A Phase 4 interventional study of Bupivacaine Hydrochloride and Placebo Drug in Breast Cancer Female, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Columbia University · Phase 4, Interventional, and Treatment
Among 22 studies testing bupivacaine in Breast Neoplasms — none open to participants now, 1 under way, 1 of them phase 3. Bupivacaine · Breast Neoplasms.
Among the 22 studies testing bupivacaine in Breast Neoplasms, this one is the 10th largest by enrollment, is one of 4 that started in 2017, is one of 2 in phase 4, and was the 11th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →None of the 22 studies testing bupivacaine in Breast Neoplasms is open now.
Bupivacaine: first FDA approval 1972 (MARCAINE HYDROCHLORIDE PRESERVATIVE FREE), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 4 started in 2017.
Median enrollment 60 across the 22 interventional studies. Of the 15 that completed or were terminated, 6 (40%) have results posted.
None of the 22 has an industry lead sponsor. The 10 most frequent:
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
38 studies in Breast Neoplasms by Columbia University: 8 open now, 9 under way, none of them phase 3. Of 28 finished, 10 (36%) have results posted.
Among the 38 studies in Breast Neoplasms by Columbia University, this one is the 14th largest by enrollment of the 37 interventional ones, is one of 4 that started in 2017, is the only one in phase 4, and was the 24th registered.
Columbia University’s Breast Neoplasms studies by the year they started, since 2005.
1 of the studies testing bupivacaine in Breast Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03351348Phase 3Memorial Sloan Kettering Cancer CenterBupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control | 2027-11 |
Among the 22 studies testing bupivacaine in Breast Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Columbia University’s 38 in Breast Neoplasms:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Drug: Bupivacaine Hydrochloride · Device: Pulsed Electromagnetic Field (PEMF) Device · Drug: Ropivacaine Hydrochloride
Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.
Other: Placebo Drug · Device: Pulsed Electromagnetic Field (PEMF) Device
Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).
Drug: Bupivacaine Hydrochloride · Other: Placebo Device · Drug: Ropivacaine Hydrochloride
Participants will receive placebo drug and placebo device.
Other: Placebo Drug · Other: Placebo Device
For active drug, 0.25% marcaine, will be used.
Also known as: Marcaine, PIB
For sham drug, 0.9% saline, will be used.
Also known as: Saline
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.
Also known as: Sofpulse, Torino II
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.
Also known as: Naropin, PIB
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
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
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
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
| Milestone | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB |
|---|---|---|---|---|
| Started | 15 | 15 | 15 | 15 |
| Completed | 15 | 15 | 15 | 15 |
| Not completed | 0 | 0 | 0 | 0 |
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 a scale | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB |
|---|---|---|---|---|
| Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention | 6.64 ± 2.76 | 6.67 ± 2.29 | 4.62 ± 3.57 | 6.93 ± 2.4 |
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.
| score on a scale | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB |
|---|---|---|---|---|
| Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention | 82.88 ± 25.67 | 90.90 ± 36.14 | 82.91 ± 35.24 | 77.50 ± 16.84 |
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.
| score on a scale | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB |
|---|---|---|---|---|
| Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention | 122 ± 23.79 | 123.27 ± 18.77 | 125.93 ± 20.29 | 121 ± 26.92 |
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 a scale | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB |
|---|---|---|---|---|
| Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention | 2.53 ± 2.07 | 2.00 ± 2.20 | 2.00 ± 1.89 | 2.67 ± 2.89 |
Collected over Up to 3 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active PEMF + Bupivacaine Hydrochloride | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Active PEMF + Ropivacaine HCl | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Active PEMF + Placebo | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Sham PEMF + Bupivacaine Hydrochloride | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Sham PEMF + Placebo | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB | Total |
|---|---|---|---|---|---|
| Median | 50 (32 to 68) | 53 (31 to 64) | 48 (33 to 69) | 53 (36 to 60) | 50 (31 to 69) |
| Sex: Female, Male(Participants) | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB | Total |
|---|---|---|---|---|---|
| Female | 15 | 15 | 15 | 15 | 60 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 5 | 7 | 23 |
| Not Hispanic or Latino | 10 | 9 | 10 | 8 | 37 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 0 | 3 | 3 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 4 | 6 | 18 |
| White | 9 | 10 | 8 | 4 | 31 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 0 | 2 | 3 |
| Region of Enrollment(participants) | Active PEMF + Treatment PIB | Active PEMF + Sham PIB | Sham PEMF + Treatment PIB | Sham PEMF + Sham PIB | Total |
|---|---|---|---|---|---|
| United States | 15 | 15 | 15 | 15 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drugs tested here: Bupivacaine · Ropivacaine