Clinical trial NCT05804591: Pregabalin in the Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (LSG).
Official title: The Effect of Preemptive Oral Pregabalin As an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. a Randomized, Prospective, Double Blind Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obesity
Postoperative Pain
Postoperative Nausea and Vomiting
Opioid Use
Keywords: Laparoscopic sleeve gastrectomy
Obesity
Pregabalin
Multimodal analgesia
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total postoperative oxycodone consumption
timeFrame: Day "0"
measure: Postoperative pain score in NRS scale
timeFrame: Day "0", assessed 1 hour after operation
measure: Postoperative pain score in NRS scale
timeFrame: Day "0", assessed 6 hour after operation
measure: Postoperative pain score in NRS scale
timeFrame: Day "0", assessed 12 hour after operation
measure: Postoperative pain score in NRS scale
timeFrame: Day "0", assessed 24 hour after operation
Secondary outcomes:
measure: Postoperative sedation score
timeFrame: Day "0", assessed 1,6,12 and 24 hours after operation
measure: Postoperative nausea and vomiting
timeFrame: Day "0", assessed 1,6,12 and 24 hours after operation
measure: Highest BP
timeFrame: intraoperative
measure: Lowest BP
timeFrame: intraoperative
measure: Highest HR
timeFrame: intraoperative
measure: Lowest HR
timeFrame: intraoperative
measure: Total ephedrine dosis
timeFrame: intraoperative
measure: Postoperative desaturation
timeFrame: Day "0", assessed 1,6,12 and 24 hours after operation
measure: Blurred vision
timeFrame: Day "0", assessed 1,6,12 and 24 hours after operation
measure: Patient's comfort assessed in QoR-40 formulary
timeFrame: Day "0", assessed 24 hours after operation
measure: Postoperative oxycodone consumption
timeFrame: Day "0", assessed 1,6,12 and 24 hours after operation
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Szpital Kliniczny Dzieciatka Jezus
Study officials:
affiliation: Medical University of Warsaw
name: Piotr Mieszczański, MD
role: PRINCIPAL_INVESTIGATOR
References: