Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05804591

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity Body Weight Nausea Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Opioid Use Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Szpital Kliniczny Dzieciatka Jezus

Warsaw, 02-005, Poland

Location status: Recruiting

Location contact

Piotr Mieszczanski

CONTACT

[email protected]

+48669643205

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin 150mg

Drug

Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.

Placebo

Drug

1 capsule containing placebo per os 1 hour before start of the operation.

Primary outcomes

  1. Total postoperative oxycodone consumption

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day "0", assessed 24 hour after operation

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

Secondary outcomes

  1. Postoperative sedation score

    Time frame: 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

    Time frame: 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

    Time frame: intraoperative

    Highest BP during operation

  4. Lowest BP

    Time frame: intraoperative

    Lowest BP during operation

  5. Highest HR

    Time frame: intraoperative

    Highest HR during operation

  6. Lowest HR

    Time frame: intraoperative

    Lowest HR during operation

  7. Total ephedrine dosis

    Time frame: 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

    Time frame: Day "0", assessed 1,6,12 and 24 hours after operation

    SpO2 < 94%

  9. Blurred vision

    Time frame: 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

    Time frame: 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.

  11. Postoperative oxycodone consumption

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Piotr Mieszczański, MD

CONTACT

[email protected]

669643205 ext. +48

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.