Cancer Pain
Conditions
Brief 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. 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
Interventions
OTHERELEQUIL
patch placed on skin
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥ 18 years old) * Port-a-Cath placement under Monitored Anesthesia Care * Signed informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Midazolam Use Intraoperatively (mg) | From Anesthesia Start to Anesthesia End. 1hr in average | The use on intravenous Midazolam in mg as per Anesthesia record. |
| Opioid Use Intraoperatively (in MEDD) | From Anesthesia Start to Anesthesia End. 1hr in average | The use on intravenous opioids as per Anesthesia record, converted to MEDD (morphine milligram equivalent daily dose) |
| Intraoperative Anti-emetic Use | From Anesthesia Start to Anesthesia End. 1hr in average | The use on intravenous Ondansetron in mg as per Anesthesia record. |
| Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU | From PACU Start to PACU Discharge, 1.5 hr in average | Measured in assessments done at 1, 15, 30 minutes from PACU start. Patients were asked for nausea or vomiting. |
| Anxiety Score (HADS) in Preoperative Holding Area | From In preop to Preop end per EMR. 1hr in average | 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 |
| Anti-emetic Use in PACU | From PACU Start to PACU Discharge, 1.5 hr in average | Number of Patients given antiemetic medication in PACU |
| Opioid Use in PACU | From PACU Start to PACU Discharge, 1.5 hr in average | Number of Patients given opioids in PACU |
| Pain Intensity in PACU (0-10 Numerical Rating Scale) | From PACU Start to PACU Discharge, 1.5 hr in average | 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. |
| Patient Satisfaction in PACU | From PACU Start to PACU Discharge, 1.5 hr in average | Rating the experience in PACU by the patients using the Likert Scale |
| Rate and Intensity of PONV in PACU | From PACU Start to PACU Discharge, 1.5 hr in average | Measured using the Verbal Numeric Rating Scale (0: no nausea and 10 worst nausea ever), patients were asked how would they rate their PONV. |
Countries
United States
Participant flow
Recruitment details
This study enrolled 70 patients between May 2022 and March 2023. Eligible subjects were identified from within the patient population of the study site by members of the research team.
Participants by arm
| Arm | Count |
|---|---|
| Elequis Aromatab (Lavander/Pepermint) Elequis Aromatab was placed next to patient's pillow | 35 |
| Placebo Placebo tab was placed next to patient's pillow | 35 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Elequis Aromatab (Lavander/Pepermint) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 52.4 Years STANDARD_DEVIATION 13.225 | 52.886 Years STANDARD_DEVIATION 15.212 | 52.64 Years STANDARD_DEVIATION 14.15 |
| ASA 2 | 3 Participants | 0 Participants | 3 Participants |
| ASA 3 | 32 Participants | 35 Participants | 67 Participants |
| BMI <=25 | 13 Participants | 13 Participants | 26 Participants |
| BMI >25 | 22 Participants | 22 Participants | 44 Participants |
| Charlson Score 0 | 1 Participants | 3 Participants | 4 Participants |
| Charlson Score 1 to 2 | 8 Participants | 11 Participants | 19 Participants |
| Charlson Score 3 to 4 | 15 Participants | 6 Participants | 21 Participants |
| Charlson Score >=5 | 11 Participants | 15 Participants | 26 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 28 Participants | 26 Participants | 54 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 1 / 35 | 3 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
Primary
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
Time frame: from PACU arrival to PACU discharge ready, 1.5 hrs in average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | 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 | 82.057 Minutes | Standard Deviation 15.376 |
| Placebo | 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 | 89.382 Minutes | Standard Deviation 21.25 |
Secondary
Anti-emetic Use in PACU
Number of Patients given antiemetic medication in PACU
Time frame: From PACU Start to PACU Discharge, 1.5 hr in average
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Anti-emetic Use in PACU | 0 Participants |
| Placebo | Anti-emetic Use in PACU | 1 Participants |
Secondary
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
Time frame: From In preop to Preop end per EMR. 1hr in average
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Anxiety Score (HADS) in Preoperative Holding Area | Normal | 31 Participants |
| Elequis Aromatab (Lavander/Pepermint) | Anxiety Score (HADS) in Preoperative Holding Area | Abnormal | 1 Participants |
| Elequis Aromatab (Lavander/Pepermint) | Anxiety Score (HADS) in Preoperative Holding Area | Borderline | 3 Participants |
| Placebo | Anxiety Score (HADS) in Preoperative Holding Area | Borderline | 3 Participants |
| Placebo | Anxiety Score (HADS) in Preoperative Holding Area | Normal | 29 Participants |
| Placebo | Anxiety Score (HADS) in Preoperative Holding Area | Abnormal | 2 Participants |
Secondary
Intraoperative Anti-emetic Use
The use on intravenous Ondansetron in mg as per Anesthesia record.
