Pain ManagementNCT06129383
The Effect of Adding PIFP Block to SAP Block on Postoparative Pain Management in Patient Planned for Breast Surgery
A study testing serratus anterior plane block and pectointercostal plane block in breast surgery in people with Pain Management, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
the study is a clinical study that will be conducted on women between the ages of 18 and 75 who are scheduled for breast surgery. We aimed to compare the postoperative pain management effect of adding the pecto intercostal fascial plane block to the serratus anterior plane block. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- serratus anterior plane block and pectointercostal plane block in breast surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Sep 2023to 7 May 2024
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I-III groups,
- not pregnant or suspected of being pregnant
- approve the informed consent form will be included in the study.
Who cannot join
- Patients with known local anesthetic allergy or suspected coagulopathy,
- Infection on injection area
- Serious neurological disorder
- Psychiatric disorder
- Severe cardiovascular disease
- Liver failure
- Renal failure
- Using chronic opioid
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
ULUDAGU
Bursa, 16110
Özlem, Gök, +905469379652, ozlmgktp@gmail.com
About this study
Official title: The Effect of Adding Pectointercostal Plane Block to Serratus Anterior Plane Block on Postoparative Pain Management in Patient Planned for Breast Surgery
the study is a clinical study that will be conducted on women between the ages of 18 and 75 who are scheduled for breast surgery. We aimed to compare the postoperative pain management effect of adding the pecto intercostal fascial plane block to the serratus anterior plane block.
Read the detailed description
Patients between the ages of 18-75 who are scheduled for breast surgery, who are in American Society of Anesthesiologists (ASA) class I-III groups, who are not pregnant or suspected of being pregnant, and who approve the informed consent form will be included in the study. Patients with known local anesthetic allergy or suspected coagulopathy, injection site infection, serious neurological or psychiatric disorder, severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2) and chronic opioid use are excluded from the study will be left.
Within the scope of this study, two different research groups were identified for which clinical research was planned. The significance level of the power analysis was determined as 0.05 and the power level was determined as 0.80. However, for this study, it was decided to consider the effect size value as 0.4, based on similar studies in the literature. It was deemed sufficient to include n = 26 cases in each group, and it was deemed appropriate to include n = 30 cases in each group, considering a 20% wastage margin. The cases will be divided into 2 groups of 30 people using the sealed envelope method. Group I will include patients who underwent SAP block under general anesthesia (Control group), and Group II will include patients who underwent SAP and PIFB block under general anesthesia (Experimental group). Demographic information (weight, height, age, body mass index, comorbidity ASA score) of all cases will be recorded. After informed consent was obtained in all cases; Standard monitoring including HR, SS, SpO2 non-invasive blood pressure, and 5-lead electrocardiography will be performed. Following anesthesia induction with midazolam 0.05 mg\kg intravenous (IV), propofol 2.5 mg\kg IV, fentanyl 2 mcg\kg IV, lidocaine 1 mg\kg IV and rocuronium 1 mg\kg IV, which the investigators routinely use in our clinic for general anesthesia. It is planned to maintain anesthesia with sevoflurane in patients whose airway is provided with a laryngeal mask, with a minimum alveolar concentration (MAC) of 1. The patient is placed in the lateral decubitus position and serratus guided by the 38 mm 6 MHz linear probe of the ultrasound device, which is routinely applied to Group I (Control group) patients in our clinic. SAP block will be applied to the anterior muscle fascia using 20 ml of 0.25% bupivacaine solution. For Group II (Experimental group) patients, SAP block will be applied to the serratus anterior muscle fascia using 20 ml of 0.25% bupivacaine solution, accompanied by the 38 mm 6 MHz linear probe of the ultrasonography device that is routinely applied in our clinic. The patient will be placed in the lateral decubitus position. Then, the patient will be placed in the supine position and 4 strokes will be applied in the parasternal region. PIFB will be applied using 10 ml of 0.25% bupivacaine solution between the pectoralis major and external intercostal muscle fasciae at the level of the intercostal space. In the intraoperative period, paracetamol 1000 mg IV and tenoxicam 20 mg IV will be administered to all patients as the investigators routinely apply. The patients' hemodynamic data and the amount of opioid used during the operation will be recorded every 30 minutes during the intraoperative period.
In the postoperative period, patients' visual pain score (VAS) and VAS score during movement will be measured at the 1st, 2nd, 4th, 8th, 12th and 24th hours. In addition, the patients' first additional analgesic time, additional analgesic requirement and consumption amount will be recorded.
It is planned to give paracetamol 4x500 mg IV as a rescue analgesic in patients with a VAS score of 4 and above in the postoperative period, and tramadol 1 mg\kg IV as a second rescue analgesic in patients whose VAS score continues to be 4 and above during their follow-up.
