ClinicalTrials.gg
Not yet recruitingNCT07933640Updated Nov 12, 2026

A Clinical Study on Vagus Nerve Blockade at the Gastroesophageal Junction Combined With Tegileridine in the Very Early Postoperative Recovery Following Bariatric Surgery

An interventional study of Bilateral transverse abdominal plane block and intravenous administration of Tegileridine combined with the vagus nerve block at the gastroesophageal junction and Bilateral Transversus Abdominis Plane Block (TAPB) and Intravenous infusion of Tegileridine. in Visceral Pain, Postoperative, Bariatric Surgery and Nerve Block, sponsored by The First Affiliated Hospital of Xiamen University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Prevention

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Visceral Pain, Postoperative
  • Bariatric Surgery
  • Nerve Block

Browse trials for

03

In context

Visceral Pain

55 studies on the registry are indexed under Visceral Pain; 19 are open to participants now.

This study's planned enrollment of 86 is above the median of 72 across 47 interventional studies indexed under Visceral Pain.

Browse Visceral Pain studies →

Lead sponsor

The First Affiliated Hospital of Xiamen University is the lead sponsor of 120 studies on the registry; 81 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 to 70 years, regardless of gender;
  • meets the clinical criteria for bariatric surgery;
  • 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 form

Exclusion criteria

Exclusion Criteria:

  • 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;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
86 participants (estimated)

Study arms

  • Active comparator
    The control group

    Bilateral transverse abdominal plane block and intravenous administration of Tegileridine

    Procedure: Bilateral Transversus Abdominis Plane Block (TAPB) and Intravenous infusion of Tegileridine.

  • Experimental
    The experimental group

    Bilateral transverse abdominal plane block and intravenous administration of Tegileridine combined with the vagus nerve block at the gastroesophageal junction

    Procedure: Bilateral transverse abdominal plane block and intravenous administration of Tegileridine combined with the vagus nerve block at the gastroesophageal junction

Interventions

  • ProcedureBilateral 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.

  • ProcedureBilateral Transversus Abdominis Plane Block (TAPB) and Intravenous infusion 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.

06

What researchers measure

Primary outcomes

  1. Visual analogue scale (VAS) Score

    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.

    Time frame: postoperative 0, 2, 6, 12, and 24 hours

Secondary outcomes

  1. Quality-of-Recovery 15 (QoR-15) Score

    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.

    Time frame: postoperative 1 day

  2. Incidence of postoperative respiratory depression

    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.

    Time frame: postoperative 1, 2, 3 days

  3. Rescue analgesia rate

    Time frame: postoperative 1, 2, 3 days

  4. Total dose of sufentanil for rescue analgesia

    Time frame: postoperative 1, 2, 3 days

  5. Time of first ambulation

    Time frame: postoperative 1, 2, 3 days

  6. Total Hospital Stay

    Time frame: postoperative 7 days

  7. Adverse effects

    Time frame: postoperative 1, 2, 3 days

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2028, 16 months later.

Of 16 interventional studies with no phase under Visceral Pain, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 33. This study's planned 16 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2026
First posted
Nov 12, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Mar 15, 2028
CompletionEst.
Sep 30, 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07933640
Responsible party
Yang Bin (Chief physician, The First Affiliated Hospital of Xiamen University) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Mar 15, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion