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

NCT06320613 — Not applicable, Unknown, 150 participants, Weifang Medical University

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

RegistryNCT06320613
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, prevention
Enrollment150 (Estimated)
SponsorWeifang Medical University (Other); collaborators: Weifang People's Hospital
ConditionsGastrointestinal Motility, Postoperative Nausea and Vomiting
InterventionsAcupuncture therapy, Ginger Acupuncture Point Patch (Other)
Datesstart 2024-03-20 (estimated), primary completion 2024-09-20 (estimated), completion 2024-09-20 (estimated), first posted 2024-03-20, last updated 2024-03-20
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Gastrointestinal Motility All trials for Postoperative Nausea and Vomiting All trials of Acupuncture therapy All trials of Ginger Acupuncture Point Patch

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Experimental group acupuncture(snap-needle)Active comparatorOther: Acupuncture therapyPatients 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.
Experimental GingerActive comparatorOther: Ginger Acupuncture Point PatchPatients 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.
Experimental group Acupuncture combined with gingerActive comparatorOther: Acupuncture therapy; Other: Ginger Acupuncture Point PatchPatients 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.
  • Acupuncture therapy (Other), also known as Qin acupuncture therapy, snap-needle 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 (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.

+Outcome measures

Primary outcomes

  • Postoperative nausea and vomiting [Measured at 0.5 hours postoperatively.]: 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.
  • Postoperative nausea and vomiting [Measured at 1 hours postoperatively.]: 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.
  • Postoperative nausea and vomiting [Measured at 3 hours postoperatively.]: 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.
  • Postoperative nausea and vomiting [Measured at 6 hours postoperatively.]: 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.
  • Postoperative nausea and vomiting [Measured at 12 hours postoperatively.]: 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.
  • Postoperative nausea and vomiting [Measured at 24 hours postoperatively.]: 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.
  • Abdominal distention [Measured at 0.5 hours postoperatively.]: The severity and incidence of Abdominal distention at 0.5 hours postoperatively.
  • Abdominal distention [Measured at 1 hours postoperatively.]: The severity and incidence of Abdominal distention at 1 hours postoperatively.
  • Abdominal distention [Measured at 3 hours postoperatively.]: The severity and incidence of Abdominal distention at 3 hours postoperatively.
  • Abdominal distention [Measured at 6 hours postoperatively.]: The severity and incidence of Abdominal distention at 6 hours postoperatively.
  • Abdominal distention [Measured at 12 hours postoperatively.]: The severity and incidence of Abdominal distention at 12 hours postoperatively.
  • Abdominal distention [Measured at 24 hours postoperatively.]: The severity and incidence of Abdominal distention at 24 hours postoperatively.
  • Time to first flatus [Approximately 24 hours after surgery.]: Record the time of the first flatus. The earlier the time of first flatus, the earlier the time of recovery of gastrointestinal function.

Secondary outcomes

  • Postoperative pain response [Measured at 0.5 hours postoperatively.]: 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).
  • Postoperative pain response [Measured at 1 hours postoperatively.]: 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).
  • Postoperative pain response [Measured at 3 hours postoperatively.]: 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).
  • Postoperative pain response [Measured at 6 hours postoperatively.]: 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).
  • Postoperative pain response [Measured at 12 hours postoperatively.]: 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).
  • Postoperative pain response [Measured at 24 hours postoperatively.]: 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).
  • Consumption of postoperative analgesic [Approximately 24 hours after surgery.]: Record the type and dosage of postoperative analgesic within 24 hours after surgery.
  • Consumption of postoperative rescue antiemetic [Approximately 24 hours after surgery]: Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.
  • Time to first defecation [Approximately 24 hours after surgery.]: Record the time of first defecation.

+Eligibility

Sex: Female, ages: 18 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
Lin ChengWeifang, ShandongChinaRecruiting

+Investigators