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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pectus Excavatum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Acupressure (BioBand)

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Acupressure (BioBand)

Intervention Type DEVICE

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.

Interventions

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Acupressure (BioBand)

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

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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BioBand BioBand

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No