Trial · NCT02473042
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
NCT02473042, Not applicable, Completed, M.D. Anderson Cancer Center; results first posted 2025-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV). Trials, record NCT02473042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02473042
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
- NCT number
- NCT02473042
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 188 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Post-Operative Nausea and Vomiting, Breast Cancer
- Interventions
- Electrical Stimulation, Zofran, Dexamethasone, Phenergan, Pepcid, Questionnaire
- First posted
- 2015-06-16
- Last updated
- 2025-12-05
- Results first posted
- 2025-12-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day | Examine the efficacy of electrical stimulation of P6 combined with prophylactic anti-emetics versus pharmacological prophylaxis alone in preventing the incidence of PONV following breast surgery in patients at high-risk for PONV Complete control is defined as "No nausea≥3 \& No vomiting \& No use of anti-emetic during PACU stay" |
| Secondary | Feasibility of Conducting Study | At study consent and at PACU discharge | Determine the study feasibility where feasibility is defined by at least 20% of screened patients meeting inclusion criteria ability, 50% of these patients consenting, and 75% of patients within the acupuncture study arm completing all procedures |
| Secondary | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day | Examine the effects of intra-operative NMBM stimulation of P6 on whether or not any anti-emetics were used compared to the control group |
| Secondary | Satisfaction | At discharge from post-operative anesthesia care unit | Examine group differences in post-operative patient satisfaction with PONV management. Participants were asked to rate their satisfaction with their nausea and vomiting management on a scale of 0-10, where "0" equals "very dissatisfied", and "10" equals "extremely satisfied". |
| Secondary | Efficacy of Intervention to Result in Decreased PACU Length-of-stay | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day | Explore if intra-operative NMBM stimulation of P6 results in decreased PACU length-of-stay |
| Secondary | Expectancy | Baseline | Explore the associations between expectancy and response to P6 stimulation. Step 1 of 2 compares expectancy answers between groups. The expectancy questionnaire asks participants what their expectation is of the effects of the intervention on lowering their nausea after surgery, lowering their pain after surgery, enabling them to cope with nausea and/or pain better, and enabling them to have a better recovery after surgery. Possible answers are "Not at all agree", "A little agree", "Moderately agree", "Mostly agree", and "Completely agree". |
| Secondary | Expectancy and Response to P6 Stimulation | During stay in post-operative anesthesia care unit, until discharge | Explore the associations between expectancy and response to P6 stimulation. Step 2 of 2 compares baseline expectancy answers and response to P6 stimulation outcome directly, without taking into account group assignment. The P6 stimulation outcome was categorized as "Fail" or "Success", where "Success" is defined as "No nausea≥3 \& No vomiting \& No use of anti-emetic during PACU stay". |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Feasibility of Conducting Study | At study consent and at PACU discharge | Feasibility was defined in three different ways, and in accordance with each feasibility definition type, there was a different number of patients analyzed. Per protocol, for the completed study feasibility definition, we were only looking at the intervention arm. We were not looking at both arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day | Number of participants analyzed does not match number of participants who completed in participant flow due to missing data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Satisfaction | At discharge from post-operative anesthesia care unit | Number of participants analyzed does not match number of participants who completed in participant flow due to missing data | Satisfaction score | MEAN |
| SECONDARY | Efficacy of Intervention to Result in Decreased PACU Length-of-stay | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day | number of minutes | MEAN | |
| SECONDARY | Expectancy | Baseline | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Expectancy and Response to P6 Stimulation | During stay in post-operative anesthesia care unit, until discharge | The statistical analysis was between expectancy response at baseline and response to P6 stimulation outcome of either fail or success during PACU stay until discharge, regardless of group assignment. Number of participants analyzed does not match number of participants who completed in participant flow due to missing data for the P6 stimulation outcome. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group89
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Intervention | Fail | 19 | Participants | |
| Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Control | Fail | 12 | Participants | |
| Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Intervention | Success | 67 | Participants | |
| Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Control | Success | 71 | Participants | |
| Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Intervention | Missing Information | 0 | Participants | |
| Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Control | Missing Information | 3 | Participants | |
| Feasibility of Conducting Study | Entire Study | Screened eligible | 233 | Participants | |
| Feasibility of Conducting Study | Entire Study | Consented | 188 | Participants | |
| Feasibility of Conducting Study | Entire Study | Completed study | 86 | Participants | |
| Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | Intervention | No | 45 | Participants |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention | 92 | |
| Overall Study | STARTED | Control | 92 | |
| Overall Study | COMPLETED | Intervention | 86 | |
| Overall Study | COMPLETED | Control | 86 | |
| Overall Study | NOT COMPLETED | Intervention | 6 | |
| Overall Study | NOT COMPLETED | Control | 6 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Muscle weakness upper limb [left] | Musculoskeletal and connective tissue disorders | Intervention | 1 | 86 | |
| other | Muscle weakness upper limb [left] | Musculoskeletal and connective tissue disorders | Control | 2 | 86 | |
| other | Muscle weakness upper limb [right] | Musculoskeletal and connective tissue disorders | Intervention | 0 | 86 | |
| other | Muscle weakness upper limb [right] | Musculoskeletal and connective tissue disorders | Control | 3 | 86 | |
| other | Numbness in left arm | Nervous system disorders | Intervention | 1 | 86 | |
| other | Numbness in left arm | Nervous system disorders | Control | 2 | 86 | |
| other | Numbness in right arm | Nervous system disorders | Intervention | 0 | 86 | |
| other | Numbness in right arm | Nervous system disorders | Control | 1 | 86 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Intervention | 0 | 86 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Control | 1 | 86 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention | 0 | 86 |
| Total, all-cause mortality | Control | 0 | 86 |
| Total, other adverse events | Intervention | 4 | 86 |
| Total, other adverse events | Control | 11 | 86 |
| Total, serious adverse events | Intervention | 0 | 86 |
| Total, serious adverse events | Control | 0 | 86 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention vs Control: deaths from any cause | Trial comparisons |
| Intervention vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02473042
GET https://conductscience.org/api/trials/v1/NCT02473042/results?page=2