Postoperative PainNCT04512391
Analgesic Efficacy of Erector Spinae Plane Block After Breast Cancer Surgery
An observational study of Postoperative Pain and Breast Cancer, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Erector spinae plane block(ESPB), which is firstly used for thoracic neuropathic pain, is newly developed and highly promising fascial plane block for providing postoperative analgesia for a great deal of surgeries including breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain, Breast Cancer
- What is being tested?
- Ultrasound guided Erector Spinae Plane Block (ESPB)
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 3 Mar 2021
- Phase
- Observational
- 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 65 years
- Women only
- Adult, Older adult
Study population: all patients undergoing breast surgery for breast cancer between September 2018 and December 2019 were included in our study.
Who may be able to join
- ASA I-II patients undergoing breast surgery for breast cancer
- Becoming available of complete records about study data
Who cannot join
- ASA III-IV patients
- missing records about study data
Trial locations and contacts
1 site in 1 country.
About this study
Erector spinae plane block(ESPB), which is firstly used for thoracic neuropathic pain, is newly developed and highly promising fascial plane block for providing postoperative analgesia for a great deal of surgeries including breast surgery. The investigators aim to study efficacy of ESPB for patients who undergone breast cancer surgery and is expected to benefit from opioid-sparing effect of this technique.
Read the detailed description
This is a retrospective, single-center clinical trial to evaluate analgesic efficacy of Erector spinae plane block (ESPB) after breast cancer surgery. Participant's demographics and medical history, type and extent of surgery, systemic opioid and non-opioid analgesic consumptions, hemodynamic variables and adverse events during and first 24 hours after surgery. After operation, pain scores at first 24 hours, 1., 3., and 6. month will be obtanied from surgical ward and pain clinic registires. patient controlled analgesia device usage history will be obtained from device database at our clinic.
- Conditions
- Postoperative Pain, Breast Cancer
- Being tested
- Ultrasound guided Erector Spinae Plane Block (ESPB)
- Keywords
- Erector spinae plane block, breast cancer, surgery, postoperative pain, analgesic
- 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.
Ultrasound guided Erector Spinae Plane Block (ESPB)Procedure or surgery
Ultrasound guided ESPB is applied at T4 vertebrae level, 3 cm lateral to mid-line where transverse process lies. After identification of transverse process, needle is advanced in plane and real time visualisation on ultrasound screen. When bonny contact is encountered, normal saline is injected for verification of placement, then, 25 ml %0,25 bupivacaine is injected plane between transverse process and erector spinae muscles.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae | patients who are administered ultrasound guided ESPB at T4 vertebrae level with long acting local anesthetic (%0,25 bupivacaine) and followed up with patient controlled analgesia device and all records about aforementioned data is completely available. Receives: Procedure: Ultrasound guided Erector Spinae Plane Block (ESPB) | |
| Control | patients who are not administered any regional analgesic technique and followed up with patient controlled analgesia device and all records about aforementioned data is completely available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
all patients were given 0.05 mg/kg morphine iv and 1 gr paracetamol 30 minutes before end of surgery and in the recovery room, a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 10 min lockout time. Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Measured: First 24 hours after surgery
Verbal Analog Pain Scores on rest and movement
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
Measured: First 24 hours after surgery, at 1., 3., 6. month
Secondary outcomes (5)
Demographic Data
Age, sex, medical history, BMI, ASA (American Society of Anesthesiologists) status, Duration and type of surgery were recorded
Measured: First 24 hours after surgery
Blood Pressures
systolic, diastolic and mean arterial blood pressures as mmHg
Measured: during and first 24 hours after surgery
Heart Rate
Heart rate as beat per minute (BPM)
Measured: during and first 24 hours after surgery
incidence of adverse effects (like nausea and vomiting)
incidence of nausea and vomiting during the 24 hours postoperative period was recorded recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours)
Measured: First 24 hours after surgery
Rescue analgesic requirement
number of request and dosages of non opioid analgesics used for VAS equal or greater than 5 or patient request.
