A comparative study to evaluate the pre-emptive analgesia by intra peritoneal instillation of Ropivacaine with dexamethasone versus Ropivacaine alone versus Normal saline in patients undergoing laparoscopic cholecystectomy – A Randomized clinical trial

After obtaining informed written consent from patients during pre-operative visit, 60 patients will be randomly grouped by computer generated numbers and assigned to one of the three groups.Blinding will be ensured by preparing the study drugs in a ready to inject coded 50 ml syringe by the anaesthesiologist not involved with the study protocol and the postoperative follow-up of the study participant will be done by one of the anaesthesiologist blinded to the study drug administration and not involved with intraoperative management of the case.

Group A (n=20) -100 ml Normal Saline (NS)

Group B (n=20)-3 mg/ kg of Ropivacaine in 100 ml NS

Group C (n=20)-3 mg/ kg of Ropivacaine with 8 mg dexamethasone in 100 ml NS

All patients will be fasted for 8 hours, Inj Rantidine 50mg and Inj Metaclopramide 10 mg will be given intravenously half an hour preoperatively as pre-medication and  will be shifted to preoperative area 2 hours before the operation time and will be explained about the study and visual analogue scale (VAS) to indicate their pain perception.All standard monitors like pulse oximetry(spO2), non-invasive blood pressure (NIBP), and electrocardiogram (ECG) will be attached and baseline hemodynamic parameters will be recorded in preoperative room. Intra venous(IV) Ringer’s lactate solution will be administered as maintenance fluid (10ml/kg) through 18G peripheral venous cannula.

After preoxygenation with 100% oxygen via an anatomical face mask for 3 min, all patients will be induced with 0.2mg glycopyrrolate, lignocaine 1.0 mg/kg, fentanyl 2 µg/kg and propofol 2–2.5 mg/kg. Succinylcholine 1.5 mg/kg will be given to facilitate oral endotracheal intubation with appropriate size endotracheal tube.After checking and securing the endotracheal tube,anesthesia will be maintained with intermittent positive pressure ventilation using closed circuit and 0.5%–2% isoflourane.Muscle relaxation will be achieved with intermittent vecuronium bromide.Drug solution will be administered using veress needle before creation of pneumoperitoneum by the surgeon who did not participate in the study. During surgery, all patients will receive an IV infusion of lactated ringers solution at a rate of 5–7 ml/kg/hour and placed in 15°–20° reverse trendelenbergh’s position with left side downward tilt. During laparoscopy, intra-abdominal pressure will be limited to 10–12 mmHg and normocapnia will be ensured. The CO2 will be carefully evacuated at the end of surgery .Residual neuromuscular blockade will be reversed using injection neostigmine 0.05mg/kg and injection glycopyrollate 0.01mg/kg body weight and patient will be shifted to Post Anaesthesia Care Unit(PACU) where the anesthesiologist will be unaware of drug to which each patient is randomized.

All patients will be assessed postoperatively in terms of following parameters:

a)Abdomen pain (immediately after recovery: 0 h, at 1, 3, 6, 12, 18, 24 h at rest and on deep breathing)

b)Shoulder tip pain (immediately after recovery: 0 h, at 1, 3, 6, 12, 18, 24 h at rest and on deep breathing)

c)Heart rate, systolic blood pressure(SBP),diastolic blood pressure(DBP), respiratory rate(RR) will be recorded at 0, 1, 3, 6, 12, 18 and 24 h

d) Time to first rescue analgesic(paracetamol)requirement and number of doses of rescue analgesics

e) Total analgesic consumption in 24 h.

f) Incidence of post operative nausea and vomiting ( PONV)

The patients with Visual Analogue Scale( VAS) score ≥4 will be administered an infusion of 1g paracetamol (IV) as rescue analgesia.Patients will be administered injection ondansetron 4 mg on complaint of nausea/vomiting. Any other adverse effects will be noted.