A Clinical Study on Vagus Nerve Blockade at the Gastroesophageal Junction Combined With Tegileridine in the Very Early Postoperative Recovery Following Bariatric Surgery
This study aims to investigate, through a prospective randomized controlled clinical trial, the clinical value of vagal nerve block at the gastroesophageal junction combined with tizanidine in the very early postoperative recovery following bariatric surgery. Patients who have undergone bariatric surgery often experience visceral pain due to the inflammatory response triggered by partial gastrectomy. Conventional analgesic regimens have limited efficacy in controlling this type of visceral pain, whereas vagus nerve block at the gastroesophageal junction can directly block the transmission of pain signals from this region, thereby specifically alleviating visceral pain; the combined use of tegileridine could reduce postoperative opioid dosage and lower the risk of related adverse reactions. By comparing these two different analgesic regimens, this study examines their effects on patients' postoperative pain intensity, early mobilization, and adverse reactions such as respiratory depression, nausea, vomiting, and constipation. This study aims to clarify the efficacy and safety of this combined regimen in precisely relieving visceral pain, optimizing perioperative analgesia, reducing opioid-related complications, alleviating gastrointestinal adverse reactions, promoting early ambulation, and accelerating recovery, thereby providing clinical evidence for the establishment of a more comprehensive and individualized multimodal analgesia and Enhanced Recovery After Surgery (ERAS) system for bariatric surgery.
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Aged 18 to 70 years, regardless of gender;
- BMI meets the clinical criteria for bariatric surgery;
- ASA physical status classification I-II;
- Scheduled to undergo laparoscopic sleeve gastrectomy or gastric bypass surgery;
- Fully understands the details of this study, voluntarily agrees to participate, and has signed a written informed consent form
Exclusion Criteria:
- Contraindications for regional nerve block procedures (e.g., coagulation disorders, infection at the puncture site, etc.);
- Allergy to local anesthetics, tizanidine, or opioids;
- Severe cardiac, pulmonary, hepatic, or renal dysfunction;
- History of chronic pain or long-term use of opioid analgesics prior to surgery;
- Pregnant or breastfeeding women;
- Mental illness or cognitive impairment that prevents the participant from cooperating with pain scoring and other assessments;
- Other circumstances deemed by the investigator to make the participant unsuitable for participation in this study;
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: The control group
Bilateral transverse abdominal plane block and intravenous administration of Tegileridine |
Bilateral Transversus Abdominis Plane Block (TAPB): Ultrasound-guided TAPB, 20 mL of 0.25% ropivacaine on each side. Intravenous infusion of 1 mg of Tegileridine. |
|
Experimenteel: The experimental group
Bilateral transverse abdominal plane block and intravenous administration of Tegileridine combined with the vagus nerve block at the gastroesophageal junction |
Bilateral Transversus Abdominis Plane Block (TAPB): Ultrasound-guided TAPB, 20 mL of 0.25% ropivacaine on each side. Intravenous infusion of 1 mg of Tegileridine. Vagus nerve block at the gastroesophageal junction: Under direct laparoscopic visualization, locate the vagus nerve trunks on both sides of the gastroesophageal junction and inject 3 mL of 0.33% ropivacaine into each side. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Visual analogue scale (VAS) Score
Tijdsspanne: postoperative 0, 2, 6, 12, and 24 hours
|
The VAS score refers to drawing a 10-cm scale on a piece of paper. One end of the scale is marked as 0, indicating no pain; the other end is marked as 10, indicating severe pain; the values in between represent different degrees of pain. |
postoperative 0, 2, 6, 12, and 24 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quality-of-Recovery 15 (QoR-15) Score
Tijdsspanne: postoperative 1 day
|
The QoR-15 includes 5 items related to physical comfort, 4 items regarding emotional state, 2 items concerning self-care ability, 2 items related to psychological support, and 2 items about pain. There are a total of 15 subjective parameters. Each item is scored on a scale of 0 to 10. The total score of QoR-15 ranges from 0 to 150. The higher the score, the better the condition. |
postoperative 1 day
|
|
Incidence of postoperative respiratory depression
Tijdsspanne: postoperative 1, 2, 3 days
|
Postoperative respiratory depression is defined as a sustained (>1 minute) decrease in oxygen saturation to <90%, or a respiratory rate of <8 breaths per minute, or a decrease in oxygen saturation to <94% accompanied by a respiratory rate of <10 breaths per minute, requiring supplemental oxygen to maintain oxygen saturation (SpO₂) >94%, and in the absence of obvious upper airway obstruction. |
postoperative 1, 2, 3 days
|
|
Rescue analgesia rate
Tijdsspanne: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
|
Total dose of sufentanil for rescue analgesia
Tijdsspanne: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
|
Time of first ambulation
Tijdsspanne: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
|
Total Hospital Stay
Tijdsspanne: postoperative 7 days
|
postoperative 7 days
|
|
|
Adverse effects
Tijdsspanne: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FirstAHXiamenU-YB-5
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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