Regional anesthesia in breast reconstructive surgery
| ISRCTN | ISRCTN14701722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14701722 |
- Submission date
- 28/11/2024
- Registration date
- 28/01/2025
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study aims to find out if using regional anesthesia during breast reconstruction surgery can lower pain levels, reduce the need for painkillers and opioids, decrease complications after surgery, and shorten hospital stays.
Who can participate?
Women aged 18 to 90 years who are scheduled for radical breast surgery (such as Skin-Sparing Mastectomy or Nipple-Sparing Mastectomy) or standard mastectomy (Modified Radical Mastectomy) with primary reconstruction using a prosthesis or expander placed beneath the pectoral muscle.
What does the study involve?
Participants will be randomly assigned to one of two groups. One group will receive the standard general anesthesia, while the other group will receive regional anesthesia. Both groups will complete a pain questionnaire before surgery and at 6 and 24 hours after surgery. The study will also record the use of painkillers and opioids, any complications within 24 hours after surgery, and the length of hospital stay.
What are the possible benefits and risks of participating?
Participants who receive regional anesthesia may experience lower pain levels after surgery. There are no additional risks compared to the usual procedure.
Where is the study run from?
University Hospital Dubrava/Klinička Bolnica Dubrava (Croatia)
When is the study starting and how long is it expected to run for?
October 2021 to June 2024
Who is funding the study?
University Hospital Dubrava/Klinička Bolnica Dubrava (Croatia)
Who is the main contact?
Domagoj Eljuga, deljuga@gmail.com
Contact information
Principal Investigator
Maksimirska cesta 88
Zagreb
10000
Croatia
 ORCID ID |
0000-0001-8902-0072 |
|---|---|
| Phone | +385 91 383 99 50 |
| deljuga@gmail.com |
Public
Nova cesta 136A
Zagreb
10000
Croatia
| ORCID ID |
0009-0002-6025-4806 |
|---|---|
| Phone | +38598 752178 |
| kmartic76@gmail.com |
Scientific
Ogulinska 4a
Zagreb
10000
Croatia
| ORCID ID |
0000-0002-1755-0039 |
|---|---|
| Phone | +385 98 9050015 |
| ivojurisic1@gmail.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 46485 PIS.pdf |
| Scientific title | Regional anesthesia in breast reconstructive surgery |
| Study objectives | Regional anesthesia in breast reconstructive surgery is associated with lower pain score, lower opioid usage, lower complication rate and shorter hospital stay. |
| Ethics approval(s) |
Approved 22/02/2022, Ethics committee of Clinical Hospital Dubrava (Avenija Gojka Suska 6, Zagreb, 10000, Croatia; +385 1 290 2726; povjerenstvo.eticko@kbd.hr), ref: 2022/2701‐ 04 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Patients will be randomly assigned to one of two groups via blinded selection. 1. First group: Patients will undergo the standard anesthetic protocol used for general anesthesia. 2. Second group: Patients will receive regional anesthesia following this protocol: o Thoracic paravertebral block with 0.3 mL/kg of ideal body weight of 0.5% levobupivacaine + 4 mg dexamethasone + epinephrine (1:200,000), followed by: o Additional pectoral block comprising: 0.2 mL/kg of ideal body weight of 0.5% levobupivacaine + 4 mg dexamethasone + epinephrine (1:200,000) administered between the pectoralis major and pectoralis minor muscles. A supplementary block between the pectoralis minor and serratus anterior muscles with 0.2 mL/kg of ideal body weight of 0.5% levobupivacaine + 2 mg dexamethasone + epinephrine (1:200,000). For premedication, Dormicum (Midazolam) 3–5 mg intramuscularly will be administered 30 minutes before the block (administered in the ward). During block administration, 1–3 mg Dormicum will be given intravenously. During surgery, deep sedation will be achieved with Propofol at a dose of 30–70 mcg/kg per minute, along with oxygen via mask at 12 L/min. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Dose response, Pharmacoeconomic |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | levobupivacaine, dexamethasone, epinephrine, Dormicum (midazolam), propofol |
| Primary outcome measure | Pain is measured using a visual analogue scale at baseline, 6 and 24h |
| Secondary outcome measures | Measured using patient records after hospital stay: 1. Opioid consumption 2. Duration of hospital stay |
| Overall study start date | 01/10/2021 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Female |
| Target number of participants | 70 |
| Total final enrolment | 50 |
| Key inclusion criteria | Women aged 18–90 years scheduled for radical breast surgery (Skin-Sparing Mastectomy (SSM) or Nipple-Sparing Mastectomy (NSM)) or standard mastectomy (Modified Radical Mastectomy (MRM)) with primary reconstruction using a prosthesis or expander placed beneath the pectoral muscle |
| Key exclusion criteria | Patients experiencing chronic pain or those undergoing pain therapy will not be included in the study. |
| Date of first enrolment | 01/02/2022 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Croatia
Study participating centre
Zagreb
10000
Croatia
Sponsor information
Hospital/treatment centre
Avenija Gojka Suska 6
Zagreb
10000
Croatia
| Phone | +385 1 2902 444 |
|---|---|
| info@kbd.hr | |
| Website | http://www.kbd.hr/ |
"ROR" |
https://ror.org/00mgfdc89 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Clinical Hospital Dubrava, KBD
- Location
- Croatia
Results and Publications
| Intention to publish date | 30/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in peer reviewed journal |
| IPD sharing plan | The datasets generated during the current study will be stored in a non-publicly available repository. All data about each individual patient is stored in paper and as well in electronic form in our Regional Anesthesia folder on our Department disk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 29/11/2024 | No | Yes |
Additional files
Editorial Notes
29/11/2024: Trial's existence confirmed by Ethics committee of Clinical Hospital Dubrava.
