AnesthesiaNCT04135157
Pectoral Nerve Block II and Erector Spine Plane Block in Breast Cancer Surgery
A study testing Pectoralis nerve block II and Erector spine plane block in people with Anesthesia and Analgesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the analgesic effects of pectoralis nerve block (PECS II) and erector spinae plane block (ESP) in patients having segmental mastectomy and sentinel lymph node biopsy (SLNB). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia, Analgesia, Acute Pain
- What is being tested?
- Pectoralis nerve block II and Erector spine plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Sep 2020
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy
Who cannot join
- Age <18 or> 65, ASA 3-4 patients
- Obesity (> 100 kg, BMI> 35 kg / m2)
- Patients undergoing bilateral mastectomy
- Pregnancy
- Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
- Serious renal, cardiac, hepatic disease
Show all 12Show fewer
- Hypersensitivity to local anesthetics or a history of allergy
- Patients with a history of opioid use longer than four weeks
- Patients with psychiatric disorders or communication difficulties
- Patients with chest deformity
- Patients with previous breast surgery except diagnostic biopsies
- Patients who do not want to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Faculty of Medicine
Samsun, 55270
About this study
Official title: Research of the Effects of Pectoralis Nerve Block II and Erector Spina Plan Block in Breast Cancer Surgery
This study evaluates the analgesic effects of pectoralis nerve block (PECS II) and erector spinae plane block (ESP) in patients having segmental mastectomy and sentinel lymph node biopsy (SLNB). Each one-third of patients will have ESP block and pectoralis nerve block (PECS II) 30 min before general anesthesia , while other one-third of patients will have only general anesthesia.
Read the detailed description
It has been proven that PECS II and ESP both supply effective analgesia in the first 24 hours after mastectomy. But they do so by different mechanishms.
This study is to survey that ESP and PECS II may supply acute and chronic analgesia by reducing pain scores in the first 24 hours and 3 months after the surgery, also the comparison of the analgesic activity among themselves for acute / chronic pain and opioid consumption will be searched.
In this study patients are divided into three groups. Patients in PECS group will have PECS II block in a separate section from the operating rooms (PNB practice room). In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Patients in ESP group will have ESP block in a separate section from the operating rooms (PNB practice room). In addition, PCA will be used in the first 24 hours postoperatively.
Patients in control group will not be performed nerve block. Only general anesthesia (GA) will be performed in the operation room. In addition, PCA will be used in the first 24 hours postoperatively.
- Conditions
- Anesthesia, Analgesia, Acute Pain, Chronic Pain, Pectoralis Nerve Block, Erector Spine Plane Block
- Being tested
- Pectoralis nerve block II, Erector spine plane block, Control
- Keywords
- Regional Anesthesia, Acute and chronical pain, Pectoralis nerve block, Erector spine plane block
- Medical subject headings
- Agnosia, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoralis nerve block IIProcedure or surgery
Also called PECS II
PECS II block will be performed 30 min. before general anesthesia.
Erector spine plane blockProcedure or surgery
Also called ESP
ESP block will be performed 30 minutes before general anesthesia.
ControlOther
Only general anesthesia will be performed.
| Study group | Role | What they receive |
|---|---|---|
| PECS II or ESP | Experimental | PECS II or ESP block are performed 30 minutes before general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively. Receives: Procedure: Pectoralis nerve block II; Procedure: Erector spine plane block |
| Control | Active comparator | In the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption in the first 24 hours after surgery
Morphine consumption in the first 24 hours will be counted by IV PCA. Patients will be able to request opioids via PCA device when the vas score is 4 points or more when the arm is in the resting position.
Measured: 1 day
Secondary outcomes (5)
Post-operative acute pain
Pain status will be evaluated based on VAS scores in two different positions: arm at rest and arm in abduction. Pain status will be evaluated at 1-3-6-12-24. hours after surgery. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)
Measured: 1 day
Remifentanil consumption during the surgery
Following induction of general anesthesia, anesthesia maintenance will be continued with sevoflurane to BIS 40-60 (bispectral index). When the BIS is between 40-60, remifentanil infusion rate will be changed considering ± 20% changes in blood pressure compared to baseline values.The total amount of remifentanil consumed will be recorded.