Time frame: From Anesthesia Start to Anesthesia End. 1hr in average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Intraoperative Anti-emetic Use | 4 mg | Standard Deviation 0.97 |
| Placebo | Intraoperative Anti-emetic Use | 3.41 mg | Standard Deviation 1.43 |
Secondary
Midazolam Use Intraoperatively (mg)
The use on intravenous Midazolam in mg as per Anesthesia record.
Time frame: From Anesthesia Start to Anesthesia End. 1hr in average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Midazolam Use Intraoperatively (mg) | 3.63 mg | Standard Deviation 1.28 |
| Placebo | Midazolam Use Intraoperatively (mg) | 3.6 mg | Standard Deviation 1.5 |
Secondary
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.
Time frame: From PACU Start to PACU Discharge, 1.5 hr in average
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU | 0 Participants |
| Placebo | Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU | 1 Participants |
Secondary
Opioid Use in PACU
Number of Patients given opioids in PACU
Time frame: From PACU Start to PACU Discharge, 1.5 hr in average
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Opioid Use in PACU | 2 Participants |
| Placebo | Opioid Use in PACU | 3 Participants |
Secondary
Opioid Use Intraoperatively (in MEDD)
The use on intravenous opioids as per Anesthesia record, converted to MEDD (morphine milligram equivalent daily dose)
Time frame: From Anesthesia Start to Anesthesia End. 1hr in average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Opioid Use Intraoperatively (in MEDD) | 2.59 MEDD | Standard Deviation 1.05 |
| Placebo | Opioid Use Intraoperatively (in MEDD) | 2.91 MEDD | Standard Deviation 1.5 |
Secondary
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.
Time frame: From PACU Start to PACU Discharge, 1.5 hr in average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Pain Intensity in PACU (0-10 Numerical Rating Scale) | 0.3257 score on a scale | Standard Deviation 1.0371 |
| Placebo | Pain Intensity in PACU (0-10 Numerical Rating Scale) | 0.5429 score on a scale | Standard Deviation 1.0661 |
Secondary
Patient Satisfaction in PACU
Rating the experience in PACU by the patients using the Likert Scale
Time frame: From PACU Start to PACU Discharge, 1.5 hr in average
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Patient Satisfaction in PACU | Unknown | 0 Participants |
| Elequis Aromatab (Lavander/Pepermint) | Patient Satisfaction in PACU | Somewhat satisfied | 0 Participants |
| Elequis Aromatab (Lavander/Pepermint) | Patient Satisfaction in PACU | Very much satisfied | 35 Participants |
| Placebo | Patient Satisfaction in PACU | Somewhat satisfied | 2 Participants |
| Placebo | Patient Satisfaction in PACU | Unknown | 0 Participants |
| Placebo | Patient Satisfaction in PACU | Very much satisfied | 32 Participants |
Secondary
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.
Time frame: From PACU Start to PACU Discharge, 1.5 hr in average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elequis Aromatab (Lavander/Pepermint) | Rate and Intensity of PONV in PACU | 0 score on a scale | Standard Deviation 0 |
| Placebo | Rate and Intensity of PONV in PACU | 0.0118 score on a scale | Standard Deviation 0.0686 |