Postoperative PainNCT03415646
The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
A study testing Erector Spinae Plane Block in people with Postoperative Pain and Breast Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of… Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Postoperative Pain, Breast Cancer
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2018to 7 Mar 2018
- 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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25-70 years of age
- ASA I-II
- Undergoing elective breast cancer surgery
Who cannot join
- obesity (body mass index >35 kg/m2)
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- recent use of analgesic drugs.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Hospital
İzmit, Kocaeli, 41340
About this study
Postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast surgery.
- Conditions
- Postoperative Pain, Breast Cancer
- Being tested
- Erector Spinae Plane Block, Intravenous Morphine patient controlled analgesia device
- Keywords
- erector spinae plane block, breast surgery, postoperative pain
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
erector spinae plane block with double level injection will be administered before the surgery
Intravenous Morphine patient controlled analgesia deviceDevice
24 hour morphine consumption will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Block Group | Active comparator | Erector Spinae Plane Block administered group Receives: Other: Erector Spinae Plane Block; Device: Intravenous Morphine patient controlled analgesia device |
| Control Group | Sham comparator | Control group Receives: Device: Intravenous Morphine patient controlled analgesia device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Measured: 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start3 Feb 2018
- Primary completion5 Mar 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can AKSU, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415646
- Sponsor's protocol ID
- 2017-377
- Status last verified
- Mar 2018
- First submitted
- 10 Jan 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
- ClinicalTrials.gov ID
- NCT03415646
- Acronym / sponsor ID
- 2017-377
- Conditions
- Postoperative Pain, Breast Cancer
- Keywords
- erector spinae plane block, breast surgery, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 3 Feb 2018 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 30 Jan 2018 (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 in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block Group | Active comparator | Other: Erector Spinae Plane Block, Device: Intravenous Morphine patient controlled analgesia deviceErector Spinae Plane Block administered group |
| Control Group | Sham comparator | Device: Intravenous Morphine patient controlled analgesia deviceControl group |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25-70 years of age
- ASA I-II
- Undergoing elective breast cancer surgery
Key exclusion criteria (5 listed)
- obesity (body mass index >35 kg/m2)
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- recent use of analgesic drugs.
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 |
|---|---|---|
| Erector Spinae Plane Blockerector spinae plane block with double level injection will be administered before the surgery | Other | Block Group |
| Intravenous Morphine patient controlled analgesia device24 hour morphine consumption will be recorded | Device | Block Group, Control Group |
Primary outcome
Morphine consumption
Time frame: 24 hour 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 9 Mar 2018.
- Individual participant dataSharing planned: No
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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 Erector Spinae Plane Block in people with Postoperative Pain and Breast Cancer, run by Kocaeli University 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 3 inclusion and 5 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 9 Mar 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 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. 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?
Morphine consumption (time frame: 24 hour 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 9 Mar 2018.