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Sep 2018
- Primary completion31 Dec 2019
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ersin sönmez, TC Erciyes University
- Investigators
- ersin SÖNMEZ, Principal investigator, Research Asisstant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512391
- Sponsor's protocol ID
- 2020/134
- Status last verified
- Mar 2021
- First submitted
- 11 Aug 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
PubMed 29980005
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Erector Spinae Plane Block After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04512391
- Acronym / sponsor ID
- 2020/134
- Conditions
- Postoperative Pain, Breast Cancer
- Keywords
- Erector spinae plane block, breast cancer, surgery, postoperative pain, analgesic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 13 Aug 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.
Erector spinae plane block(ESPB), which is firstly used for thoracic neuropathic pain, is newly developed and highly promising fascial plane block for providing postoperative analgesia for a great deal of surgeries including breast surgery. The investigators aim to study efficacy of ESPB for patients who undergone breast cancer surgery and is expected to benefit from opioid-sparing effect of this technique.
Detailed description
This is a retrospective, single-center clinical trial to evaluate analgesic efficacy of Erector spinae plane block (ESPB) after breast cancer surgery. Participant's demographics and medical history, type and extent of surgery, systemic opioid and non-opioid analgesic consumptions, hemodynamic variables and adverse events during and first 24 hours after surgery. After operation, pain scores at first 24 hours, 1., 3., and 6. month will be obtanied from surgical ward and pain clinic registires. patient controlled analgesia device usage history will be obtained from device database at our clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae | – | Procedure: Ultrasound guided Erector Spinae Plane Block (ESPB)patients who are administered ultrasound guided ESPB at T4 vertebrae level with long acting local anesthetic (%0,25 bupivacaine) and followed up with patient controlled analgesia device and all records about aforementioned data is completely available. |
| Control | – | –patients who are not administered any regional analgesic technique and followed up with patient controlled analgesia device and all records about aforementioned data is completely available. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- all patients undergoing breast surgery for breast cancer between September 2018 and December 2019 were included in our study.
Key inclusion criteria (2 listed)
- ASA I-II patients undergoing breast surgery for breast cancer
- Becoming available of complete records about study data
Key exclusion criteria (2 listed)
- ASA III-IV patients
- missing records about study data
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 Erector Spinae Plane Block (ESPB)Ultrasound guided ESPB is applied at T4 vertebrae level, 3 cm lateral to mid-line where transverse process lies. After identification of transverse process, needle is advanced in plane and real time visualisation on ultrasound screen. When bonny contact is encountered, normal saline is injected for verification of placement, then, 25 ml %0,25 bupivacaine is injected plane between transverse process and erector spinae muscles. | Procedure or surgery | Erector Spinae |
Primary outcome
Opioid Consumption
Time frame: First 24 hours after surgery
all patients were given 0.05 mg/kg morphine iv and 1 gr paracetamol 30 minutes before end of surgery and in the recovery room, a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 10 min lockout time. Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Verbal Analog Pain Scores on rest and movement
Time frame: First 24 hours after surgery, at 1., 3., 6. month
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
5 secondary outcomes
Demographic Data
Time frame: First 24 hours after surgery
Blood Pressures
Time frame: during and first 24 hours after surgery
Heart Rate
Time frame: during and first 24 hours after surgery
incidence of adverse effects (like nausea and vomiting)
Time frame: First 24 hours after surgery
Rescue analgesic requirement
Time frame: First 24 hours after surgery
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 11 Mar 2021.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 29980005Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
- 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.
ersin SÖNMEZ principal investigator
Research Asisstant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Breast Cancer, run by TC Erciyes 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 2 inclusion and 2 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 11 Mar 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.
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?
Opioid Consumption (time frame: First 24 hours after surgery). The study lists 2 primary outcomes in all. 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 NCT04512391, which also lists 2 linked publications.
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 11 Mar 2021.