Comparing pain relief methods after breast surgery: a study on new and traditional approaches
| ISRCTN | ISRCTN85101944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85101944 |
| Secondary identifying numbers | 1967230-3 |
- Submission date
- 12/10/2024
- Registration date
- 15/10/2024
- Last edited
- 15/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
There is currently inconclusive evidence on whether liposomal bupivacaine plus bupivacaine hydrochloride (LB-BH) confers better post-lumpectomy analgesia than standard bupivacaine hydrochloride (BH). This study aimed to compare patient-reported pain control and clinical outcomes.
Who can participate?
Any patients who are able to consent over age 18 who undergoing only lumpectomies of their breast for any reasons.
What does the study involve?
Receiving LB-BH injection prior to the incision or BH alone and watch for pain management on that side
What are the possible benefits and risks of participating?
Same benefit of analgesia but 20-30 times less money and no narcotics sent home with, so helping with opioid epidemics
Where is the study run from?
University of Michigan Health-Sparrow (USA)
When is the study starting and how long is it expected to run for?
February 2023 to February 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Irada Mamukadze, irada.mamukadze@umhsparrow.org
Contact information
Scientific, Principal Investigator
1215 E. Michigan ave
Lansing
48912
United States of America
| Phone | +1 9372191095 |
|---|---|
| thais.fortes@umhsparrow.org |
Public, Scientific
935 Whittier Dr
East Lansing
48823
United States of America
 ORCID ID |
0009-0005-0865-0926 |
|---|---|
| Phone | +1 9372191095 |
| Irada.Mamukadze@umhsparrow.org |
Study information
| Study design | Single-center patient-blinded prospective randomized controlled trial who undergo lumpectomy |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Comparing post-lumpectomy analgesia using enhanced recovery after surgery (ERAS) protocol with and without liposomal bupivacaine: randomized controlled trial |
| Study acronym | ERAS |
| Study objectives | Liposomal Bupivacaine and Bupivacaine hydrochloride have same efficacy on pain control |
| Ethics approval(s) |
Approved 15/02/2024, Sparrow Health System IRB (1215 Michigan Avenue, Lansing, MI, 48912, United States of America; +1 5173645016; irb@sparrow.org), ref: 2228 |
| Health condition(s) or problem(s) studied | Use of bupivacaine hydrochloride during lumpectomy surgery |
| Intervention | Patients were randomized in a 1:1 ratio to either the intervention group Bupivacaine Liposomal with Bupivacaine Hydrochloride (LB-BH) or Bupivacaine Hydrochloride alone (BH) using a clinical trial randomization tool from the National Cancer Institute. Randomization was stratified based on the recruitment site and type of surgery (lumpectomies with and without SLNB). The treatment groups were balanced using randomly assigned numbers. The injection of LB-BH or BH were given prior to incision. Then on day 2 of post surgery a nurse called to ask for pain level 0-10 with 0 being no pain at all and 10 being the worst pain they ever had , then same question was asked on post surgery day 9. Then, they were chart checked from electronic medical record to see if they called offices for pain related questions or asking for opioid pain medications or had ED visits. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Bioequivalence |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bupivacaine hydrochloride and bupivacaine hydrochloride |
| Primary outcome measure | Pain measured using NRS on day 2 and day 9 post surgery |
| Secondary outcome measures | Adjunctive opioid use, pain-related ED visits, office calls, requests for pain scripts measured using patient records after day 9 post surgery |
| Overall study start date | 15/02/2023 |
| Completion date | 28/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 76 |
| Key inclusion criteria | Adults over the age of 18 who undergo lumpectomies and able to consent |
| Key exclusion criteria | 1. Patients undergoing any other procedures other than lumpectomies 2. Patients who are getting lumpectomies with any other procedures |
| Date of first enrolment | 21/04/2023 |
| Date of final enrolment | 23/02/2024 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Lansing
48912
United States of America
Sponsor information
Research organisation
1200 E. Michigan ave
Lansing
48912
United States of America
| Phone | +1-517-364-5402 |
|---|---|
| irb@umhsparrow.org | |
| Website | https://www.uofmhealthsparrow.org/ |
Funders
Funder type
Not defined
Private sector organisation / Other non-profit organizations
- Location
- United States of America
Results and Publications
| Intention to publish date | 15/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request irada.mamukadze@umhsparrow.org |
Editorial Notes
14/10/2024: Trial's existence confirmed by Sparrow Health System IRB
