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

NCT04759079 | Completed

• 1 other identifier: 22917
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Nausea; Postoperative Vomiting; Laparoscopic Cholecystectomy; Acupuncture

Keywords

Acupuncture; Postoperative Nausea; Postoperative Vomiting; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

Acupuncture Needles and Antiemetic Drug

EXPERIMENTAL

Device: Acupuncture Needles; Drug: Antiemetic Drug

Antiemetic Drug

ACTIVE COMPARATOR

Drug: Antiemetic Drug

Interventions

Acupuncture Needles DEVICE

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

Acupuncture Needles and Antiemetic Drug

Antiemetic Drug DRUG

Administration of Anti-emetic medication without acupuncture

Acupuncture Needles and Antiemetic Drug; Antiemetic Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients under 18 years old.
• Inflammation of acupuncture site (PC6).
• Inaccessible acupuncture site (eg. arm amputees, trauma).
• Patients unable to communicate with personnel.

Sponsors & Collaborators

• University of West Attica: lead

Study Sites (1)

General Hospital of Rhodes

Rhodes, Dodekanese, 85133, Greece

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Antiemetics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 18, 2021
• Study Start: October 7, 2020
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)