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Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle

21 de maio de 2026 atualizado por: Zhenyu Zhang
A randomized controlled trial was conducted to compare the clinical efficacy of Fu's subcutaneous acupuncture and western medication in the treatment of gastrointestinal dysfunction after knee surgery under general anesthesia. The difference in clinical efficacy between the Fu's subcutaneous acupuncture group and the western medication group was analyzed, and the mechanism of Fu's subcutaneous acupuncture in the treatment of gastrointestinal dysfunction after general anesthesia was further explored. It was confirmed that Fu's subcutaneous acupuncture can effectively promote postoperative gastrointestinal motility and reduce postoperative gastrointestinal discomfort. It can shorten the recovery time of gastrointestinal function, improve the quality of life of patients during the perioperative period, and explore the improvement of postoperative complications and promote the postoperative rehabilitation of patients, which is worthy of clinical application.

Visão geral do estudo

Status

Inscrevendo-se por convite

Descrição detalhada

Postoperative gastrointestinal dysfunction refers to the symptoms such as abdominal distension, nausea and vomiting, constipation, and weakened or disappeared bowel sounds caused by preoperative anesthesia, postoperative fasting, use of analgesics, prolonged bed rest, and early drinking after surgery. It is a common complication of surgery. The use of opioid analgesics during and after general anesthesia can bind to the opioid receptors distributed in the presynaptic neurons of the intestinal muscle layer, resulting in the decrease of intestinal peristalsis waves and the cessation of motility, leading to the occurrence of postoperative gastrointestinal dysfunction, with an incidence of up to 81%. The delayed recovery of gastrointestinal function after surgery can lead to intestinal obstruction or paralysis, anastomotic leakage and other complications. It not only has adverse effects on the recovery process and quality of life, but also may increase the consumption of medical resources. Studies have shown that the incidence of Postoperative gastrointestinal dysfunction in abdominal surgery can be as high as 10% to 30%. In recent years, the incidence of Postoperative gastrointestinal dysfunction has not decreased significantly, but has increased by 10% in Japan. Patients with Postoperative gastrointestinal dysfunction have a longer hospital stay than those without POGD, and have more postoperative complications such as infection and postoperative intestinal obstruction, which brings a greater economic burden to patients and society. At present, a simple, convenient and effective method to restore gastrointestinal function is the key to reduce postoperative complications and rapid recovery to reduce the length of hospital stay, and it is also the key problem to be solved during the perioperative period.

Tipo de estudo

Intervencional

Inscrição (Estimado)

72

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangzhou University of Chinese Medicine

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Met the diagnostic criteria for postoperative gastrointestinal dysfunction as defined in the Clinical Practice Guidelines for the Prevention and Treatment of Postoperative Gastrointestinal Dysfunction Using Integrated Traditional Chinese and Western Medicine;
  2. Underwent elective knee surgery under general anesthesia;
  3. Had normal bowel habits prior to hospital admission;
  4. Were aged 18-80 years;
  5. Had no severe systemic comorbidities or organic gastrointestinal disorders;
  6. Provided written informed consent after receiving comprehensive information regarding the study's objectives, procedures, potential benefits, and associated risks.

All patients in both groups received standard postoperative symptomatic management, including routine wound dressing changes and patient-controlled analgesia.

Exclusion Criteria:

