Obesity, Opioid Use, Postoperative Nausea and Vomiting, Postoperative Pain
Conditions
Keywords
Laparoscopic sleeve gastrectomy, Obesity, Pregabalin, Multimodal analgesia
Brief summary
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
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.
Interventions
DRUGPregabalin 150mg
Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.
DRUGPlacebo
1 capsule containing placebo per os 1 hour before start of the operation.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative oxycodone consumption | Day 0 | PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes |
| Postoperative pain score in NRS scale | Day 0, assessed 1 hour after operation | NRS range from 0 for no pain to 10 for worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative sedation score | Day 0, assessed 1,6,12 and 24 hours after operation | 1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive |
| Postoperative nausea and vomiting | Day 0, assessed 1,6,12 and 24 hours after operation | Simplified PONV impact scale 0-6 0 - no nausea nor vomiting 6 - \>3 episodes of vomiting and nausea all of the time |
| Highest BP | intraoperative | Highest BP during operation |
| Lowest BP | intraoperative | Lowest BP during operation |
| Highest HR | intraoperative | Highest HR during operation |
| Lowest HR | intraoperative | Lowest HR during operation |
| Total ephedrine dosis | intraoperative | 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 |
| Postoperative desaturation | Day 0, assessed 1,6,12 and 24 hours after operation | SpO2 \< 94% |
| Blurred vision | Day 0, assessed 1,6,12 and 24 hours after operation | Presence of blurred or abnormal vision |
| Patient's comfort assessed in QoR-40 formulary | Day 0, assessed 24 hours after operation | 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. |
| Postoperative oxycodone consumption | Day 0, assessed 1,6,12 and 24 hours after operation | PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes |
Countries
Poland
Contacts
Primary ContactPiotr Mieszczański, MD
Outcome results
None listed