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New treatment option for Postoperative Nausea and Vomiting
Official title Paragastric Block for Pain and PONV in Sleeve Gastrectomy
ClinicalTrials.gov ID: NCT07274215
What this study is testing
What is Bupivacaine 0.5%?
Bupivacaine 0.5% is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for postoperative nausea and vomiting.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This single-center, prospective, randomized, double-blind controlled trial aims to evaluate the effects of intraoperative paragastric block (PGBLOCK) on early postoperative visceral pain, postoperative nausea and vomiting (PONV), and analgesic requirements in patients undergoing laparoscopic sleeve gastrectomy (LSG). Despite advancements in multimodal analgesia protocols, visceral pain remains a significant postoperative concern following LSG, contributing to increased opioid use and delayed recovery.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients aged between 18 and 65 years.
- Candidates scheduled for elective LSG.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Ability to provide written informed consent and willingness to comply with study procedures.
You likely can't join if
- History of prior upper abdominal surgery.
- Known psychiatric or neurological disorders that could interfere with pain assessment or postoperative care.
- History of opioid dependency or chronic opioid use.
- Allergy or hypersensitivity to local anesthetics or any of the medications used in the study protocol (e.g., paracetamol, dexketoprofen, ondansetron...
- Severe hepatic, renal, or cardiac dysfunction (e.g., cirrhosis, end-stage renal disease, heart failure).
- Pregnancy or breastfeeding.
See the full eligibility criteria
- Patients aged between 18 and 65 years.
- Candidates scheduled for elective LSG.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Ability to provide written informed consent and willingness to comply with study procedures.
- History of prior upper abdominal surgery.
- Known psychiatric or neurological disorders that could interfere with pain assessment or postoperative care.
- History of opioid dependency or chronic opioid use.
- Allergy or hypersensitivity to local anesthetics or any of the medications used in the study protocol (e.g., paracetamol, dexketoprofen, ondansetron, tramadol, metoclopramide).
- Severe hepatic, renal, or cardiac dysfunction (e.g., cirrhosis, end-stage renal disease, heart failure).
- Pregnancy or breastfeeding.
- Concomitant surgery (e.g., cholecystectomy, hiatal hernia repair, or abdominal wall repair).
- Known bleeding disorders or coagulopathy (e.g., INR \>1.5, platelet count \<50,000/mm³, or ongoing anticoagulant therapy)
The study team makes the final eligibility decision.
Where it's taking place
- Istanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.