The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy
Primary Purpose
Postoperative Nausea, Postoperative Vomiting, Laparoscopic Cholecystectomy
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Acupuncture Needles
Antiemetic Drug
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea focused on measuring Acupuncture, Postoperative Nausea, Postoperative Vomiting, Laparoscopic Cholecystectomy
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.
Sites / Locations
- General Hospital of Rhodes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acupuncture Needles and Antiemetic Drug
Antiemetic Drug
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04759079
First Posted
February 5, 2021
Last Updated
February 15, 2021
Sponsor
University of West Attica
1. Study Identification
Unique Protocol Identification Number
NCT04759079
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
February 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of West Attica
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea, Postoperative Vomiting, Laparoscopic Cholecystectomy, Acupuncture
Keywords
Acupuncture, Postoperative Nausea, Postoperative Vomiting, Laparoscopic Cholecystectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture Needles and Antiemetic Drug
Arm Type
Experimental
Arm Title
Antiemetic Drug
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Acupuncture Needles
Intervention Description
Acupuncture Needles placement at the PC6 in association to anti-emetic medication
Intervention Type
Drug
Intervention Name(s)
Antiemetic Drug
Intervention Description
Administration of Anti-emetic medication without acupuncture
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
General Hospital of Rhodes
City
Rhodes
State/Province
Dodekanese
ZIP/Postal Code
85133
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy
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