Does Acupressure Decrease Post-operative Nausea and Vomiting (PONV) After the Pectus Excavatum Correction (NUSS) Procedure?

Does Acupressure Decrease Post-operative Nausea and Vomiting After the NUSS Procedure?

Post-operative nausea and vomiting (PONV) is not only unpleasant for patients but also can delay hospital discharge and increase cost of stay. In some cases, when severe vomiting occurs, pain scores seem to be increased. The overall incidence of PONV is 30% and increases to 79% in patients at high risk for this post-operative outcome. The NUSS procedure is considered to be a procedure with a high risk for the outcome of nausea and vomiting.

Study Overview

• Status: Terminated
• Conditions: Pectus Excavatum
• Intervention / Treatment: Device: Acupressure (BioBand); Device: Acupressure (BioBand)

Detailed Description

The rationale is to do a prospective study in patients who have been diagnosed with Pectus Excavatum and who are undergoing a NUSS procedure (pectus excavatum correction) and to evaluate the effect of Acupressure on the post-operative outcome of PONV in these patients. Also, to determine whether there are any secondary outcomes related to pain scores and length of hospital stay.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University Hospital, HHSC/Hamilton Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 8-40 years old
• ASA 1-3
• males & females

Exclusion Criteria:

• local infection of the site - P6
• acupuncture treatment within 8 weeks of the preoperative period
• coagulopathy is a contraindication for Acupuncture but not Acupressure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupressure Band; A band with bead attachment will be used to produce Acupressure and applied to the P6 (three fingers breath from the wrist crease on th ventral surface of the upper limb). The application will be done 20 minutes prior to anesthesia and explanation as to usage after surgery will be given. The patient of caregiver will apply pressure on the bead for three minutes and repeat this four times a day for the next five days. None of the protocol for prevention of PONV in this group of patients will be changed. The postoperative therapy for nausea and vomiting will be on a PRN (as required) basis. Nausea and vomiting scores and VAS scores for pain estimation will be carried out according to hospital protocol in the PACU amd twice a day thereafter for their period of stay in the hospital. The amount of analgesics and antiemetics used and the number of days spent in the hospital will be registered.	Device: Acupressure (BioBand); Band will remain on from 20 minutes before surgery until the end of the hospital stay.; Other Names: BioBand; Device: Acupressure (BioBand); Band will remain on from 20 minutes before surgery until the end of the hospital stay. The same band will be placed and turned so the beads face the corresponding point on the dorsal surface of the upper limb area.; Other Names: BioBand
Sham Comparator: Sham Acupressure; The same band will be placed and turned so the beads face the corresponding point on the dorsal surface of the upper limb area.	Device: Acupressure (BioBand); Band will remain on from 20 minutes before surgery until the end of the hospital stay.; Other Names: BioBand; Device: Acupressure (BioBand); Band will remain on from 20 minutes before surgery until the end of the hospital stay. The same band will be placed and turned so the beads face the corresponding point on the dorsal surface of the upper limb area.; Other Names: BioBand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relief of PONV. This effect will be evaluated in the PACU and then twice a day until discharge which is usually 5 days post-operative. Hospital score for nausea and vomiting will be used.	Twice a day for 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Possibility of decrease in VAS score and hospital stay when compared to control group.	Day 5

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Meena Nandagopal, M.B.B.S. DLO, DARCS, FFARCS(I), Hamilton Health Sciences Corporation

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: April 30, 2009
• First Submitted That Met QC Criteria: May 1, 2009
• First Posted (Estimate): May 4, 2009

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Acupressure; PONV; Pectus Excavatum; NUSS procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Congenital Abnormalities; Signs and Symptoms, Digestive; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Nausea; Vomiting; Postoperative Nausea and Vomiting; Funnel Chest
• Other Study ID Numbers: 05-188