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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Use, Obesity, Postoperative Pain, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Pregabalin 150mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Multimodal analgesia group<br>Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards. | Drug: Placebo<br>* 1 capsule containing placebo per os 1 hour before start of the operation.<br>|
| Experimental: Multimodal analgesia with preemptive pregabalin group<br>Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards. | Drug: Pregabalin 150mg<br>* Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative oxycodone consumption | PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes | Day 0 | 
| Postoperative pain score in NRS scale | NRS range from 0 for no pain to 10 for worst pain imaginable | Day 0, assessed 1 hour after operation | 
| Postoperative pain score in NRS scale | NRS range from 0 for no pain to 10 for worst pain imaginable | Day 0, assessed 6 hour after operation | 
| Postoperative pain score in NRS scale | NRS range from 0 for no pain to 10 for worst pain imaginable | Day 0, assessed 12 hour after operation | 
| Postoperative pain score in NRS scale | NRS range from 0 for no pain to 10 for worst pain imaginable | Day 0, assessed 24 hour after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative sedation score | 1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive | Day 0, assessed 1,6,12 and 24 hours after operation | 
| Postoperative nausea and vomiting | Simplified PONV impact scale 0-6 0 - no nausea nor vomiting 6 - >3 episodes of vomiting and nausea all of the time | Day 0, assessed 1,6,12 and 24 hours after operation | 
| Highest BP | Highest BP during operation | intraoperative | 
| Lowest BP | Lowest BP during operation | intraoperative | 
| Highest HR | Highest HR during operation | intraoperative | 
| Lowest HR | Lowest HR during operation | intraoperative | 
| Total ephedrine dosis | 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 | intraoperative | 
| Postoperative desaturation | SpO2 < 94% | Day 0, assessed 1,6,12 and 24 hours after operation | 
| Blurred vision | Presence of blurred or abnormal vision | Day 0, assessed 1,6,12 and 24 hours after operation | 
| Patient's comfort assessed in QoR-40 formulary | 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. | Day 0, assessed 24 hours after operation | 
| Postoperative oxycodone consumption | PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes | Day 0, assessed 1,6,12 and 24 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic sleeve gastrectomy, Obesity, Pregabalin, Multimodal analgesia