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

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05804591
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Participants will be divided into 2 groups: with or without preemptive pregabalin administration.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Postoperative Pain; Postoperative Nausea and Vomiting; Opioid Use	Drug: Pregabalin 150mg; Drug: Placebo	Phase 4

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.

We 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Multimodal analgesia group Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.	Drug: Placebo; 1 capsule containing placebo per os 1 hour before start of the operation.
Experimental: Multimodal analgesia with preemptive pregabalin group Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.	Drug: Pregabalin 150mg; Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. Postoperative pain score in NRS scale [Day "0", assessed 6 hour after operation]

   NRS range from 0 for no pain to 10 for worst pain imaginable

4. Postoperative pain score in NRS scale [Day "0", assessed 12 hour after operation]

   NRS range from 0 for no pain to 10 for worst pain imaginable

5. 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

1. 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

2. 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

3. Highest BP [intraoperative]

   Highest BP during operation

4. Lowest BP [intraoperative]

   Lowest BP during operation

5. Highest HR [intraoperative]

   Highest HR during operation

6. Lowest HR [intraoperative]

   Lowest HR during operation

7. 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

8. Postoperative desaturation [Day "0", assessed 1,6,12 and 24 hours after operation]

   SpO2 < 94%

9. Blurred vision [Day "0", assessed 1,6,12 and 24 hours after operation]

   Presence of blurred or abnormal vision

10. Patient's comfort assessed in QoR-40 formulary [Day "0", assessed 24 hours after operation]

    QoR-40 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.

11. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Szpital Kliniczny Dzieciatka Jezus	Warsaw		Poland	02-005

Sponsors and Collaborators

• Medical University of Warsaw

Investigators

• Principal Investigator: Piotr Mieszczański, MD, Medical University of Warsaw

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT05804591
• Other Study ID Numbers: PreGab LSG
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medical University of Warsaw: Laparoscopic sleeve gastrectomy; Obesity; Pregabalin; Multimodal analgesia
• Additional relevant MeSH terms: Vomiting; Postoperative Nausea and Vomiting; Pregabalin

Study Results

No Results Posted as of Apr 7, 2023