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

NCT00892216 | Terminated

• 1 other identifier: 05-188
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum

Keywords

PONV; NUSS procedure; Acupressure; Pectus Excavatum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Day 5

Study Arms (2)

Acupressure Band

EXPERIMENTAL

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)

Sham Acupressure

SHAM COMPARATOR

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)

Interventions

Acupressure (BioBand) DEVICE

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

Also known as: BioBand

Acupressure Band

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

McMaster University Hospital, HHSC/Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Funnel Chest; Postoperative Nausea and Vomiting

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

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

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 4, 2009
• Study Start: April 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CA (1)