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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active PEMF + Treatment PIB | Other | Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl). |
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| Active PEMF + Sham PIB | Other | Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug. |
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| Sham PEMF + Treatment PIB | Other | Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl). |
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| Sham PEMF + Sham PIB | Other | Participants will receive placebo drug and placebo device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | For active drug, 0.25% marcaine, will be used. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour post-intervention |
| 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. | 3 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Rohde, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active PEMF + Treatment PIB | Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl). Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used. Pulsed Electromagnetic Field (PEMF) Device: 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. Ropivacaine Hydrochloride: For active drug, 0.25% naropin, will be used. |
| FG001 | Active PEMF + Sham PIB | Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug. Placebo Drug: For sham drug, 0.9% saline, will be used. Pulsed Electromagnetic Field (PEMF) Device: 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. |
| FG002 | Sham PEMF + Treatment PIB | Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride). Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used. Placebo 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. |
| FG003 | Sham PEMF + Sham PIB | Participants will receive placebo drug and placebo device. Placebo Drug: For sham drug, 0.9% saline, will be used. Placebo 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Active PEMF + Sham PIB |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 4 participants declined to do the VAS assessment. | Posted | Mean | Standard Deviation | score on a scale | 1 hour post-intervention |
|
Up to 3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active PEMF + Bupivacaine Hydrochloride | Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug: 0.25% Bupivacaine Hydrochloride. |
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Due to drug shortage, Ropivacaine was used in place of Bupivacaine in 1 participant. Bupivacaine and Ropivacaine are FDA-approved local anesthetics currently used in pectoral interfascial blocks for breast surgery patients. Bupivacaine and Ropivacaine are both long-acting local anesthetics with a similar mechanism of action.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherene Ishtihar | Columbia University | 212-342-3681 | si2271@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2021 | Feb 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo Drug | Other | For sham drug, 0.9% saline, will be used. |
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| Pulsed Electromagnetic Field (PEMF) Device | Device | 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. |
|
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| Placebo Device | Other | Sham devices will appear identical to and will be used in exactly the same manner as active devices but will produce no electromagnetic field. |
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| Ropivacaine Hydrochloride | Drug | For active drug, 0.25% naropin, will be used. |
|
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| 1 hour post-intervention |
| 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. | 3 weeks post-intervention |
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug: 0.9% saline.
| BG002 | 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. |
| BG003 | Sham PEMF + Sham PIB | Participants will receive placebo drug and placebo device. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Active PEMF + Sham PIB | Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug. Placebo Drug: For sham drug, 0.9% saline, will be used. Pulsed Electromagnetic Field (PEMF) Device: 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. |
| OG002 | Sham PEMF + Treatment PIB | Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride). Bupivacaine Hydrochloride: For active drug, 0.25% marcaine, will be used. Placebo 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. |
| OG003 | Sham PEMF + Sham PIB | Participants will receive placebo drug and placebo device. Placebo Drug: For sham drug, 0.9% saline, will be used. Placebo 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. |
|
|
| 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. | Some participants in each arm declined to do the QoR assessment. | Posted | Mean | Standard Deviation | score on a scale | 1 hour post-intervention |
|
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| 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. | 1 participant declined to do the QoR assessment. | Posted | Mean | Standard Deviation | score on a scale | 3 weeks post-intervention |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 weeks post-intervention |
|
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|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Active PEMF + Ropivacaine HCl | Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug: 0.25% Ropivacaine HCl. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Active PEMF + Placebo | Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug: 0.9% saline. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Sham PEMF + Bupivacaine Hydrochloride | Participants will receive a placebo device (identical appearance to active device, but produces no electromagnetic field) and active drug: 0.25% Bupivacaine Hydrochloride. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG004 | Sham PEMF + Placebo | Participants will receive placebo drug and placebo device. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |