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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320613
• Other study ID #: KYLL20240117-2
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: September 20, 2024

Study information

• Verified date: March 2024
• Source: Weifang Medical University
• Contact: Lin Cheng, B.S
• Phone: 17667404256
• Email: 1318216353[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 20, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Motility
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Lin Cheng	Weifang	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Weifang Medical University	Weifang People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Abdominal distention	The severity and incidence of Abdominal distention at 0.5 hours postoperatively.	Measured at 0.5 hours postoperatively.
Primary	Abdominal distention	The severity and incidence of Abdominal distention at 1 hours postoperatively.	Measured at 1 hours postoperatively.
Primary	Abdominal distention	The severity and incidence of Abdominal distention at 3 hours postoperatively.	Measured at 3 hours postoperatively.
Primary	Abdominal distention	The severity and incidence of Abdominal distention at 6 hours postoperatively.	Measured at 6 hours postoperatively.
Primary	Abdominal distention	The severity and incidence of Abdominal distention at 12 hours postoperatively.	Measured at 12 hours postoperatively.
Primary	Abdominal distention	The severity and incidence of Abdominal distention at 24 hours postoperatively.	Measured at 24 hours postoperatively.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Consumption of postoperative analgesic	Record the type and dosage of postoperative analgesic within 24 hours after surgery.	Approximately 24 hours after surgery.
Secondary	Consumption of postoperative rescue antiemetic	Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.	Approximately 24 hours after surgery
Secondary	Time to first defecation	Record the time of first defecation.	Approximately 24 hours after surgery.