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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04759079
Enrollment
100
Registered
2021-02-18
Start date
2020-10-07
Completion date
2021-02-05
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea, Postoperative Vomiting, Laparoscopic Cholecystectomy, Acupuncture

Keywords

Acupuncture, Postoperative Nausea, Postoperative Vomiting, Laparoscopic Cholecystectomy

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

Interventions

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

Administration of Anti-emetic medication without acupuncture

Sponsors

University of West Attica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026