Effect of Implementing Snap-needle Therapy Combined With Ginger Paste During Anesthesia Recovery on the Recovery of Gastrointestinal Function After Gynecologic Laparoscopy

NCT06320613 | Recruiting

• 1 other identifier: KYLL20240117-2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effect of implementing snap-needle therapy combined with ginger paste during anesthesia recovery on the recovery of gastrointestinal function after gynecological laparoscopy.

Conditions

Gastrointestinal Motility; Postoperative Nausea and Vomiting

Keywords

Gastrointestinal Motility; Recovery of Function; PONV

Outcome Measures

Primary Outcomes (13)

• Postoperative nausea and vomiting

  The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 0.5 hours postoperatively.

  Measured at 0.5 hours postoperatively.

• Postoperative nausea and vomiting

  The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 1 hours postoperatively.

  Measured at 1 hours postoperatively.

• Postoperative nausea and vomiting

  The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 3 hours postoperatively.

  Measured at 3 hours postoperatively.

• Postoperative nausea and vomiting

  The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 6 hours postoperatively.

  Measured at 6 hours postoperatively.

• Postoperative nausea and vomiting

  The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 12 hours postoperatively.

  Measured at 12 hours postoperatively.

• Postoperative nausea and vomiting

  The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 24 hours postoperatively.

  Measured at 24 hours postoperatively.

• Abdominal distention

  The severity and incidence of Abdominal distention at 0.5 hours postoperatively.

  Measured at 0.5 hours postoperatively.

• Abdominal distention

  The severity and incidence of Abdominal distention at 1 hours postoperatively.

  Measured at 1 hours postoperatively.

• Abdominal distention

  The severity and incidence of Abdominal distention at 3 hours postoperatively.

  Measured at 3 hours postoperatively.

• Abdominal distention

  The severity and incidence of Abdominal distention at 6 hours postoperatively.

  Measured at 6 hours postoperatively.

• Abdominal distention

  The severity and incidence of Abdominal distention at 12 hours postoperatively.

  Measured at 12 hours postoperatively.

• Abdominal distention

  The severity and incidence of Abdominal distention at 24 hours postoperatively.

  Measured at 24 hours postoperatively.

• Time to first flatus

  Record the time of the first flatus. The earlier the time of first flatus, the earlier the time of recovery of gastrointestinal function.

  Approximately 24 hours after surgery.

Secondary Outcomes (9)

• Postoperative pain response

  Measured at 0.5 hours postoperatively.

• Postoperative pain response

  Measured at 1 hours postoperatively.

• Postoperative pain response

  Measured at 3 hours postoperatively.

• Postoperative pain response

  Measured at 6 hours postoperatively.

• Postoperative pain response

  Measured at 12 hours postoperatively.

Study Arms (3)

Experimental group acupuncture(snap-needle)

ACTIVE COMPARATOR

Patients in the acupuncture group received acupuncture therapy (snap-needle therapy) for 24 hours. Results of the study were collected at six assessment periods of 0-0.5 h, 0-1 h, 1-3 h, 4-6h, 6-12 h, and 12-24 h after anesthesia. Conducted by an independent researcher.

Other: Acupuncture therapy

Experimental Ginger

ACTIVE COMPARATOR

Patients in the Ginger Acupuncture Point Patch group received ginger patch therapy and the ginger patch was removed within 6h. Study results were collected at six assessment periods of 0-0.5h, 0-1h, 1-3h, 4-6h, 6-12h, and 12-24h after anesthesia. Conducted by an independent researcher.

Other: Ginger Acupuncture Point Patch

Experimental group Acupuncture combined with ginger

ACTIVE COMPARATOR

Patients in the Acupuncture combined with ginger group received acupuncture treatment (snap-needle therapy) combined with ginger compresses, which were removed within 6h and snap-needles were removed after 24 hours. Study results were collected at six assessment periods of 0-0.5h, 0-1h, 1-3h, 4-6h, 6-12h, and 12-24h after anesthesia. Conducted by an independent researcher.

Other: Acupuncture therapy; Other: Ginger Acupuncture Point Patch

Interventions

Acupuncture therapy OTHER

After disinfecting (alcohol or 0.9% Normal saline) the skin at the acupuncture point, use small tweezers to clip the handle of the needle, remove the adhesive tape and stab the acupuncture point at a perpendicular angle, and then press the thumb with moderate pressure on the snap-needle embedded needle site in order for the patient to feel localized soreness and distension as appropriate. The snap-needle was removed after 24 hours, and the pressing time point remained unchanged.

Also known as: Qin acupuncture therapy, snap-needle therapy

Experimental group Acupuncture combined with ginger; Experimental group acupuncture(snap-needle)

Ginger Acupuncture Point Patch OTHER

Ginger was thinly sliced and then cut into 2-3cm diameter ginger discs according to a circular mold and covered with a sterile circular dressing. The ginger compress was removed within 6 hours.

Experimental Ginger; Experimental group Acupuncture combined with ginger

Eligibility Criteria

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

You may qualify if:

• ASA I or II;
• Performing gynecologic laparoscopic procedures under general anesthesia;

You may not qualify if:

• Age ≤ 18 or ≥65;
• The patient has a previous history of PONV, digestive disorders, etc;
• Ulcers, infections, and skin tears at acupressure and acupuncture (snap-needle) treatment sites;
• Patients allergic to ginger；
• Inability to follow protocol or refusal to participant

Sponsors & Collaborators

• Weifang Medical University: lead
• Weifang People's Hospital: collaborator

Study Sites (1)

Lin Cheng

Weifang, Shandong, 261000, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lin Cheng, B.S

  Weifang People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Cheng, B.S

CONTACT

17667404256; 1318216353@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 20, 2024
• Study Start: March 20, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)