Measured: During the surgery
The incidences of post-operative nausea and vomiting (PONV)
The patients will be evaluated according to the five-stage verbal descriptive PONV scale. If it is 3 points or more, ondansetron 4 mg IV will be administered. Wait for 8 hours for the next dose of ondansetron. (0 = None, 1 = Slight nausea, 2 = Moderate nausea, 3 = Once vomiting, 4 = vomiting more than one)
Measured: 1 day
The number of patient required rescue analgesia
The number of patient requires rescue analgesic will be recorded at 1-3-6-12-24. hours after surgery
Measured: 1 day
Post-operative chronic pain
Pain status will be evaluated in the third month after surgery based on VAS scores in two different positions: arm at rest and arm in abduction. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)
Measured: 3. month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Jul 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated generated random numbers.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Collaborators
- CENGİZ KAYA (ckaya)
- Responsible party
- Principal investigator, Caner Genç, Ondokuz Mayıs University
- Investigators
- CENGİZ KAYA, MD, Study director, Ondokuz Mayıs University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135157
- Sponsor's protocol ID
- PA191001001
- Status last verified
- Aug 2021
- First submitted
- 19 Oct 2019
- Last updated
- 18 Aug 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 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of the Effects of Pectoralis Nerve Block II and Erector Spina Plan Block in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04135157
- Acronym / sponsor ID
- PA191001001
- Conditions
- Anesthesia, Analgesia, Acute Pain, Chronic Pain, Pectoralis Nerve Block, Erector Spine Plane Block
- Keywords
- Regional Anesthesia, Acute and chronical pain, Pectoralis nerve block, Erector spine plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Collaborators
- CENGİZ KAYA (ckaya)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 22 Oct 2019 (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.
This study evaluates the analgesic effects of pectoralis nerve block (PECS II) and erector spinae plane block (ESP) in patients having segmental mastectomy and sentinel lymph node biopsy (SLNB). Each one-third of patients will have ESP block and pectoralis nerve block (PECS II) 30 min before general anesthesia , while other one-third of patients will have only general anesthesia.
Detailed description
It has been proven that PECS II and ESP both supply effective analgesia in the first 24 hours after mastectomy. But they do so by different mechanishms.
This study is to survey that ESP and PECS II may supply acute and chronic analgesia by reducing pain scores in the first 24 hours and 3 months after the surgery, also the comparison of the analgesic activity among themselves for acute / chronic pain and opioid consumption will be searched.
In this study patients are divided into three groups. Patients in PECS group will have PECS II block in a separate section from the operating rooms (PNB practice room). In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Patients in ESP group will have ESP block in a separate section from the operating rooms (PNB practice room). In addition, PCA will be used in the first 24 hours postoperatively.
Patients in control group will not be performed nerve block. Only general anesthesia (GA) will be performed in the operation room. In addition, PCA will be used in the first 24 hours postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated generated random numbers.
| Arm | Type | Receives |
|---|---|---|
| PECS II or ESP | Experimental | Procedure: Pectoralis nerve block II, Procedure: Erector spine plane blockPECS II or ESP block are performed 30 minutes before general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively. |
| Control | Active comparator | Other: ControlIn the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy
Key exclusion criteria (12 listed)
- Age <18 or> 65, ASA 3-4 patients
- Obesity (> 100 kg, BMI> 35 kg / m2)
- Patients undergoing bilateral mastectomy
- Pregnancy
- Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, 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 |
|---|---|---|
| Pectoralis nerve block IIAlso: PECS IIPECS II block will be performed 30 min. before general anesthesia. | Procedure or surgery | PECS II or ESP |
| Erector spine plane blockAlso: ESPESP block will be performed 30 minutes before general anesthesia. | Procedure or surgery | PECS II or ESP |
| ControlOnly general anesthesia will be performed. | Other | Control |
Primary outcome
Opioid consumption in the first 24 hours after surgery
Time frame: 1 day
Morphine consumption in the first 24 hours will be counted by IV PCA. Patients will be able to request opioids via PCA device when the vas score is 4 points or more when the arm is in the resting position.
5 secondary outcomes
Post-operative acute pain
Time frame: 1 day
Remifentanil consumption during the surgery
Time frame: During the surgery
The incidences of post-operative nausea and vomiting (PONV)
Time frame: 1 day
The number of patient required rescue analgesia
Time frame: 1 day
Post-operative chronic pain
Time frame: 3. month 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 18 Aug 2021.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
CENGİZ KAYA, MD study director
Ondokuz Mayıs University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pectoralis nerve block II and Erector spine plane block in people with Anesthesia and Analgesia, run by Ondokuz Mayıs 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 1 inclusion and 12 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 18 Aug 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 in the first 24 hours after surgery (time frame: 1 day). 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 18 Aug 2021.