Breast Cancer SurgeryPhase 4NCT04336917
Ultrasound Guided Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Surgeries
A Phase 4 study testing Rhomboid Intercostal and Subserratus Plane Block with local anesthetic in people with Breast Cancer Surgery and Postoperative Analgesia, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative analgesia after breast cancer surgery is a challenge for anesthesiologists due to the complex innervation of the breast. Interfascial plane blocks of the chest are gaining widespread popularity with the introduction of ultrasonography into the regional anesthesia practice. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer Surgery, Postoperative Analgesia
- What is being tested?
- Rhomboid Intercostal and Subserratus Plane Block with local anesthetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2020to 1 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-85 years and ASA physiological score I-III who undergone breast cancer surgery
Who cannot join
- Patients refused to participate.
- Patients with known or suspected allergy to the used medication.
- Patients with psychiatric-neurological disorders that may affect pain perception,
- Patients regularly taking antipsychotics and antidepressants.
- Patients with potential risk of coagulopathy.
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative analgesia after breast cancer surgery is a challenge for anesthesiologists due to the complex innervation of the breast. Interfascial plane blocks of the chest are gaining widespread popularity with the introduction of ultrasonography into the regional anesthesia practice. We aimed to investigate the efficacy of Rhomboid intercostal and subserratus plane block (RISS) for postoperative analgesia in patients undergoing breast cancer surgery.
Read the detailed description
This prospective randomized controlled trial will be carried out on female patients who scheduled for breast cancer surgery. Our hypotesis is that this new interfascial plane block technique will able to provide postoperative analgesia in breast cancer surgery.
- Conditions
- Breast Cancer Surgery, Postoperative Analgesia
- Being tested
- Rhomboid Intercostal and Subserratus Plane Block with local anesthetic
- Keywords
- Rhomboid intercostal and subserratus plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid Intercostal and Subserratus Plane Block with local anestheticDrug
Also called 40 mL of bupivacaine/lidocaine mixture
Local anesthetic will be injected in the tissue planes between the rhomboid and the intercostal muscles and the serratus anterior and external intercostal muscles with ultrasound guidence.
| Study group | Role | What they receive |
|---|---|---|
| Group Rhomboid Intercostal and Subserratus Plane Block | Active comparator | In addition to routine standard perioperative and postoperative analgesic protocol participants will recieve Rhomboid Intercostal and Subserratus Plane Block under ultrasound guidence at the end of the surgery. Receives: Drug: Rhomboid Intercostal and Subserratus Plane Block with local anesthetic |
| Control Group | No intervention | Routine standard perioperative and postoperative analgesic protocol will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opiod consumption
Opioid consumptions for both group will be recorded.
Measured: The first 24 hours postoperatively
Secondary outcomes (1)
Postoperative pain scores
Postoperative pain will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain).The NRS will be recorded in postoperative unit and in ward at first hour and at 2th, 6th, 12th and 24 th hour.
Measured: The first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start31 Aug 2020
- Primary completion5 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
- Investigators
- Betul Kozanhan, M.D., Principal investigator, SBÜ Konya EAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336917
- Sponsor's protocol ID
- Breast Cancer-RISS
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Surgeries
- ClinicalTrials.gov ID
- NCT04336917
- Acronym / sponsor ID
- Breast Cancer-RISS
- Conditions
- Breast Cancer Surgery, Postoperative Analgesia
- Keywords
- Rhomboid intercostal and subserratus plane block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative analgesia after breast cancer surgery is a challenge for anesthesiologists due to the complex innervation of the breast. Interfascial plane blocks of the chest are gaining widespread popularity with the introduction of ultrasonography into the regional anesthesia practice. We aimed to investigate the efficacy of Rhomboid intercostal and subserratus plane block (RISS) for postoperative analgesia in patients undergoing breast cancer surgery.
Detailed description
This prospective randomized controlled trial will be carried out on female patients who scheduled for breast cancer surgery. Our hypotesis is that this new interfascial plane block technique will able to provide postoperative analgesia in breast cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective study
| Arm | Type | Receives |
|---|---|---|
| Group Rhomboid Intercostal and Subserratus Plane Block | Active comparator | Drug: Rhomboid Intercostal and Subserratus Plane Block with local anestheticIn addition to routine standard perioperative and postoperative analgesic protocol participants will recieve Rhomboid Intercostal and Subserratus Plane Block under ultrasound guidence at the end of the surgery. |
| Control Group | No intervention | –Routine standard perioperative and postoperative analgesic protocol will be given. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients aged 18-85 years and ASA physiological score I-III who undergone breast cancer surgery
Key exclusion criteria (6 listed)
- Patients refused to participate.
- Patients with known or suspected allergy to the used medication.
- Patients with psychiatric-neurological disorders that may affect pain perception,
- Patients regularly taking antipsychotics and antidepressants.
- Patients with potential risk of coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhomboid Intercostal and Subserratus Plane Block with local anestheticAlso: 40 mL of bupivacaine/lidocaine mixtureLocal anesthetic will be injected in the tissue planes between the rhomboid and the intercostal muscles and the serratus anterior and external intercostal muscles with ultrasound guidence. | Drug | Group Rhomboid Intercostal and Subserratus Plane Block |
Primary outcome
Postoperative opiod consumption
Time frame: The first 24 hours postoperatively
Opioid consumptions for both group will be recorded.
1 secondary outcome
Postoperative pain scores
Time frame: The first 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
Related trials for Breast Cancer Surgery
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
Recruiting
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
Breast Cancer
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Triple-Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betul Kozanhan, M.D. principal investigator
SBÜ Konya EAH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rhomboid Intercostal and Subserratus Plane Block with local anesthetic in people with Breast Cancer Surgery and Postoperative Analgesia, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opiod consumption (time frame: The first 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.