Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.

NCT03088696 | Unknown

• 1 other identifier: Neiguan PC6
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of the effectiveness of PC 6 "Neiguan" with conventional acupuncture for preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.

Conditions

Cholecystitis; Vomiting; Nausea

Keywords

laparoscopic; acupuncture

Outcome Measures

Primary Outcomes (1)

• Vomiting and Nausea

  numeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive

  24 hours

Secondary Outcomes (2)

• Use of antiemetic

  24 hours

• Use of analgesia

  24 hours

Study Arms (2)

stimulation of the acupuncture point

ACTIVE COMPARATOR

a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"

Other: stimulation

no stimulation of the acupuncture point

PLACEBO COMPARATOR

only a bandage will be applied at pericardium channel 6, point "Neiguan"

Other: no stimulation

Interventions

stimulation OTHER

activation of the acupuncture point

stimulation of the acupuncture point

no stimulation OTHER

no activation of the acupuncture point

no stimulation of the acupuncture point

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male patients
• \> 18 y
• General anesthesia
• Undergoing laparoscopic surgery
• Patient with American Society of Anesthesiologists physical status I-II
• Written informed consent

You may not qualify if:

• Pregnant women and breastfeeding
• Patient with cardiac disease
• Surgery more than 2 h
• No bowel surgery
• Signs of skin infection at or near the purposed site of the acupuncture point
• Patient with American Society of Anesthesiologists physical status IIII-IV

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams-Brabant, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Cholecystitis; Vomiting; Nausea

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Poelaert, PhD MD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

• Güngör Badaş, Nurse

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Vincent Van Tittelboom, MD

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

• Philippe Bral, MD

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

Central Study Contacts

Veerle Van Mossevelde, Data Nurse

CONTACT

+3224763134; veerle.vanmossevelde@uzbrussel.be

Dirk De Clippeleir, Data Nurse

CONTACT

+324763580; dirk.declippeleir@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The care provider get's an envelope from the study nurse when going to the patient in the operating room. Only the study nurse knows if an acupuncture needle is in the envelope.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Data Nurse

Model Details: randomized comparative double blind prospective study

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 23, 2017
• Study Start: February 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)