Comparison of the Effect of General Anesthesia with Opioids vs Opioid Free Anesthesia on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy

Evaluate of postoperative pain both with and without Opioid general anesthesia technique in Laparoscopic Cholecystectomy

In this study, 160 patients who were nominated for non-emergency Laparoscopic Cholecystectomy and who entered the study are referred to Kashan Shahid Beheshti Hospital. Participants are randomly divided into intervention and control groups and assigned a code to hide the intervention group of each participant.

This study is performed in the Department of Surgery of Shahid Beheshti Hospital of Kashan. Select the person code in each group is done by the Statistical Consultant, and Inclusion criteria and Exclusion criteria and the allocation of each patient according to the entry code are made by the Anesthetist's Assistant, but the anesthetist's process is conducted by the Senior Anesthetist Assistant. The persons evaluating the patient are different during surgery in Operating room, in the Recovery room, and in the Post-Surgical Department, and from the chosen anesthetic method for each patient are unaware, By doing this, Two-way blinding is provided in the study.

Age 18 - 65 years old, candidate for non-emergency Laparoscopic Cholecystectomy, ASA Class 1, 2. Exclusion criteria: Usage of Opioid Drugs within 24 hours before of surgery, Allergy to any medication used in the study, Motion Sickness, Addiction, Cardiac Disease, Hypertention, History of Sleep Apnea, Gastrointestinal Bleeding, Parkinson's disease, Liver and Kidney Diseases, Emergency Surgery, Pregnancy and BMI> 35.

The first group will get Opioid-Free Anesthesia. Ketorolac, Ketamine , Lidocaine and Paracetamol will be used as an alternatives of Opioid.The second group, fentanyl and Remifentanil will be used. In both groups, hemodynamic changes are controlled with Nitroglycerin, Labetalol, Ephedrine and Atropine. Periodically, Meperidine, Paracetamol, Metoclopramide and Ondansetron will be prescribed if needed. BIS is maintained in the range of 40 to 60 during the anesthesia.The Mepridine and Paracetamol medications and Metoclopramide and Ondansetron are prescribed at intervals if needed.

Pain intensity and Nausea after surgery is measured by 11-item Visual Analog Scale.

Kashan University of Medical Sciences

After referral of patients for elective Laparoscopic Cholecystectomy and evaluation of inclusion criteria and removal of patients who have exit criteria, they are divided into 2 groups using randomized block assignment (Permuted block randomization). The first group received an Opioid free anesthesia and the second group received a routine anesthesia (with Opioid).

After admitting the patients, the Anesthetist's Assistant assesses them in terms of Inclusion Criteria and Exclusion Criteria., and then the Volunteers are selected from among them, and after obtaining Informed Written Consent from them, they are enrolled in the study without knowing the group in which they are placed. The Code assigned to each participant will be the order of Admission time. The position of each Code in the two groups is determined by the Statistics Consultant (Before commencing the admission of patients). The Anesthetic process is performed by the Senior Assistant and the Researcher does not play a direct role in the anesthetic process. Patient evaluators are different in the Operating Room and Recovery Room and Post-Surgical Ward, and are unaware of the anesthetic method. By doing this, Double-blind study method is provided.