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

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy; Acupuncture; Postoperative Nausea; Postoperative Vomiting
• Intervention / Treatment: Device: Acupuncture Needles; Drug: Antiemetic Drug

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Dodekanese
    • Rhodes, Dodekanese, Greece, 85133
      • General Hospital of Rhodes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture Needles and Antiemetic Drug	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
Active Comparator: Antiemetic Drug	Drug: Antiemetic Drug; Administration of Anti-emetic medication without acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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
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

Collaborators and Investigators

• Sponsor: University of West Attica

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Acupuncture; Postoperative Nausea; Postoperative Vomiting; Laparoscopic Cholecystectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Antiemetics
• Other Study ID Numbers: 22917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No