A comparative study between intravenous Tramadol vs intranasal Tapentadol on postoperative analgesia in laparoscopic cholecystectomy.

Acute postoperative pain that is not adequately treated may lead to long-term morbidity. This 

has been the focus of several pharmacotherapies. Considering medication-related adverse

effects, we wish to compare intravenous (IV) tramadol and intranasal tapentadol in postoperative analgesia following laparoscopic surgery. We evaluated intranasal tapentadol’s

involvement in post-operative analgesia and its dosage required following laparoscopic

cholecystectomy, taking into account its improved tolerability profile.

OBJECTIVE:

Primary objective:

The primary objective of our study is to compare postoperative pain severity using visual

analogue scale (VAS) grading with intranasal tapentadol versus intravenous tramadol in

patients undergoing elective laparoscopic cholecystectomy under general anaesthesia and

when the first rescue analgesia given (duration of analgesia).

Secondary objectives:

a. The number of times rescue analgesics are administered in the postoperative period.

b. Postoperative nausea, vomiting, sedation, and other adverse effects of intranasal

tapentadol versus intravenous tramadol in patients undergoing elective laparoscopic

cholecystectomy under general anaesthesia.

METHODOLOGY:

Following ethical approval and informed consent, 72 ASA I-II patients aged 18-60 yrs

scheduled for elective laparoscopic cholecystectomy will be included. They will be separated

into two groups: Group T will get IV tramadol (1 mg/kg), whereas Group P will receive

intranasal tapentadol (45 mg) 30 minutes before extubation. Fentanyl, propofol, atracurium,

glycopyrrolate, midazolam, paracetamol and ondansetron will be used as per standard

general anaesthesia protocol. Routine post operative analgesia will be provided with infusion

paracetamol 1 gm IV 12 hourly. The Visual Analogue Scale (VAS) and Ramsay Sedation

Score (RSS) will evaluate post-operative pain and sedation at 0, ½, 1, 2, 4, 6, and 12 hours,

respectively. As rescue analgesic injection diclofenac sodium 75 mg IM will be given. Rescue

analgesic use, adverse effects will all be reported and statistically analysed.

EXPECTED OUTCOME:

A) Because of its rapid mucosal absorption, intranasal tapentadol is likely to provide faster

onset of analgesia than IV tramadol.

B) Patients taking intranasal tapentadol may have lower VAS scores, longer durations of

analgesia, and a lower dose of rescue analgesics.

C) Tapentadol is believed to have less adverse effects (such as nausea, vomiting, and

drowsiness), making it more tolerable. Overall, intra nasal tapentadol may prove to be a more

patient-friendly and efficient alternative to intravenous tramadol for postoperative analgesia in

laparoscopic cholecystectomy.