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Status unknownNCT06129383Updated Nov 22, 2023

The Effect of Adding PIFP Block to SAP Block on Postoparative Pain Management in Patient Planned for Breast Surgery

An interventional study of serratus anterior plane block and pectointercostal plane block in breast surgery in Pain Management, sponsored by Uludag University. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Uludag University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Pain Management

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Keywords

  • Pecto-intercostal facial block
  • breast surgery
03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Uludag University is the lead sponsor of 145 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    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.

    Procedure: serratus anterior plane block and pectointercostal plane block in breast surgery

  • Other
    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.

    Procedure: serratus anterior plane block and pectointercostal plane block in breast surgery

Interventions

  • Procedureserratus 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within posoparativ 24 hours

07

Study locations

1 of 1 sites recruiting
  • ULUDAGU
    Bursa, 16110, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Feb 2024, 5 months after the start.

Of 606 non-industry interventional studies with no phase under Agnosia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 5 months is below that.

Counting every sponsor, half of 615 studies reached it within 12 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2023
First posted
Nov 13, 2023
StartActual
Sep 7, 2023
Primary completionEst.
Feb 7, 2024
CompletionEst.
May 7, 2024
Last update
Nov 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06129383
Lead sponsor
Uludag University
Responsible party
Özlem Gök (DOCTOR, Uludag University) — Principal investigator
First posted
Nov 13, 2023
Start date
Sep 7, 2023
Primary completion
Feb 7, 2024 (estimated)
Completion
May 7, 2024 (estimated)
Last update
Nov 22, 2023

Study contacts

Özlem Gök
Contact
ozlmgktp@gmail.com
+905469379652
Belgin Yavaşçaoglu, prof
study director · Uludag University Medicine Faculty
SELCAN AKESEN, assoc.prof
study chair · Uludag University Medicine Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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