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

ConditionsObesityPostoperative PainPostoperative Nausea and VomitingOpioid Use
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Warsaw

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities

Written informed consent

Disqualifiers

Patient's refusal

Known allergies to study medication

Inability to comprehend or participate In pain scoring scale

Inability to use intravenous patient controlled analgesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Multimodal analgesia groupPlacebo comparator 1 intervention
Group B: Multimodal analgesia with preemptive pregabalin groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day "0"
2

Postoperative pain score in NRS scale

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

Time frame
Day "0", assessed 1 hour after operation
3

Postoperative pain score in NRS scale

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

Time frame
Day "0", assessed 6 hour after operation
4

Postoperative pain score in NRS scale

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

Time frame
Day "0", assessed 12 hour after operation

Secondary outcomes

1

Postoperative sedation score

1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive

Time frame
Day "0", assessed 1,6,12 and 24 hours after operation
2

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

Time frame
Day "0", assessed 1,6,12 and 24 hours after operation
3

Highest BP

Highest BP during operation

Time frame
intraoperative
4

Lowest BP

Lowest BP during operation

Time frame
intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Warsaw

Lead sponsor

Source ClinicalTrials.gov
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