  1. Patients with chronic diarrhea or constipation attributable to organic etiologies; those with confirmed organic lesions of the large intestine (e.g., inflammatory bowel disease, diverticulosis, or neoplasms); individuals diagnosed with malignant tumors; patients who developed postoperative complications including intra-abdominal infection, abdominal hemorrhage, or cerebrovascular events requiring transfer to the intensive care unit;
  2. Patients with severe cardiac, hepatic, or renal dysfunction (e.g., NYHA Class IV heart failure, Child-Pugh Class C cirrhosis, or estimated glomerular filtration rate <30 mL/min/1.73 m²);
  3. Patients with primary immunodeficiency disorders, active systemic infections, or uncontrolled autoimmune diseases;
  4. Patients with recent abdominal trauma, acute surgical abdomen, or documented hypersensitivity to any intervention-related medications or materials;
  5. Presence of active dermatological conditions-including macules, papules, erythema, urticaria, abrasions, lacerations, or ulcerations-at the intended site of Fu's subcutaneous needle insertion;
  6. Patients exhibiting severe needle phobia, persistent vertigo, or cognitive/psychological impairment that precludes reliable adherence to treatment protocols or informed consent procedures;
  7. Patients who initiated concomitant therapies (pharmacologic or non-pharmacologic) not stipulated in the study protocol after enrollment, thereby confounding efficacy assessment; and those with incomplete baseline or follow-up data essential for primary or secondary outcome evaluation.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Conventional treatment group
On the basis of routine postoperative care, the patients in the control group were treated with mosapride citrate tablets (Runan Beite Pharmaceutical Co., LTD., Chinese Medicine approved number H19990317, standard: 5mg), 5mg/ time, 3 times /d.
Experimental: Fu's Acupuncture group
The Fu's Acupuncture group received treatment 6 hours after the operation. One treatment session was conducted. The therapeutic effects were observed at 1 hour, 12 hours, and 36 hours after the treatment.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The first postoperative exhaust and defecation time
Prazo: 6 hours/12 hours/36 hours/72 hours
  1. Exhaust time was recorded as the interval from the end of the operation to the first exhaust.
  2. Defecation time was recorded as the interval from the end of surgery to the first defecation.

The first postoperative exhaust and defecation time were recorded at 6 hours, 12 hours, 36 hours and 72 hours after operation

6 hours/12 hours/36 hours/72 hours
Recovery time of bowel sounds
Prazo: 6 hours /12 hours /36 hours /72 hours

Recovery time of bowel sounds: auscultation was performed 6 hours after the operation in both groups, and the bowel sounds were recorded 6 hours /12 hours /36 hours /72 hours after the operation. During abdominal auscultation, five key auscultation areas were selected: left lower abdomen, left upper abdomen, right upper abdomen, right lower abdomen and around the umbilicus (G letter shape). At least 3 minutes of auscultation per auscultation area, bowel sounds were assessed as being in the normal range only if they were heard in two or more areas at a frequency of (3-5) beats/min. The patients in the treatment group were treated with Fu's subcutaneous needling after operation, and the bowel sounds were recorded once after each treatment. Each auscultation was recorded by a special person.

Postoperative bowel sound recovery time: the time between the end of surgery and the time when bowel sounds returned to normal.

6 hours /12 hours /36 hours /72 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Gastrointestinal Symptom Rating Scale, GSRS
Prazo: hour 6/hour 12/hour 36
According to the Chinese version of gastrointestinal symptom rating scale, GSRS included 15 items of abdominal pain, abdominal distension, nausea, vomiting, belching, acid reflux, satiety, loss of appetite, abdominal burning, abdominal discomfort, abnormal bowel sounds, difficult exhaust, incomplete defecation, dry stool and straining defecation. The severity and frequency of GSRS were evaluated. The sum of the scores of the two dimensions of all symptoms was the GSRS score, which ranged from 0 to 60, with higher scores indicating more severe symptoms. The GSRS scores were calculated immediately, 6h, 12h and 36h after treatment.
hour 6/hour 12/hour 36
Five-point Likert scale for abdominal distension
Prazo: hour 6/hour 12/hour 36
The degree of abdominal distension of the two groups was recorded before treatment, 6 h, 12 h and 36 h after treatment. The abdominal distension score was formulated according to the "Practical Integrated Traditional Chinese and Western Medicine Diagnosis and Therapy" and related literature using the 5-point Likert scale.For example, score 0: no abdominal distension or discomfort throughout the day; Score 1: occasional abdominal distention and discomfort throughout the day, but did not affect rest; score 2: persistent abdominal distention and discomfort for a long time throughout the day, affecting rest but could tolerate; Score 3: abdominal distension and discomfort for a long time throughout the day, affecting rest but can be tolerated; Score 4: persistent abdominal distention and discomfort throughout the day, affecting rest and requiring medication; 5 points: persistent severe abdominal distention and discomfort throughout the day, abdominal distention, percussion drum sounds
hour 6/hour 12/hour 36

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de março de 2026

Conclusão Primária (Estimado)

27 de março de 2027

Conclusão do estudo (Estimado)

27 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

29 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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