Pectus ExcavatumNCT00892216
Does Acupressure Decrease Post-operative Nausea and Vomiting (PONV) After the Pectus Excavatum Correction (NUSS) Procedure?
A study testing Acupressure (BioBand) in people with Pectus Excavatum, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 40 years
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Acupressure (BioBand)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 8-40 years old
- ASA 1-3
- males \& females
Who cannot join
- local infection of the site - P6
- acupuncture treatment within 8 weeks of the preoperative period
- coagulopathy is a contraindication for Acupuncture but not Acupressure
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster University Hospital, HHSC/Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
About this study
Official title: 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.
Read the 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.
- Conditions
- Pectus Excavatum
- Being tested
- Acupressure (BioBand)
- Keywords
- PONV, NUSS procedure, Acupressure, Pectus Excavatum
- Medical subject headings
- Funnel Chest, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure (BioBand)Device
Also called BioBand
Band will remain on from 20 minutes before surgery until the end of the hospital stay.
Acupressure (BioBand)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Acupressure (BioBand) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twice a day for 5 days
Secondary outcomes (1)
Possibility of decrease in VAS score and hospital stay when compared to control group.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startApr 2005
- Primary completionJan 2010
- Study completionOct 2010
Why it stopped: Not enough participants for study to be completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Meena Nandagopal, M.B.B.S. DLO, DARCS, FFARCS(I), Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892216
- Sponsor's protocol ID
- 05-188
- Status last verified
- Apr 2015
- First submitted
- 30 Apr 2009
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Acupressure Decrease Post-operative Nausea and Vomiting After the NUSS Procedure?
- ClinicalTrials.gov ID
- NCT00892216
- Acronym / sponsor ID
- 05-188
- Conditions
- Pectus Excavatum
- Keywords
- PONV, NUSS procedure, Acupressure, Pectus Excavatum
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough participants for study to be completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- Apr 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure Band | Experimental | Device: 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. |
| Sham Acupressure | Sham comparator | Device: 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. |
Who may qualify
- Ages
- 8 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 8-40 years old
- ASA 1-3
- males \& females
Key exclusion criteria (3 listed)
- local infection of the site - P6
- acupuncture treatment within 8 weeks of the preoperative period
- coagulopathy is a contraindication for Acupuncture but not Acupressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure (BioBand)Also: BioBandBand will remain on from 20 minutes before surgery until the end of the hospital stay. | Device | Acupressure Band |
| Acupressure (BioBand)Also: BioBandBand 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. | Device | Sham Acupressure |
Primary outcome
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
1 secondary outcome
Possibility of decrease in VAS score and hospital stay when compared to control group.
Time frame: Day 5
Results and safety
The study was stopped early (reason given: Not enough participants for study to be completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meena Nandagopal, M.B.B.S. DLO, DARCS, FFARCS(I) principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure (BioBand) in people with Pectus Excavatum, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough participants for study to be completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.