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

Phase 4

Recruiting

• Conditions: Postoperative Nausea and Vomiting; Opioid Use; Obesity; Postoperative Pain
• Interventions: Drug: Pregabalin 150mg; Drug: Placebo

• Registration Number: NCT05804591
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-03-26
• Status Verified: 2023-04
• Study First Posted: 2023-04-07
• Study Start: 2023-04-24
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27
• Primary Completion: 2025-04-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal analgesia with preemptive pregabalin group	Pregabalin 150mg	Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.
Multimodal analgesia group	Placebo	Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.

Primary Outcome Measures

Name	Time	Method
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 24 hour after operation	NRS range from 0 for no pain to 10 for worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Lowest BP	intraoperative	Lowest BP during operation
Highest HR	intraoperative	Highest HR during operation
Blurred vision	Day "0", assessed 1,6,12 and 24 hours after operation	Presence of blurred or abnormal vision
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 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
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 HR	intraoperative	Lowest HR during operation
Postoperative desaturation	Day "0", assessed 1,6,12 and 24 hours after operation	SpO2 \< 94%
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
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.

Trial Locations

Locations (1)

Szpital Kliniczny Dzieciatka Jezus; 🇵🇱 Warsaw, Poland