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OpenTrials
Completed

NCT Number: NCT04759079

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Rhodes

Rhodes, Dodekanese, 85133, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture needles

Device

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

Antiemetic Drug

Drug

Administration of Anti-emetic medication without acupuncture

Primary outcomes

  1. 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.

    Time frame: Immediately after surgery

  2. 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.

    Time frame: 24 hours after surgery

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2021
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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