time frame
To compare postoperative visual analogue scale (VAS) score.Timepoint: At time of extubation,at 30 minutes,60 mins,90 mins,120 mins,6 hrs,12 hrs,18 hrs and 24 hrs	—

Countries

India

Contacts

Public ContactDr Ajay Kumar Sinha

GMC Haldwani

sinhaak1961@gmail.com9412906901

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026