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

NCT07607249 | Enrolling By Invitation

• 1 other identifier: YF2026-112-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Dysfunction

Keywords

Gastrointestinal dysfunction; postoperative gastrointestinal disorder; Fu's Subcutaneous Needling; FSN; Fu's Acupuncture; FSN acupuncture Needle; Knee Surgery

Outcome Measures

Primary Outcomes (2)

• The first postoperative exhaust and defecation time

  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

  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

Secondary Outcomes (2)

• Gastrointestinal Symptom Rating Scale, GSRS

  hour 6/hour 12/hour 36

• Five-point Likert scale for abdominal distension

  hour 6/hour 12/hour 36

Study Arms (2)

Conventional treatment group

ACTIVE COMPARATOR

Drug: Mosapride

Fu's Acupuncture group

EXPERIMENTAL

Device: Fu's Acupuncture group

Interventions

Fu's Acupuncture group DEVICE

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.

Fu's Acupuncture group

Mosapride DRUG

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.

Conventional treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Underwent elective knee surgery under general anesthesia;
• Had normal bowel habits prior to hospital admission;
• Were aged 18-80 years;
• Had no severe systemic comorbidities or organic gastrointestinal disorders;
• 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.

You may not qualify if:

• 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;
• 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);
• Patients with primary immunodeficiency disorders, active systemic infections, or uncontrolled autoimmune diseases;
• Patients with recent abdominal trauma, acute surgical abdomen, or documented hypersensitivity to any intervention-related medications or materials;
• Presence of active dermatological conditions-including macules, papules, erythema, urticaria, abrasions, lacerations, or ulcerations-at the intended site of Fu's subcutaneous needle insertion;
• Patients exhibiting severe needle phobia, persistent vertigo, or cognitive/psychological impairment that precludes reliable adherence to treatment protocols or informed consent procedures;
• 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.

Sponsors & Collaborators

• Zhenyu Zhang: lead
• Guangzhou University of Chinese Medicine: collaborator

Study Sites (1)

Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

mosapride

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident doctor

Model Details: The control group was treated with routine treatment, and the treatment group was treated with Fu's subcutaneous needling on the basis of routine treatment

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 26, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): March 27, 2027
• Study Completion (Estimated): March 27, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)