Breast Cancer Female
Conditions
Keywords
Mastectomy, Tissue expander, PEMF, PIB
Brief summary
This is a prospective randomized controlled double-blind interventional study comparing the effect of pulsed-electromagnetic field device (PEMF), pectoral interfascial block (PIB), and placebo on postoperative pain control. This study has the interdisciplinary cooperation of the regional anesthesia group, and the breast and plastic surgery divisions. All female patients with breast cancer evaluated at Columbia University Medical Center (CUMC) who are undergoing unilateral or bilateral mastectomy with tissue expander reconstruction will be offered enrollment in this prospective study.
Detailed description
Chronic pain after mastectomy, or breast tissue removal, is very common with almost half of women experiencing some type of residual pain and even 13% characterizing it as severe. Poor acute postoperative pain control is not only associated with development of chronic pain, but has also been shown to be associated with delayed wound healing. Therefore, optimization of postoperative pain control is paramount not just for patient comfort, but to decrease immediate and long-term postoperative complications. There are two adjunctive modes of perioperative pain control currently in use at Columbia University Medical Center (CUMC). The first mode uses pulsed electromagnetic fields (PEMF) and consists of a noninvasive device placed over dressings around the surgical site. The second is a regional anesthetic and -the pectoral interfascial block (PIB) in which a long-lasting local anesthetic (bupivacaine/ropivacaine) is injected into the surgical dissection area. Both of these techniques for postoperative analgesia have been shown to be effective in different types of breast surgery, but there is no current literature comparing the two modalities in their efficacy in reducing postoperative pain. There is also no current literature in their efficacy in the mastectomy and tissue expander patient population. The proposed trial is a prospective, randomized, controlled, double-blind trial to evaluate the efficacy of these two modalities of postoperative analgesia in patients undergoing mastectomy and tissue expander reconstruction.
Interventions
DRUGBupivacaine Hydrochloride
For active drug, 0.25% marcaine, will be used.
OTHERPlacebo Drug
For sham drug, 0.9% saline, will be used.
The pulsed electromagnetic field signal will consist of a 2-m sec burst of 27.12 megahertz (MHz) radiofrequency sinusoidal waves repeating at 2 bursts/second.
OTHERPlacebo Device
Sham devices will appear identical to and will be used in exactly the same manner as active devices but will produce no electromagnetic field.
For active drug, 0.25% naropin, will be used.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be female * Subjects must be 18 years or older * Subjects must be undergoing unilateral or bilateral mastectomy with tissue expander reconstruction
Exclusion criteria
* Allergy to all narcotic medications * Intake of any chronic opioids or pain medications preoperatively for a chronic condition or chronic use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention | 1 hour post-intervention | Pain level will be measured using the VAS scale. Subjects will rate their pain level on a scale of 0-10. Number 0 indicates no pain and number 10 indicates terrible pain. |
| Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention | 3 weeks post-intervention | Pain level will be measured using the VAS scale. Subjects will rate their pain level on a scale of 0-10. Number 0 indicates no pain and number 10 indicates terrible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention | 1 hour post-intervention | Quality of recovery will be measured using QoR. QoR is a 15-item self-reported questionnaire, with each response on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. The total score range is 0 to 150, with a higher score indicating a better quality of recovery. |
| Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention | 3 weeks post-intervention | Quality of recovery will be measured using QoR. QoR is a 15-item self-reported questionnaire, with each response on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. The total score range is 0 to 150, with a higher score indicating a better quality of recovery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active PEMF + Treatment PIB Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug: 0.25% Bupivacaine Hydrochloride or 0.25% Ropivacaine HCl. | 15 |
| Active PEMF + Sham PIB Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug: 0.9% saline. | 15 |
| Sham PEMF + Treatment PIB Participants will receive a placebo device (identical appearance to active device, but produces no electromagnetic field) and active drug: 0.25% Bupivacaine Hydrochloride. | 15 |
| Sham PEMF + Sham PIB Participants will receive placebo drug and placebo device. | 15 |
| Total | 60 |
Baseline characteristics
| Characteristic | Active PEMF + Treatment PIB | Total | Sham PEMF + Sham PIB | Sham PEMF + Treatment PIB | Active PEMF + Sham PIB |
|---|---|---|---|---|---|
| Age, Continuous | 50 years | 50 years | 53 years | 48 years | 53 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 23 Participants | 7 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 37 Participants | 8 Participants | 10 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 18 Participants | 6 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 31 Participants | 4 Participants | 8 Participants | 10 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 15 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 15 Participants | 60 Participants | 15 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 1 | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 14 | 0 / 1 | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 1 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention
Pain level will be measured using the VAS scale. Subjects will rate their pain level on a scale of 0-10. Number 0 indicates no pain and number 10 indicates terrible pain.
Time frame: 1 hour post-intervention
Population: 4 participants declined to do the VAS assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active PEMF + Treatment PIB | Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention | 6.64 score on a scale | Standard Deviation 2.76 |
| Active PEMF + Sham PIB | Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention | 6.67 score on a scale | Standard Deviation 2.29 |
| Sham PEMF + Treatment PIB | Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention | 4.62 score on a scale | Standard Deviation 3.57 |
| Sham PEMF + Sham PIB | Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention | 6.93 score on a scale | Standard Deviation 2.4 |
Primary
Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention
Pain level will be measured using the VAS scale. Subjects will rate their pain level on a scale of 0-10. Number 0 indicates no pain and number 10 indicates terrible pain.
Time frame: 3 weeks post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active PEMF + Treatment PIB | Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention | 2.53 score on a scale | Standard Deviation 2.07 |
| Active PEMF + Sham PIB | Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention | 2.00 score on a scale | Standard Deviation 2.2 |
| Sham PEMF + Treatment PIB | Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention | 2.00 score on a scale | Standard Deviation 1.89 |
| Sham PEMF + Sham PIB | Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention | 2.67 score on a scale | Standard Deviation 2.89 |
Secondary
Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention
Quality of recovery will be measured using QoR. QoR is a 15-item self-reported questionnaire, with each response on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. The total score range is 0 to 150, with a higher score indicating a better quality of recovery.
Time frame: 1 hour post-intervention
Population: Some participants in each arm declined to do the QoR assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active PEMF + Treatment PIB | Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention | 82.88 score on a scale | Standard Deviation 25.67 |
| Active PEMF + Sham PIB | Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention | 90.90 score on a scale | Standard Deviation 36.14 |
| Sham PEMF + Treatment PIB | Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention | 82.91 score on a scale | Standard Deviation 35.24 |
| Sham PEMF + Sham PIB | Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention | 77.50 score on a scale | Standard Deviation 16.84 |
Secondary
Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention
Quality of recovery will be measured using QoR. QoR is a 15-item self-reported questionnaire, with each response on a scale of 0-10 pertaining to patient's comfort, support system, pain, well being, and ability to carry out daily activities. The total score range is 0 to 150, with a higher score indicating a better quality of recovery.
Time frame: 3 weeks post-intervention
Population: 1 participant declined to do the QoR assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active PEMF + Treatment PIB | Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention | 122 score on a scale | Standard Deviation 23.79 |
| Active PEMF + Sham PIB | Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention | 123.27 score on a scale | Standard Deviation 18.77 |
| Sham PEMF + Treatment PIB | Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention | 125.93 score on a scale | Standard Deviation 20.29 |
| Sham PEMF + Sham PIB | Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention | 121 score on a scale | Standard Deviation 26.92 |