Pregabalin in the Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (LSG).

The Effect of Preemptive Oral Pregabalin as an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. A Randomized, Prospective, Double Blind Study.

The aim of this clinical trial is to assess preemptive oral pregabalin administration in the obese patients undergoing laparoscopic sleeve gastrectomy. The main aims of the study are to evaluate postoperative pain treatment and effect on the intraoperative hemodynamical stability. The participants will be divided into 2 groups: with or without preemptive pregabalin administration.

Pregabalin is a GABA analogue that has analgesic, anxiolytic and effects. There are studies indicating that this drug can be used as an element of multimodal analgesia to decrease opioid requirements in postoperative period. Such an effect would be particularly beneficial for patients with obesity scheduled for laparoscopic sleeve gastrectomy, most commonly performed bariatric surgery. The investigators hypothesized that preemptive pregabalin administration may improve quality of postoperative pain score with less incidence of opioid side effects as well as similar or better intraoperative hemodynamical stability.

Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.

Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.

PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes

Simplified PONV impact scale 0-6 0 - no nausea nor vomiting 6 - >3 episodes of vomiting and nausea all of the time

Ephedrine is a vasopressor used in case of hypotension to maintain mean arterial pressure > 65 mmHg or to increase blood pressure to check surgical hemostasis

QoR-40 (Quality of Recovery) scale is used to measure the quality of recovery after surgery and anesthesia, it is a 40 item questionnaire that provides a score across five dimensions: patient support, comfort, emotions, physical independence, and pain. Formulary will assess first 24 hours following the operation. Maximal score is 200, higher result is associated with better quality of recovery.

PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes

Inclusion Criteria: Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities Written informed consent Exclusion Criteria: Patient's refusal Known allergies to study medication Inability to comprehend or participate In pain scoring scale Inability to use intravenous patient controlled analgesia Changes of operation extent during procedure Revisional operations End stage organ failure