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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal analgesia group | Placebo Comparator | Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards. |
|
| Multimodal analgesia with preemptive pregabalin group | Experimental | Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 150mg | Drug | Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Mieszczański, MD | Contact | 669643205 | +48 | piotr.mieszczanski@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Piotr Mieszczański, MD | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szpital Kliniczny Dzieciatka Jezus | Recruiting | Warsaw | Warsaw | 02-005 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38849875 | Derived | Mieszczanski P, Gorniewski G, Janiak M, Trzebicki J. The effect of pre-emptive oral pregabalin on opioid consumption in patients undergoing laparoscopic sleeve gastrectomy with an analysis of intraoperative hemodynamic stability and quality of recovery: study protocol for a randomized, prospective, double-blind study. Trials. 2024 Jun 7;25(1):367. doi: 10.1186/s13063-024-08225-3. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | 1 capsule containing placebo per os 1 hour before start of the operation. |
|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |