Clinical trial NCT04759079: The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy
Official title: The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea
Postoperative Vomiting
Laparoscopic Cholecystectomy
Acupuncture
Keywords: Acupuncture
Postoperative Nausea
Postoperative Vomiting
Laparoscopic Cholecystectomy
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Immediately after surgery
measure: 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.
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rhodes
country: Greece
facility: General Hospital of Rhodes
state: Dodekanese
Study officials:
References: