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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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;
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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. |
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Visual analogue scale (VAS) Score
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality-of-Recovery 15 (QoR-15) Score
기간: 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
기간: 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
기간: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
|
Total dose of sufentanil for rescue analgesia
기간: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
|
Time of first ambulation
기간: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
|
Total Hospital Stay
기간: postoperative 7 days
|
postoperative 7 days
|
|
|
Adverse effects
기간: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FirstAHXiamenU-YB-5
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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