The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy

Acupuncture Clinical Trial

Official title:

The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759079
• Other study ID #: 22917
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: February 5, 2021

Study information

• Verified date: February 2021
• Source: University of West Attica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative nausea and vomiting (PONV), represents a common condition after surgery and anesthesia. Acupuncture has been used for centuries for analgesia and quality of life improvement in addition to low cost. This study is a random control trial concerning the antiemetic efficacy of acupuncture associated with intravenous antiemetics in laparoscopic cholecystectomy, in comparison to patients under only antiemetic administration.

One hundred patients were enrolled, regardless of their sex, age, and comorbidity and were randomly allocated in one of two groups. Both anesthesia and antiemetic medication were personalized according to each patient's medical history. In the study group, after anesthesia induction and before pneumoperitoneum application, a sterile stainless steel 0,25 x 25mm acupuncture needle was inserted bilaterally at the PC6 for 20 minutes, rotated manually clockwise and then anticlockwise every 5 minutes and then removed. Fisher's exact test was chosen for statistic evaluation.

There were 8 PONV cases in the study group against 18 cases in the control group. Fisher's exact test highlighted a p-value of P=0,03, marking the difference between the two groups as statistically significant.

Concluding, acupuncture presents a remarkable action against PONV after Laparoscopic Cholecystectomy (LPC). Another remarkable trait of acupuncture is the safety that it offers during application without provoking severe adverse effects. Furthermore, reduced medical costs thanks to decreased postoperative use of antiemetic medication, decreased patients' hospitalization, and reduced re-hospitalization possibility have to be noted. Finally, it has to be mentioned that despite LPC is in general terms painless, the analgesic effects of acupuncture should not be disregarded

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Male patients undergoing laparoscopic cholecystectomy regardless of other comorbidities.

• Adult Female patients undergoing laparoscopic cholecystectomy regardless of other comorbidities.

• To be able to communicate with personnel.

Exclusion Criteria:

• Patients under 18 years old.

• Inflammation of acupuncture site (PC6).

• Inaccessible acupuncture site (eg. arm amputees, trauma).

• Patients unable to communicate with personnel.

Related Conditions & MeSH terms

• Acupuncture
• Laparoscopic Cholecystectomy
• Nausea
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Vomiting
• Vomiting

Intervention

Device:
• Acupuncture Needles
Acupuncture Needles placement at the PC6 in association to anti-emetic medication

Drug:
• Antiemetic Drug
Administration of Anti-emetic medication without acupuncture

Locations

Country	Name	City	State
Greece	General Hospital of Rhodes	Rhodes	Dodekanese

Sponsors (1)

Lead Sponsor	Collaborator
University of West Attica

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients of the "acupuncture needles and antiemetic drug" group with postoperative nausea and vomit (PONV), versus the number of patients of the "antiemetic drug" group with PONV.		Immediately after surgery
Primary	The number of patients of the "acupuncture needles and antiemetic drug" group with postoperative nausea and vomit (PONV), versus the number of patients of the "antiemetic drug" group with PONV.		24 hours after surgery