The Effect of Adding PIFP Block to SAP Block on Postoparative Pain Management in Patient Planned for Breast Surgery
NCT ID: NCT06129383
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2023-09-07
2024-05-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group to which serratus anterior plane block will be applied
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.
serratus anterior plane block and pectointercostal plane block in breast 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.
serratus anterior plane block to the pecto intercostal plane block will be applied.
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.
serratus anterior plane block and pectointercostal plane block in breast 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
serratus anterior plane block and pectointercostal plane block in breast 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* not pregnant or suspected of being pregnant
* approve the informed consent form will be included in the study.
Exclusion Criteria
* Infection on injection area
* Serious neurological disorder
* Psychiatric disorder
* Severe cardiovascular disease
* Liver failure
* Renal failure
* Using chronic opioid
18 Years
75 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Uludag University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Özlem Gök
DOCTOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Belgin Yavaşçaoglu, prof
Role: STUDY_DIRECTOR
Uludag University Medicine Faculty
SELCAN AKESEN, assoc.prof
Role: STUDY_CHAIR
Uludag University Medicine Faculty
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ULUDAGU
Bursa, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-16/7
Identifier Type: -
Identifier Source: org_study_id