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

Not Applicable

Terminated

• Conditions: Pectus Excavatum
• Interventions: Device: Acupressure (BioBand)

• Registration Number: NCT00892216
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-04
• Primary Completion: 2010-01
• Study Completion: 2010-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Acupressure	Acupressure (BioBand)	The same band will be placed and turned so the beads face the corresponding point on the dorsal surface of the upper limb area.
Acupressure Band	Acupressure (BioBand)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Possibility of decrease in VAS score and hospital stay when compared to control group.	Day 5

Trial Locations

Locations (1)

McMaster University Hospital, HHSC/Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada