Breast AugmentationNCT06719726
PECS I Block vs. Local Infiltration in Breast Augmentation Pain Management
A study testing PECS I Block and Local Anesthetic Infiltration in people with Breast Augmentation and Pain Management in Postoperative Care, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the effectiveness of preoperative PECS I block and intraoperative local anesthetic infiltration in managing postoperative pain following breast augmentation surgery. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation, Pain Management in Postoperative Care, Pain Management After Surgery
- What is being tested?
- PECS I Block and Local Anesthetic Infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2024to 3 Feb 2025
- 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 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged 18 to 59 years.
- ASA (American Society of Anesthesiologists) physical status I or II.
- Scheduled for primary breast augmentation surgery using a dual-plane or submuscular approach.
- Planned to receive silicone implants of identical volume and shape for both breasts.
- Able to provide written informed consent.
- Willing and able to comply with study procedures and follow-up assessments.
Who cannot join
- Planned subglandular or subfascial breast augmentation.
- Undergoing revision breast surgery.
- History of breast disease, previous breast or axillary surgery, or breast cancer.
- Preoperative breast pain or chronic pain syndromes (e.g., fibromyalgia, chronic headaches, back pain, complex regional pain syndrome, neuropathic pain, osteoarthritis, or radicular pain).
- BIRADS score > 3 based on imaging (ultrasound/mammography) within the past year.
- Allergy to medications used in the study (e.g., bupivacaine, propofol, fentanyl, sevoflurane, cefazolin, paracetamol, ondansetron, tramadol, or morphine HCl).
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- Coagulopathy or bleeding disorders.
- Pregnant or at risk of pregnancy.
- Inability to provide informed consent or communication difficulties.
- Significant medical conditions that may interfere with the study outcomes.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeditepe University Kozyatagi Hospital
Istanbul, Atasehir, 34752
About this study
Official title: Evaluating Preoperative PECS I Block and Intraoperative Local Anesthetic Infiltration for Postoperative Pain in Breast Augmentation: A Prospective, Double-Blind, Split-Body Study
This study aimed to compare the effectiveness of preoperative PECS I block and intraoperative local anesthetic infiltration in managing postoperative pain following breast augmentation surgery. The primary focus was to evaluate their impact on postoperative pain levels, perioperative remifentanil and postoperative opioid consumption and opioid-related side effects during the early recovery period.
Read the detailed description
Breast augmentation is one of the most performed procedures in aesthetic surgery worldwide.These techniques, which involve muscle dissection and manipulation, tend to be more painful compared to subglandular and subfascial placements. Thus, managing postoperative pain effectively becomes a critical aspect of patient recovery and satisfaction.
To address postoperative pain in breast augmentation, various techniques, including regional anesthesia such as pectoral nerve blocks, local anesthetic infiltration, and pocket irrigation, are employed.
This study aimed to compare the effectiveness of preoperative PECS I block and intraoperative local anesthetic infiltration in managing postoperative pain following breast augmentation surgery. The primary focus was to evaluate their impact on postoperative pain levels, perioperative remifentanil and postoperative opioid consumption and opioid-related side effects during the early recovery period.
This prospective, double-blind, split-body design study was conducted at Yeditepe University Faculty of Medicine, Plastic, Reconstructive, and Aesthetic Surgery Department, in collaboration with the Anesthesiology and Reanimation Department.
The anesthesia induction and PECS I blocks for the right breasts were performed by the same anesthesiologist in all patients (O.K.). Breast augmentation surgeries and local anesthetic infiltrations for the left breasts were performed by the same plastic surgeon (M.E.). Postoperative pain assessments were conducted by a different anesthesiologist who was blinded to the study design.
Postoperative pain was assessed using the Numeric Rating Scale (NRS), ranging from "0 = no pain" to "10 = unbearable pain." Pain assessments were performed every 30 minutes for the first 2 hours, every 2 hours between 2 and 6 hours, and at the 24ᵗʰ hour postoperatively.
- Conditions
- Breast Augmentation, Pain Management in Postoperative Care, Pain Management After Surgery, Pain Management
- Being tested
- PECS I Block, Local Anesthetic Infiltration
- Keywords
- breast augmentation, local infiltration, PECS 1 block, pectoral nerve block, postoperative pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS I BlockProcedure or surgery
The PECS I block is a regional anesthesia technique performed preoperatively under ultrasound guidance. It involves the injection of 10 mL of 0.5% bupivacaine between the pectoralis major and pectoralis minor muscles to block the medial and lateral pectoral nerves. This procedure targets the right breast in the study to reduce postoperative pain and is compared to local anesthetic infiltration.
Local Anesthetic InfiltrationProcedure or surgery
Local anesthetic infiltration involves the intraoperative administration of 10 mL of 0.5% bupivacaine under direct visualization into the pectoralis major muscle prior to muscle transection. This procedure targets the left breast in the study for pain management and is compared to the PECS I block.
| Study group | Role | What they receive |
|---|---|---|
| PECS I Block Intervention Arm | Experimental | This arm involves the application of a preoperative PECS I block with 10 mL of 0.5% bupivacaine under ultrasound guidance. The intervention targets the right breast, aiming to evaluate its effectiveness in managing postoperative pain compared to local anesthetic infiltration. Receives: Procedure: PECS I Block |
| Local Anesthetic Infiltration Intervention Arm | Experimental | This arm involves the administration of intraoperative local anesthetic infiltration using 10 mL of 0.5% bupivacaine under direct visualization. The intervention targets the left breast, aiming to compare its effectiveness in managing postoperative pain against the PECS I block. Receives: Procedure: Local Anesthetic Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
The level of postoperative pain in each breast region (right vs. left) measured using the Numeric Rating Scale (NRS). Pain scores will be recorded at specific intervals: every 30 minutes for the first 2 hours, every 2 hours from 2 to 6 hours, at the 24th hour, on the 5th postoperative day, and at the 3rd month. The primary focus is the pain intensity within the first 6 hours postoperatively.
Measured: Up to 6 hours post-surgery.
Secondary outcomes (4)
Opioid Consumption
Total tramadol consumption recorded within the first 6 hours and the first 24 hours postoperatively. This includes the amount administered via patient-controlled analgesia (PCA) and any additional doses required.
Measured: Up to 24 hours post-surgery.
Opioid-Related Side Effects
Incidence of opioid-related side effects such as nausea, vomiting, constipation, and respiratory depression. These will be monitored and recorded for each participant during the postoperative hospital stay
Measured: Up to 24 hours post-surgery
Chronic Pain Assessment
Presence of chronic pain in the breast region assessed using the Numeric Rating Scale (NRS) at the 3rd-month follow-up
Measured: At 3 months post-surgery
Postoperative Complications
Incidence of complications such as wound dehiscence, hematoma, infection, implant rupture, or sensory changes in the nipple. All complications will be recorded during routine follow-ups.
