Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759079
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2021-02-05
Brief Title:
The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy
Sponsor:
University of West Attica
Organization:
University of West Attica
Study Overview
Official Title:
The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients medical history In the study group after anesthesia induction and before pneumoperitoneum application a sterile stainless steel 025 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 Fishers exact test was chosen for statistic evaluation
There were 8 PONV cases in the study group against 18 cases in the control group Fishers exact test highlighted a p-value of P003 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
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 patients medical history In the study group after anesthesia induction and before pneumoperitoneum application a sterile stainless steel 025 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 Fishers exact test was chosen for statistic evaluation
There were 8 PONV cases in the study group against 18 cases in the control group Fishers exact test highlighted a p-value of P003 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None