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

Sponsor

University of West Attica (Other)

Overall Status

Completed

CT.gov ID

NCT04759079

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

25.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea Postoperative Vomiting Laparoscopic Cholecystectomy Acupuncture	Device: Acupuncture Needles Drug: Antiemetic Drug	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 7, 2020

Actual Primary Completion Date :

Feb 5, 2021

Actual Study Completion Date :

Feb 5, 2021

Arms and Interventions

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

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

Outcome Measures

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. [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.