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

Primary Purpose

Pectus Excavatum

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Acupressure (BioBand)

Acupressure (BioBand)

Sponsored by

McMaster University

About this trial

This is an interventional prevention trial for Pectus Excavatum focused on measuring PONV, NUSS procedure, Acupressure, Pectus Excavatum

Eligibility Criteria

8 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

McMaster University Hospital, HHSC/Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupressure Band

Sham Acupressure

Arm Description

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.

The same band will be placed and turned so the beads face the corresponding point on the dorsal surface of the upper limb area.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Possibility of decrease in VAS score and hospital stay when compared to control group.

Full Information

NCT ID

First Posted

April 30, 2009

Last Updated

April 7, 2015

Sponsor

McMaster University

Collaborators

Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00892216

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

Not enough participants for study to be completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pectus Excavatum

Keywords

PONV, NUSS procedure, Acupressure, Pectus Excavatum

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupressure Band

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham Acupressure

Arm Type

Sham Comparator

Arm Description

The same band will be placed and turned so the beads face the corresponding point on the dorsal surface of the upper limb area.

Intervention Type

Device

Intervention Name(s)

Acupressure (BioBand)

Other Intervention Name(s)

BioBand

Intervention Description

Band will remain on from 20 minutes before surgery until the end of the hospital stay.

Intervention Type

Device

Intervention Name(s)

Acupressure (BioBand)

Other Intervention Name(s)

BioBand

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Time Frame

Twice a day for 5 days

Secondary Outcome Measure Information:

Title

Possibility of decrease in VAS score and hospital stay when compared to control group.

Time Frame

Day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meena Nandagopal, M.B.B.S. DLO, DARCS, FFARCS(I)

Organizational Affiliation

Hamilton Health Sciences Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

McMaster University Hospital, HHSC/Hamilton Health Sciences

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

12. IPD Sharing Statement

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

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