Cancer PainPhase 2NCT05328973
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
A Phase 2 study testing ELEQUIL in people with Cancer Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This is a prospective, controlled, randomized trial. Primary objective is to compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- ELEQUIL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 16 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years old)
- Port-a-Cath placement under Monitored Anesthesia Care
- Signed informed consent
Who cannot join
- Patients undergoing other surgical procedures during Port-a-Cath placement (including explantation of a Port-a-Cath or other previous vascular access device)
- Patients requiring general anesthesia or those not eligible for MAC
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, controlled, randomized trial. Primary objective is to compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. 70 Eligible subjects will be identified from within the patient population of the study site. There will be no advertisements for study subjects.
Read the detailed description
Primary Objective:
To compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo.
Secondary Objective:
To evaluate the following secondary outcomes:
- Anxiety score (HADS) in preoperative holding area
- Midazolam use intraoperatively (mg)
- Itraoperative opioid use (morphine equivalents)
- Intraoperative anti-emetic use
- Time to first occurrence of postoperative nausea or vomiting (PONV) in PACU
- Rate and intensity of PONV in PACU
- Antiemetic use in PACU
- Opioid use in PACU (morphine equivalents)
- Pain intensity in PACU (0-10 numerical rating scale)
- Patient satisfaction in PACU
- Conditions
- Cancer Pain
- Being tested
- ELEQUIL
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELEQUILOther
Also called Aromatabs
patch placed on skin
| Study group | Role | What they receive |
|---|---|---|
| ELEQUIL | Other | Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab. Receives: Other: ELEQUIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare the Time to Readiness for Discharge From PACU (Minutes) After Port-a-Cath Placement Surgery Between Patients Who Are Randomized to Receive Intraoperative Aromatherapy Versus Placebo
It measures the time to readiness for discharge from PACU (minutes) from PACU arrival to PACU discharge ready
Measured: from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average
Secondary outcomes (10)
Anxiety Score (HADS) in Preoperative Holding Area
The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that measures anxiety and depression. The HADS has 14 items, divided into two subscales of seven items each, and each item is scored on a 4-point Likert scale ranging from 0-3. Scores are interpreted as follows: 0-7: Normal 8-10: Borderline 11-21: Abnormal
Measured: From "In preop" to "Preop end" per EMR. 1hr in average
Midazolam Use Intraoperatively (mg)
The use on intravenous Midazolam in mg as per Anesthesia record.
Measured: From "Anesthesia Start" to "Anesthesia End". 1hr in average
Opioid Use Intraoperatively (in MEDD)
The use on intravenous opioids as per Anesthesia record, converted to MEDD (morphine milligram equivalent daily dose)
Measured: From "Anesthesia Start" to "Anesthesia End". 1hr in average
Intraoperative Anti-emetic Use
The use on intravenous Ondansetron in mg as per Anesthesia record.
Measured: From "Anesthesia Start" to "Anesthesia End". 1hr in average
Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU
Measured in assessments done at 1, 15, 30 minutes from PACU start. Patients were asked for nausea or vomiting.
Measured: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Rate and Intensity of PONV in PACU
Measured using the Verbal Numeric Rating Scale (0: no nausea and 10 worst nausea ever), patients were asked how would they rate their PONV.
Measured: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Anti-emetic Use in PACU
Number of Patients given antiemetic medication in PACU
Measured: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Opioid Use in PACU
Number of Patients given opioids in PACU
Measured: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Pain Intensity in PACU (0-10 Numerical Rating Scale)
Pain intensity reported by the patients during their stay in PACU, using the the numerical rating scale (NRS) 0 to 10, whereas 0 means no pain, and 10 means the worst possible pain.
