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

NCT04759079 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-18

No results posted yet for this study

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

Conditions

  • Postoperative Nausea
  • Postoperative Vomiting
  • Laparoscopic Cholecystectomy
  • Acupuncture

Interventions

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

Sponsors & Collaborators

  • University of West Attica

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2021-02-05
Completion
2021-02-05

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759079 on ClinicalTrials.gov