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

NCT ID: NCT04759079

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2021-02-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Acupuncture Needles and Antiemetic Drug

Group Type: EXPERIMENTAL

Acupuncture Needles

Intervention Type: DEVICE

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

Antiemetic Drug

Intervention Type: DRUG

Administration of Anti-emetic medication without acupuncture

Antiemetic Drug

Group Type: ACTIVE_COMPARATOR

Antiemetic Drug

Intervention Type: DRUG

Administration of Anti-emetic medication without acupuncture

Interventions

Acupuncture Needles

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

Intervention Type: DEVICE

Antiemetic Drug

Administration of Anti-emetic medication without acupuncture

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of West Attica

OTHER

Sponsor Role: lead

Responsible Party

Theofilos Tsoleridis MD, MA, MSc, PgDip(c), PhD(c)

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Hospital of Rhodes

Rhodes, Dodekanese, Greece

Countries

Greece

Other Identifiers

22917

Identifier Type: -

Identifier Source: org_study_id