ObesityPhase 4NCT05804591
Pregabalin in the Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (LSG).
A Phase 4 study testing Pregabalin 150mg in people with Obesity and Postoperative Pain, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Postoperative Pain, Postoperative Nausea and Vomiting
- What is being tested?
- Pregabalin 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 24 Apr 2023to 1 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Szpital Kliniczny Dzieciatka Jezus
Warsaw, Warsaw, 02-005
Piotr Mieszczanski, +48669643205, piotr.mieszczanski@gmail.com
About this study
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.
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.
Read the 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.
- Being tested
- Pregabalin 150mg, Placebo
- Keywords
- Laparoscopic sleeve gastrectomy, Obesity, Pregabalin, Multimodal analgesia
- Medical subject headings
- Obesity, Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.
PlaceboDrug
1 capsule containing placebo per os 1 hour before start of the operation.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal analgesia group | Placebo comparator | Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards. Receives: Drug: Placebo |
| Multimodal analgesia with preemptive pregabalin group | Experimental | Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards. Receives: Drug: Pregabalin 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day "0"
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Measured: Day "0", assessed 1 hour after operation
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Measured: Day "0", assessed 6 hour after operation
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Measured: Day "0", assessed 12 hour after operation
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Measured: Day "0", assessed 24 hour after operation
Secondary outcomes (11)
Postoperative sedation score
1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive
Measured: Day "0", assessed 1,6,12 and 24 hours after operation
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
Measured: Day "0", assessed 1,6,12 and 24 hours after operation
Highest BP
Highest BP during operation
Measured: intraoperative
Lowest BP
Lowest BP during operation
Measured: intraoperative
Highest HR
Highest HR during operation
Measured: intraoperative
Lowest HR
Lowest HR during operation
Measured: intraoperative
Total ephedrine dosis
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
Measured: intraoperative
Postoperative desaturation
SpO2 < 94%
Measured: Day "0", assessed 1,6,12 and 24 hours after operation
Blurred vision
Presence of blurred or abnormal vision
Measured: Day "0", assessed 1,6,12 and 24 hours after operation
Patient's comfort assessed in QoR-40 formulary
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.
Measured: Day "0", assessed 24 hours after operation
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
Measured: Day "0", assessed 1,6,12 and 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start24 Apr 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Mieszczański, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804591
- Sponsor's protocol ID
- PreGab LSG
- Status last verified
- Jul 2024
- First submitted
- 26 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mieszczanski P, Gorniewski G, Janiak M, Trzebicki J. The effect of pre-emptive oral pregabalin on opioid consumption in patients undergoing laparoscopic sleeve gastrectomy with an analysis of intraoperative hemodynamic stability and quality of recovery: study protocol for a randomized, prospective, double-blind study. Trials. 2024 Jun 7;25(1):367. doi: 10.1186/s13063-024-08225-3.
PubMed 38849875
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05804591
- Acronym / sponsor ID
- PreGab LSG
- Keywords
- Laparoscopic sleeve gastrectomy, Obesity, Pregabalin, Multimodal analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal analgesia group | Placebo comparator | Drug: PlaceboPatients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards. |
| Multimodal analgesia with preemptive pregabalin group | Experimental | Drug: Pregabalin 150mgPatients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
- Written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin 150mgSingle dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation. | Drug | Multimodal analgesia with preemptive pregabalin group |
| Placebo1 capsule containing placebo per os 1 hour before start of the operation. | Drug | Multimodal analgesia group |
Primary outcome
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
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
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
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
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
11 secondary outcomes
Postoperative sedation score
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Postoperative nausea and vomiting
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Highest BP
Time frame: intraoperative
Lowest BP
Time frame: intraoperative
Highest HR
Time frame: intraoperative
Lowest HR
Time frame: intraoperative
Total ephedrine dosis
Time frame: intraoperative
Postoperative desaturation
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Blurred vision
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Patient's comfort assessed in QoR-40 formulary
Time frame: Day "0", assessed 24 hours after operation
Postoperative oxycodone consumption
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 38849875Mieszczanski P, Gorniewski G, Janiak M, Trzebicki J. The effect of pre-emptive oral pregabalin on opioid consumption in patients undergoing laparoscopic sleeve gastrectomy with an analysis of intraoperative hemodynamic stability and quality of recovery: study protocol for a randomized, prospective, double-blind study. Trials. 2024 Jun 7;25(1):367. doi: 10.1186/s13063-024-08225-3.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Mieszczański, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin 150mg in people with Obesity and Postoperative Pain, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Mieszczański, MD (669643205 ext. +48, piotr.mieszczanski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative oxycodone consumption (time frame: Day "0"). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05804591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.