- Conditions
- Pain Management
- Being tested
- serratus anterior plane block and pectointercostal plane block in breast surgery
- Keywords
- Pecto-intercostal facial block, breast surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus anterior plane block and pectointercostal plane block in breast surgeryProcedure or surgery
Serratus anterior plane block and pecto intercostal plane block will be performed as a single injection using 0.25% bupivacaine and with the same practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Control group to which serratus anterior plane block will be applied | Active comparator | Control group patients, accompanied by the 38 mm 6 MHz linear probe of the ultrasound device, , the patient will be placed in the lateral decubitus position and SAP block will be applied to the serratus anterior muscle fascia using 20 ml of 0.25% bupivacaine solution. Receives: Procedure: serratus anterior plane block and pectointercostal plane block in breast surgery |
| serratus anterior plane block to the pecto intercostal plane block will be applied. | Other | SAP block will be applied to the patient's serratus anterior fascia using 20 ml of 0.25% bupivacaine solution. Then, PIFB will be applied to the patient's parasternal region using 10 ml of 0.25% bupivacaine solution. Receives: Procedure: serratus anterior plane block and pectointercostal plane block in breast surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on analgesic needs of patients in the first 24 hours postoperatively
Patients' visula pain score should be below 4 within 24 hours post-operatively and the need for analgesia should be reduced or absent.
Measured: within posoparativ 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start7 Sep 2023
- Primary completion7 Feb 2024 (estimated)
- Study completion7 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within the scope of this study, two different research groups were identified for which clinical research was planned. The significance level of the power analysis was determined as 0.05 and the power level was determined as 0.80. However, for this study, it was decided to consider the effect size value as 0.4, based on similar studies in the literature. It was deemed sufficient to include n = 26 cases in each group, and it was deemed appropriate to include n = 30 cases in each group, considering a 20% wastage margin. The cases will be divided into 2 groups of 30 people using the sealed envelope method. Group I will include patients who underwent SAP block under general anesthesia (Control group), and Group II will include patients who underwent SAP and PIFB block under general anesthesia (Experimental group).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Gök, Uludag University
- Investigators
- Belgin Yavaşçaoglu, prof, Study director, Uludag University Medicine FacultySELCAN AKESEN, assoc.prof, Study chair, Uludag University Medicine Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129383
- Sponsor's protocol ID
- 2023-16/7
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 22 Nov 2023
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Pectointercostal Plane Block to Serratus Anterior Plane Block on Postoparative Pain Management in Patient Planned for Breast Surgery
- ClinicalTrials.gov ID
- NCT06129383
- Acronym / sponsor ID
- 2023-16/7
- Conditions
- Pain Management
- Keywords
- Pecto-intercostal facial block, breast surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 7 Feb 2024 (estimated)
- Study completion
- 7 May 2024 (estimated)
- First posted
- 13 Nov 2023 (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.
the study is a clinical study that will be conducted on women between the ages of 18 and 75 who are scheduled for breast surgery. We aimed to compare the postoperative pain management effect of adding the pecto intercostal fascial plane block to the serratus anterior plane block.
Detailed description
Patients between the ages of 18-75 who are scheduled for breast surgery, who are in American Society of Anesthesiologists (ASA) class I-III groups, who are not pregnant or suspected of being pregnant, and who approve the informed consent form will be included in the study. Patients with known local anesthetic allergy or suspected coagulopathy, injection site infection, serious neurological or psychiatric disorder, severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2) and chronic opioid use are excluded from the study will be left.
