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

Effect of Using Snap-Needle Therapy in Combination With Ginger Paste During Anesthesia Recovery on the Recovery of Gastrointestinal Function After Gynecologic Laparoscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Nausea and Vomiting; Gastrointestinal Motility
• Intervention / Treatment: Other: Acupuncture therapy; Other: Ginger Acupuncture Point Patch

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin Cheng, B.S; Phone Number: 17667404256; Email: 1318216353@qq.com

Study Locations

• China
  • Shandong
    • Weifang, Shandong, China, 261000
      • Recruiting
      • Lin Cheng
      • Contact: Lin Cheng, B.S; Phone Number: 17667404256; Email: 1318216353@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ASA I or II;
2. Performing gynecologic laparoscopic procedures under general anesthesia;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental group acupuncture(snap-needle); 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; 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.; Other Names: Qin acupuncture therapy; snap-needle therapy
Active Comparator: Experimental Ginger; 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; 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.
Active Comparator: Experimental group Acupuncture combined with ginger; 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; 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.; Other Names: Qin acupuncture therapy; snap-needle therapy; Other: Ginger Acupuncture Point Patch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 24 hours postoperatively.	Measured at 24 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 12 hours postoperatively.	Measured at 12 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of postoperative analgesic	Record the type and dosage of postoperative analgesic within 24 hours after surgery.	Approximately 24 hours after surgery.
Postoperative pain response	The Visual Analog Score was used to assess pain response at 0.5 hours postoperatively. The score ranges from 0 (pain free or no pain) to 10 (worst pain).	Measured at 0.5 hours postoperatively.
Postoperative pain response	The Visual Analog Score was used to assess pain response at 24 hours postoperatively. The score ranges from 0 (pain free or no pain) to 10 (worst pain).	Measured at 24 hours postoperatively.
Postoperative pain response	The Visual Analog Score was used to assess pain response at 1 hours postoperatively. The score ranges from 0 (pain free or no pain) to 10 (worst pain).	Measured at 1 hours postoperatively.
Postoperative pain response	The Visual Analog Score was used to assess pain response at 3 hours postoperatively. The score ranges from 0 (pain free or no pain) to 10 (worst pain).	Measured at 3 hours postoperatively.
Postoperative pain response	The Visual Analog Score was used to assess pain response at 6 hours postoperatively. The score ranges from 0 (pain free or no pain) to 10 (worst pain).	Measured at 6 hours postoperatively.
Postoperative pain response	The Visual Analog Score was used to assess pain response at 12 hours postoperatively. The score ranges from 0 (pain free or no pain) to 10 (worst pain).	Measured at 12 hours postoperatively.
Consumption of postoperative rescue antiemetic	Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.	Approximately 24 hours after surgery
Time to first defecation	Record the time of first defecation.	Approximately 24 hours after surgery.

Collaborators and Investigators

• Sponsor: Weifang Medical University
• Collaborators: Weifang People's Hospital
• Investigators: Principal Investigator: Lin Cheng, B.S, Weifang People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2024
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): September 20, 2024

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: PONV; Gastrointestinal Motility; Recovery of Function
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: KYLL20240117-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No