Measured: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Patient Satisfaction in PACU
Rating the experience in PACU by the patients using the Likert Scale
Measured: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start18 May 2022
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Bailard, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328973
- Sponsor's protocol ID
- 2021-0994
- Other IDs
- NCI-2022-03112
- Status last verified
- Nov 2024
- First submitted
- 5 Apr 2022
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bailard N, Cukierman DS, Guerra-Londono JJ, Brown E, Hagberg C, Sauer A, Cata JP. Use of a Combination Lavender/Peppermint Aromatherapy Patch During Port Catheter Placement Under Monitored Anesthesia Care Does Not Reduce Time to Discharge Readiness: A Randomized Controlled Trial. J Integr Complement Med. 2024 Sep;30(9):840-847. doi: 10.1089/jicm.2023.0416. Epub 2024 Mar 19.
PubMed 38502819
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05328973
- Acronym / sponsor ID
- 2021-0994
- Conditions
- Cancer Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, controlled, randomized trial. Primary objective is to compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. 70 Eligible subjects will be identified from within the patient population of the study site. There will be no advertisements for study subjects.
Detailed description
Primary Objective:
To compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo.
Secondary Objective:
To evaluate the following secondary outcomes:
- Anxiety score (HADS) in preoperative holding area
- Midazolam use intraoperatively (mg)
- Itraoperative opioid use (morphine equivalents)
- Intraoperative anti-emetic use
- Time to first occurrence of postoperative nausea or vomiting (PONV) in PACU
- Rate and intensity of PONV in PACU
- Antiemetic use in PACU
- Opioid use in PACU (morphine equivalents)
- Pain intensity in PACU (0-10 numerical rating scale)
- Patient satisfaction in PACU
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELEQUIL | Other | Other: ELEQUILAromatherapy will be provided using a lavender-peppermint patch called an Aromatab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥ 18 years old)
- Port-a-Cath placement under Monitored Anesthesia Care
- Signed informed consent
Key exclusion criteria (2 listed)
- Patients undergoing other surgical procedures during Port-a-Cath placement (including explantation of a Port-a-Cath or other previous vascular access device)
- Patients requiring general anesthesia or those not eligible for MAC
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 |
|---|---|---|
| ELEQUILAlso: Aromatabspatch placed on skin | Other | ELEQUIL |
Primary outcome
To Compare the Time to Readiness for Discharge From PACU (Minutes) After Port-a-Cath Placement Surgery Between Patients Who Are Randomized to Receive Intraoperative Aromatherapy Versus Placebo
Time frame: from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average
It measures the time to readiness for discharge from PACU (minutes) from PACU arrival to PACU discharge ready
10 secondary outcomes
Anxiety Score (HADS) in Preoperative Holding Area
Time frame: From "In preop" to "Preop end" per EMR. 1hr in average
Midazolam Use Intraoperatively (mg)
Time frame: From "Anesthesia Start" to "Anesthesia End". 1hr in average
Opioid Use Intraoperatively (in MEDD)
Time frame: From "Anesthesia Start" to "Anesthesia End". 1hr in average
Intraoperative Anti-emetic Use
Time frame: From "Anesthesia Start" to "Anesthesia End". 1hr in average
Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU
Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Rate and Intensity of PONV in PACU
Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Anti-emetic Use in PACU
Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Opioid Use in PACU
Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Pain Intensity in PACU (0-10 Numerical Rating Scale)
Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Patient Satisfaction in PACU
Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38502819Bailard N, Cukierman DS, Guerra-Londono JJ, Brown E, Hagberg C, Sauer A, Cata JP. Use of a Combination Lavender/Peppermint Aromatherapy Patch During Port Catheter Placement Under Monitored Anesthesia Care Does Not Reduce Time to Discharge Readiness: A Randomized Controlled Trial. J Integr Complement Med. 2024 Sep;30(9):840-847. doi: 10.1089/jicm.2023.0416. Epub 2024 Mar 19.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Neil Bailard, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ELEQUIL in people with Cancer Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 2 Dec 2024. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Compare the Time to Readiness for Discharge From PACU (Minutes) After Port-a-Cath Placement Surgery Between Patients Who Are Randomized to Receive Intraoperative Aromatherapy Versus Placebo (time frame: from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05328973, which also lists 1 linked publication.
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 2 Dec 2024.