Breast CancerNCT02483923
Analgesic Effect to Postoperative Pain After Mastectomy: Ultrasound-guided Serratus Anterior Plane Block
A study testing Ultrasound guided serratus anterior block with ropivacaine and intravenous PCA only in people with Breast Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and consumption of opioid after mastectomy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound guided serratus anterior block with ropivacaine and intravenous PCA only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jun 2015to 28 Feb 2016
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1~3
- Age 20~80
- Breast cancer patient twho are scheduled for elective mastectomy
Who cannot join
- Allergy to local anesthetics or contraindication to use of ropivacaine
- Pregnancy
- Severe cardiovascular disease
- Renal failure
- Liver failure
- Neurologic and psychologic disease
- Chronic treatment with analgesics
- Previous history of mastectomy or thoracic surgery.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and consumption of opioid after mastectomy.
- Conditions
- Breast Cancer
- Being tested
- Ultrasound guided serratus anterior block with ropivacaine, intravenous PCA only
- Keywords
- serratus anterior block, ultrasound, breast cancer, postoperative pain
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided serratus anterior block with ropivacaineDrug
After induction of anesthesia, patients take ultrasound guided serratus anterior plane block with 0.5ml/kg of ropivacaine 0.375%. 30minutes before the end of operation, intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient.
intravenous PCA onlyDrug
same dose of intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient only.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | Not described Receives: Drug: Ultrasound guided serratus anterior block with ropivacaine |
| Group C | Placebo comparator | Not described Receives: Drug: intravenous PCA only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Assessing total opioid consumption (total number of bolus injection and total dose of fentanyl via intravenous patient controlled analgesia) within 24hours after operation finished.
Measured: within 24 hrs after mastectomy
Secondary outcomes (5)
Postoperative pain scale (Numeric rating scale 0-10) at PACU
Measured: chang from 3,6,12,24 to 48hrs after operation end
Total intraoperative remifentanil consumption(mcg)
Measured: within 24 hrs after mastectomy
Additional analgesics requirements (dose/number)
Measured: within 24 hrs after mastectomy
incidence and intensity of postoperative nausea and vomiting(NRS:0-10)
Measured: within 24 hrs after mastectomy
Total hospital staying time
Measured: within 24 hrs after mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start16 Jun 2015
- Primary completion28 Feb 2016
- Study completion28 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483923
- Sponsor's protocol ID
- 4-2015-0363
- Status last verified
- Jul 2018
- First submitted
- 18 Jun 2015
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect to Postoperative Pain After Mastectomy: Ultrasound-guided Serratus Anterior Plane Block
- ClinicalTrials.gov ID
- NCT02483923
- Acronym / sponsor ID
- 4-2015-0363
- Conditions
- Breast Cancer
- Keywords
- serratus anterior block, ultrasound, breast cancer, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 28 Feb 2016 (actual)
- First posted
- 29 Jun 2015 (estimated)
- 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.
Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and consumption of opioid after mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Drug: Ultrasound guided serratus anterior block with ropivacaine |
| Group C | Placebo comparator | Drug: intravenous PCA only |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1~3
- Age 20~80
- Breast cancer patient twho are scheduled for elective mastectomy
Key exclusion criteria (8 listed)
- Allergy to local anesthetics or contraindication to use of ropivacaine
- Pregnancy
- Severe cardiovascular disease
- Renal failure
- Liver failure
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 |
|---|---|---|
| Ultrasound guided serratus anterior block with ropivacaineAfter induction of anesthesia, patients take ultrasound guided serratus anterior plane block with 0.5ml/kg of ropivacaine 0.375%. 30minutes before the end of operation, intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient. | Drug | Group S |
| intravenous PCA onlysame dose of intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient only. | Drug | Group C |
Primary outcome
Total opioid consumption
Time frame: within 24 hrs after mastectomy
Assessing total opioid consumption (total number of bolus injection and total dose of fentanyl via intravenous patient controlled analgesia) within 24hours after operation finished.
5 secondary outcomes
Postoperative pain scale (Numeric rating scale 0-10) at PACU
Time frame: chang from 3,6,12,24 to 48hrs after operation end
Total intraoperative remifentanil consumption(mcg)
Time frame: within 24 hrs after mastectomy
Additional analgesics requirements (dose/number)
Time frame: within 24 hrs after mastectomy
incidence and intensity of postoperative nausea and vomiting(NRS:0-10)
Time frame: within 24 hrs after mastectomy
Total hospital staying time
Time frame: within 24 hrs after mastectomy
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 17 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided serratus anterior block with ropivacaine and intravenous PCA only in people with Breast Cancer, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 8 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 17 Jul 2018. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Total opioid consumption (time frame: within 24 hrs after mastectomy). 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 17 Jul 2018.