Measured: Up to 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start3 Oct 2024
- Primary completion3 Jan 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This study utilized a Crossover design with a split-body approach, where each participant served as their own control. The intervention involved two pain management techniques: PECS I block: Administered to the right breast by an anesthesiologist before surgery. Local anesthetic infiltration: Performed on the left breast by the plastic surgeon during surgery. This design allowed for direct comparison of the efficacy of the two interventions (PECS I block vs. local anesthetic infiltration) in managing postoperative pain within the same participant. The crossover and split-body methodology minimized inter-individual variability and provided robust data on the relative effectiveness of each technique, as all other surgical and anesthetic factors were standardized across both sides.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert Ersan, Yeditepe University Hospital
- Investigators
- Mert Ersan, Asst.Prof., Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719726
- Sponsor's protocol ID
- 2024-KAEK-21/1031
- Status last verified
- Jul 2025
- First submitted
- 3 Dec 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following specific individual participant data (IPD) will be shared: De-identified Participant Data: Demographic data (age, BMI, ASA classification). Pain scores measured using the Numeric Rating Scale (NRS) at predefined intervals. Postoperative opioid consumption (tramadol and morphine requirements). Incidence of postoperative complications (e.g., sensory changes, wound dehiscence). Data Dictionary: A comprehensive guide explaining the variables and coding used in the dataset to ensure accurate interpretation by other researchers. Exclusions: Personally identifiable information (e.g., names, contact information) will not be shared to maintain participant confidentiality. The data will be shared after the study is completed, analyzed, and the results are published in a peer-reviewed journal. Access will be granted only to researchers who provide a justified request and agree to the terms of a formal data-sharing agreement
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Preoperative PECS I Block and Intraoperative Local Anesthetic Infiltration for Postoperative Pain in Breast Augmentation: A Prospective, Double-Blind, Split-Body Study
- ClinicalTrials.gov ID
- NCT06719726
- Acronym / sponsor ID
- 2024-KAEK-21/1031
- Conditions
- Breast Augmentation, Pain Management in Postoperative Care, Pain Management After Surgery, Pain Management
- Keywords
- breast augmentation, local infiltration, PECS 1 block, pectoral nerve block, postoperative pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yeditepe University HospitalUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 6 Dec 2024 (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 aimed to compare the effectiveness of preoperative PECS I block and intraoperative local anesthetic infiltration in managing postoperative pain following breast augmentation surgery. The primary focus was to evaluate their impact on postoperative pain levels, perioperative remifentanil and postoperative opioid consumption and opioid-related side effects during the early recovery period.
Detailed description
Breast augmentation is one of the most performed procedures in aesthetic surgery worldwide.These techniques, which involve muscle dissection and manipulation, tend to be more painful compared to subglandular and subfascial placements. Thus, managing postoperative pain effectively becomes a critical aspect of patient recovery and satisfaction.
To address postoperative pain in breast augmentation, various techniques, including regional anesthesia such as pectoral nerve blocks, local anesthetic infiltration, and pocket irrigation, are employed.
This study aimed to compare the effectiveness of preoperative PECS I block and intraoperative local anesthetic infiltration in managing postoperative pain following breast augmentation surgery. The primary focus was to evaluate their impact on postoperative pain levels, perioperative remifentanil and postoperative opioid consumption and opioid-related side effects during the early recovery period.
This prospective, double-blind, split-body design study was conducted at Yeditepe University Faculty of Medicine, Plastic, Reconstructive, and Aesthetic Surgery Department, in collaboration with the Anesthesiology and Reanimation Department.
The anesthesia induction and PECS I blocks for the right breasts were performed by the same anesthesiologist in all patients (O.K.). Breast augmentation surgeries and local anesthetic infiltrations for the left breasts were performed by the same plastic surgeon (M.E.). Postoperative pain assessments were conducted by a different anesthesiologist who was blinded to the study design.
Postoperative pain was assessed using the Numeric Rating Scale (NRS), ranging from "0 = no pain" to "10 = unbearable pain." Pain assessments were performed every 30 minutes for the first 2 hours, every 2 hours between 2 and 6 hours, and at the 24ᵗʰ hour postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study utilized a Crossover design with a split-body approach, where each participant served as their own control. The intervention involved two pain management techniques: PECS I block: Administered to the right breast by an anesthesiologist before surgery. Local anesthetic infiltration: Performed on the left breast by the plastic surgeon during surgery. This design allowed for direct comparison of the efficacy of the two interventions (PECS I block vs. local anesthetic infiltration) in managing postoperative pain within the same participant. The crossover and split-body methodology minimized inter-individual variability and provided robust data on the relative effectiveness of each technique, as all other surgical and anesthetic factors were standardized across both sides.
| Arm | Type | Receives |
|---|---|---|
| PECS I Block Intervention Arm | Experimental | Procedure: PECS I BlockThis arm involves the application of a preoperative PECS I block with 10 mL of 0.5% bupivacaine under ultrasound guidance. The intervention targets the right breast, aiming to evaluate its effectiveness in managing postoperative pain compared to local anesthetic infiltration. |
| Local Anesthetic Infiltration Intervention Arm | Experimental | Procedure: Local Anesthetic InfiltrationThis arm involves the administration of intraoperative local anesthetic infiltration using 10 mL of 0.5% bupivacaine under direct visualization. The intervention targets the left breast, aiming to compare its effectiveness in managing postoperative pain against the PECS I block. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female participants aged 18 to 59 years.
