Postoperative PainNCT03480958
Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
A study testing Erector Spinae Plane Block and Thoracic Paravertebral 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 etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. 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 and Thoracic Paravertebral Block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2018to 20 Aug 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 agge
- 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.
About this study
Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.
- Conditions
- Postoperative Pain, Breast Cancer
- Being tested
- Intravenous morphine patient controlled device, Erector Spinae Plane Block, Thoracic Paravertebral Block
- Keywords
- erector spinae plane block, thoracic paravertebral 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.
Intravenous morphine patient controlled deviceDevice
24 hour morphine consumption will be recorded
Erector Spinae Plane BlockOther
erector spinae plane block will be administered before the surgery
Thoracic Paravertebral BlockOther
thoracic paravertebral block will be administered before the surgery
| Study group | Role | What they receive |
|---|---|---|
| ESP group | Active comparator | Erector Spinae Plane Block administered group Receives: Device: Intravenous morphine patient controlled device; Other: Erector Spinae Plane Block |
| TPVB group | Active comparator | Thoracic Paravertebral Block administered group Receives: Device: Intravenous morphine patient controlled device; Other: Thoracic Paravertebral Block |
| Control Group | Other | No regional anesthesia technique will be applied to control group; but will be provided with iv PCA Receives: Device: Intravenous morphine patient controlled device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
Measured: 24 hour postoperatively
Secondary outcomes (2)
Numering Rating Scale scores for pain
Numeric Rating Scale (NRS) for pain will be used. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 means no pain and 10 means most imaginable pain
Measured: 24 hour
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting will be recorded
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start28 Mar 2018
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Gurkan, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480958
- Sponsor's protocol ID
- 2018-94
- Status last verified
- Aug 2018
- First submitted
- 18 Mar 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.
PubMed 31280100
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
- ClinicalTrials.gov ID
- NCT03480958
- Acronym / sponsor ID
- 2018-94
- Conditions
- Postoperative Pain, Breast Cancer
- Keywords
- erector spinae plane block, thoracic paravertebral block, breast surgery, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 29 Mar 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 etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESP group | Active comparator | Device: Intravenous morphine patient controlled device, Other: Erector Spinae Plane BlockErector Spinae Plane Block administered group |
| TPVB group | Active comparator | Device: Intravenous morphine patient controlled device, Other: Thoracic Paravertebral BlockThoracic Paravertebral Block administered group |
| Control Group | Other | Device: Intravenous morphine patient controlled deviceNo regional anesthesia technique will be applied to control group; but will be provided with iv PCA |
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 agge
- 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 |
|---|---|---|
| Intravenous morphine patient controlled device24 hour morphine consumption will be recorded | Device | Control Group, ESP group, TPVB group |
| Erector Spinae Plane Blockerector spinae plane block will be administered before the surgery | Other | ESP group |
| Thoracic Paravertebral Blockthoracic paravertebral block will be administered before the surgery | Other | TPVB group |
Primary outcome
Morphine consumption
Time frame: 24 hour postoperatively
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
2 secondary outcomes
Numering Rating Scale scores for pain
Time frame: 24 hour
Postoperative nausea and vomiting
Time frame: 24h
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 28 Aug 2018.
- Derived from this study: PubMed 31280100Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.
- 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 and Thoracic Paravertebral 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 28 Aug 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. 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?
On the ClinicalTrials.gov record for NCT03480958, which also lists 1 linked publication.
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 28 Aug 2018.