Postoperative PainNCT04689581
Comparison of Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Surgery
A study testing Ultrasound guided bi-level erector spinae plane block and Ultrasound guided modified pectoral nerve block in people with Postoperative Pain and Analgesia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi level erector spinae plane (ESP) block on postoperative analgesic effect in breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Pain, Analgesia
- What is being tested?
- Ultrasound guided bi-level erector spinae plane block and Ultrasound guided modified pectoral nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 15 Jan 2021
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists Classification (ASA) I-II patients
- 18-70 aged patients
- patients who scheuled elective breast cancer surgery
Who cannot join
- American Society of Anesthesiologists Classification (ASA) III-IV patients
- patients with coagulopathy
- patients with infection at the injection site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Efficacy of Ultrasound-guided Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Cancer Surgery
In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi level erector spinae plane (ESP) block on postoperative analgesic effect in breast surgery.
Read the detailed description
After being informed about the study and potential risks, written consent was obtained from all patients. Patients who meet eligibility requirements will be randomized in a 1:1 ratio to bi- level erector spinae plane block and modified pectoral block.
- Conditions
- Postoperative Pain, Analgesia
- Being tested
- Ultrasound guided bi-level erector spinae plane block, Ultrasound guided modified pectoral nerve block
- Keywords
- Regional anaesthesia, Erector spinae plane block, PECs blocks, Breast cancer surgery
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided bi-level erector spinae plane blockOther
Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group.
Ultrasound guided modified pectoral nerve blockOther
Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.
| Study group | Role | What they receive |
|---|---|---|
| Bi-level erector spinae plane block | Experimental | Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group. Receives: Other: Ultrasound guided bi-level erector spinae plane block |
| Modified pectoral nerve block | Experimental | Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group. Receives: Other: Ultrasound guided modified pectoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphin consumption
Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.
Measured: during postoperative 24 hour
numerical rating scale (NRS)
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Measured: during postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jan 2020
- Primary completion10 Jan 2021
- Study completion15 Jan 2021
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Cesur, Kocaeli University
- Investigators
- Sevim Cesur, MD, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689581
- Sponsor's protocol ID
- KOU KAEK 2018/487
- Status last verified
- Jun 2021
- First submitted
- 27 Dec 2020
- Last updated
- 29 Jun 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 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Efficacy of Ultrasound-guided Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04689581
- Acronym / sponsor ID
- KOU KAEK 2018/487
- Conditions
- Postoperative Pain, Analgesia
- Keywords
- Regional anaesthesia, Erector spinae plane block, PECs blocks, Breast cancer surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 30 Dec 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.
In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi level erector spinae plane (ESP) block on postoperative analgesic effect in breast surgery.
Detailed description
After being informed about the study and potential risks, written consent was obtained from all patients. Patients who meet eligibility requirements will be randomized in a 1:1 ratio to bi- level erector spinae plane block and modified pectoral block.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bi-level erector spinae plane block | Experimental | Other: Ultrasound guided bi-level erector spinae plane blockBi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group. |
| Modified pectoral nerve block | Experimental | Other: Ultrasound guided modified pectoral nerve blockUltrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists Classification (ASA) I-II patients
- 18-70 aged patients
- patients who scheuled elective breast cancer surgery
Key exclusion criteria (3 listed)
- American Society of Anesthesiologists Classification (ASA) III-IV patients
- patients with coagulopathy
- patients with infection at the injection site
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 bi-level erector spinae plane blockBi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group. | Other | Bi-level erector spinae plane block |
| Ultrasound guided modified pectoral nerve blockUltrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group. | Other | Modified pectoral nerve block |
Primary outcome
Morphin consumption
Time frame: during postoperative 24 hour
Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.
numerical rating scale (NRS)
Time frame: during postoperative 24 hour
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
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 29 Jun 2021.
- Efficacy of erector spinae plane block for analgesia in breast surgery: a systematic review and meta-analysisLink provided by the sponsor.
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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.
Sevim Cesur, MD principal investigator
Kocaeli University
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 bi-level erector spinae plane block and Ultrasound guided modified pectoral nerve block in people with Postoperative Pain and Analgesia, 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 3 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 29 Jun 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?
Morphin consumption (time frame: during postoperative 24 hour). 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?
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 29 Jun 2021.