- ASA (American Society of Anesthesiologists) physical status I or II.
- Scheduled for primary breast augmentation surgery using a dual-plane or submuscular approach.
- Planned to receive silicone implants of identical volume and shape for both breasts.
- Able to provide written informed consent.
Key exclusion criteria (10 listed)
- Planned subglandular or subfascial breast augmentation.
- Undergoing revision breast surgery.
- History of breast disease, previous breast or axillary surgery, or breast cancer.
- Preoperative breast pain or chronic pain syndromes (e.g., fibromyalgia, chronic headaches, back pain, complex regional pain syndrome, neuropathic pain, osteoarthritis, or radicular pain).
- BIRADS score > 3 based on imaging (ultrasound/mammography) within the past year.
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 |
|---|---|---|
| PECS I BlockThe PECS I block is a regional anesthesia technique performed preoperatively under ultrasound guidance. It involves the injection of 10 mL of 0.5% bupivacaine between the pectoralis major and pectoralis minor muscles to block the medial and lateral pectoral nerves. This procedure targets the right breast in the study to reduce postoperative pain and is compared to local anesthetic infiltration. | Procedure or surgery | PECS I Block Intervention Arm |
| Local Anesthetic InfiltrationLocal anesthetic infiltration involves the intraoperative administration of 10 mL of 0.5% bupivacaine under direct visualization into the pectoralis major muscle prior to muscle transection. This procedure targets the left breast in the study for pain management and is compared to the PECS I block. | Procedure or surgery | Local Anesthetic Infiltration Intervention Arm |
Primary outcome
Postoperative Pain Intensity
Time frame: Up to 6 hours post-surgery.
The level of postoperative pain in each breast region (right vs. left) measured using the Numeric Rating Scale (NRS). Pain scores will be recorded at specific intervals: every 30 minutes for the first 2 hours, every 2 hours from 2 to 6 hours, at the 24th hour, on the 5th postoperative day, and at the 3rd month. The primary focus is the pain intensity within the first 6 hours postoperatively.
4 secondary outcomes
Opioid Consumption
Time frame: Up to 24 hours post-surgery.
Opioid-Related Side Effects
Time frame: Up to 24 hours post-surgery
Chronic Pain Assessment
Time frame: At 3 months post-surgery
Postoperative Complications
Time frame: Up to 3 months post-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 16 Jul 2025.
- Individual participant dataSharing planned: Yes. The following specific individual participant data (IPD) will be shared: De-identified Participant Data: Demographic data (age, BMI, ASA classification). Pain scores measured using the Numeric Rating Scale (NRS) at predefined intervals. Postoperative opioid consumption (tramadol and morphine requirements). Incidence of postoperative complications (e.g., sensory changes, wound dehiscence). Data Dictionary: A comprehensive guide explaining the variables and coding used in the dataset to ensure accurate interpretation by other researchers. Exclusions: Personally identifiable information (e.g., names, contact information) will not be shared to maintain participant confidentiality. The data will be shared after the study is completed, analyzed, and the results are published in a peer-reviewed journal. Access will be granted only to researchers who provide a justified request and agree to the terms of a formal data-sharing agreement
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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.
Mert Ersan, Asst.Prof. principal investigator
Yeditepe 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 PECS I Block and Local Anesthetic Infiltration in people with Breast Augmentation and Pain Management in Postoperative Care, run by Yeditepe University Hospital 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 6 inclusion and 10 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 16 Jul 2025. 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?
Postoperative Pain Intensity (time frame: Up to 6 hours post-surgery.). 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 16 Jul 2025.