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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.
1 capsule containing placebo per os 1 hour before start of the operation.
Szpital Kliniczny Dzieciatka Jezus
Warsaw, Warsaw, Poland
RECRUITINGTotal 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
Time frame: Day "0"
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day "0", assessed 24 hour after operation
Postoperative sedation score
1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive
Time frame: 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
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Highest BP
Highest BP during operation
Time frame: intraoperative
Lowest BP
Lowest BP during operation
Time frame: intraoperative
Highest HR
Highest HR during operation
Time frame: intraoperative
Lowest HR
Lowest HR during operation
Time frame: 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
Time frame: intraoperative
Postoperative desaturation
SpO2 \< 94%
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Blurred vision
Presence of blurred or abnormal vision
Time frame: 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.
Time frame: 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
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
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