Within the scope of this study, two different research groups were identified for which clinical research was planned. The significance level of the power analysis was determined as 0.05 and the power level was determined as 0.80. However, for this study, it was decided to consider the effect size value as 0.4, based on similar studies in the literature. It was deemed sufficient to include n = 26 cases in each group, and it was deemed appropriate to include n = 30 cases in each group, considering a 20% wastage margin. The cases will be divided into 2 groups of 30 people using the sealed envelope method. Group I will include patients who underwent SAP block under general anesthesia (Control group), and Group II will include patients who underwent SAP and PIFB block under general anesthesia (Experimental group). Demographic information (weight, height, age, body mass index, comorbidity ASA score) of all cases will be recorded. After informed consent was obtained in all cases; Standard monitoring including HR, SS, SpO2 non-invasive blood pressure, and 5-lead electrocardiography will be performed. Following anesthesia induction with midazolam 0.05 mg\kg intravenous (IV), propofol 2.5 mg\kg IV, fentanyl 2 mcg\kg IV, lidocaine 1 mg\kg IV and rocuronium 1 mg\kg IV, which the investigators routinely use in our clinic for general anesthesia. It is planned to maintain anesthesia with sevoflurane in patients whose airway is provided with a laryngeal mask, with a minimum alveolar concentration (MAC) of 1. The patient is placed in the lateral decubitus position and serratus guided by the 38 mm 6 MHz linear probe of the ultrasound device, which is routinely applied to Group I (Control group) patients in our clinic. SAP block will be applied to the anterior muscle fascia using 20 ml of 0.25% bupivacaine solution. For Group II (Experimental group) patients, SAP block will be applied to the serratus anterior muscle fascia using 20 ml of 0.25% bupivacaine solution, accompanied by the 38 mm 6 MHz linear probe of the ultrasonography device that is routinely applied in our clinic. The patient will be placed in the lateral decubitus position. Then, the patient will be placed in the supine position and 4 strokes will be applied in the parasternal region. PIFB will be applied using 10 ml of 0.25% bupivacaine solution between the pectoralis major and external intercostal muscle fasciae at the level of the intercostal space. In the intraoperative period, paracetamol 1000 mg IV and tenoxicam 20 mg IV will be administered to all patients as the investigators routinely apply. The patients' hemodynamic data and the amount of opioid used during the operation will be recorded every 30 minutes during the intraoperative period.
In the postoperative period, patients' visual pain score (VAS) and VAS score during movement will be measured at the 1st, 2nd, 4th, 8th, 12th and 24th hours. In addition, the patients' first additional analgesic time, additional analgesic requirement and consumption amount will be recorded.
It is planned to give paracetamol 4x500 mg IV as a rescue analgesic in patients with a VAS score of 4 and above in the postoperative period, and tramadol 1 mg\kg IV as a second rescue analgesic in patients whose VAS score continues to be 4 and above during their follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Within the scope of this study, two different research groups were identified for which clinical research was planned. The significance level of the power analysis was determined as 0.05 and the power level was determined as 0.80. However, for this study, it was decided to consider the effect size value as 0.4, based on similar studies in the literature. It was deemed sufficient to include n = 26 cases in each group, and it was deemed appropriate to include n = 30 cases in each group, considering a 20% wastage margin. The cases will be divided into 2 groups of 30 people using the sealed envelope method. Group I will include patients who underwent SAP block under general anesthesia (Control group), and Group II will include patients who underwent SAP and PIFB block under general anesthesia (Experimental group).
| Arm | Type | Receives |
|---|---|---|
| Control group to which serratus anterior plane block will be applied | Active comparator | Procedure: serratus anterior plane block and pectointercostal plane block in breast surgeryControl group patients, accompanied by the 38 mm 6 MHz linear probe of the ultrasound device, , the patient will be placed in the lateral decubitus position and SAP block will be applied to the serratus anterior muscle fascia using 20 ml of 0.25% bupivacaine solution. |
| serratus anterior plane block to the pecto intercostal plane block will be applied. | Other | Procedure: serratus anterior plane block and pectointercostal plane block in breast surgerySAP block will be applied to the patient's serratus anterior fascia using 20 ml of 0.25% bupivacaine solution. Then, PIFB will be applied to the patient's parasternal region using 10 ml of 0.25% bupivacaine solution. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) class I-III groups,
- not pregnant or suspected of being pregnant
- approve the informed consent form will be included in the study.
Key exclusion criteria (8 listed)
- Patients with known local anesthetic allergy or suspected coagulopathy,
- Infection on injection area
- Serious neurological disorder
- Psychiatric disorder
- Severe cardiovascular disease
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 |
|---|---|---|
| serratus anterior plane block and pectointercostal plane block in breast surgerySerratus anterior plane block and pecto intercostal plane block will be performed as a single injection using 0.25% bupivacaine and with the same practitioner. | Procedure or surgery | Control group to which serratus anterior plane block will be applied, serratus anterior plane block to the pecto intercostal plane block will be applied. |
Primary outcome
Change on analgesic needs of patients in the first 24 hours postoperatively
Time frame: within posoparativ 24 hours
Patients' visula pain score should be below 4 within 24 hours post-operatively and the need for analgesia should be reduced or absent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- 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.
Belgin Yavaşçaoglu, prof study director
Uludag University Medicine Faculty
SELCAN AKESEN, assoc.prof study chair
Uludag University Medicine Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serratus anterior plane block and pectointercostal plane block in breast surgery in people with Pain Management, run by Uludag 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 8 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özlem Gök (+905469379652, ozlmgktp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on analgesic needs of patients in the first 24 hours postoperatively (time frame: within posoparativ 24 hours). 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 22 Nov 2023.