Postoperative Pain After Breast Augmentation SurgeryNCT07879053
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
A study testing Ultrasound-Guided PECS II Block and Standard multimodal analgesia in people with Postoperative Pain After Breast Augmentation Surgery and Postoperative Analgesia, run by Ergun Gunduz.
Trial summary
This randomized, controlled clinical study will evaluate the effect of an ultrasound-guided PECS II block on postoperative pain control in patients undergoing elective augmentation mammoplasty. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
- What is being tested?
- Ultrasound-Guided PECS II Block and Standard multimodal analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2026to 30 Nov 2026
- Phase
- Interventional
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
- Female patients aged 18 to 65 years.
- Patients scheduled for elective breast augmentation surgery.
- Body weight of 40 kg or greater.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Ability and willingness to provide written informed consent to participate in the study.
Who cannot join
- Refusal to participate in the study.
- Serious cardiac disease.
- Previous breast surgery.
- History of chronic pain.
- Neuromuscular disease.
- Cognitive impairment or active psychiatric illness that may interfere with study -participation or outcome assessment.
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- Infection at the surgical or block injection site.
- Coagulation disorder.
- Known allergy or hypersensitivity to local anesthetic agents, including bupivacaine.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Adding Ultrasound-Guided Pectoral Nerve Block (PECS II) to Standard Multimodal Analgesia in Breast Augmentation Surgery: A Randomized, Double-Blind, Controlled Trial
This randomized, controlled clinical study will evaluate the effect of an ultrasound-guided PECS II block on postoperative pain control in patients undergoing elective augmentation mammoplasty.
A total of 50 adult female patients aged 18-65 years who meet the eligibility criteria and provide written informed consent are planned to be enrolled. Participants will be randomly assigned to two groups using a computer-generated randomization method.
Read more
Participants in the PECS II group will receive an ultrasound-guided PECS II block after induction of general anesthesia and before surgical incision, in addition to standard postoperative multimodal analgesia. Participants in the control group will receive standard postoperative multimodal analgesia without a PECS II block or placebo procedure.
The primary objective is to evaluate postoperative pain intensity using the visual analog scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes will include analgesic consumption, additional analgesic requirements, postoperative nausea and vomiting, and potential complications associated with the block.
Outcomes will be compared between the two groups to assess the effect of the PECS II block on postoperative pain control.
Read the detailed description
This is a prospective, randomized, controlled, parallel-group clinical study designed to evaluate the effect of an ultrasound-guided PECS II block on postoperative analgesia in patients undergoing elective augmentation mammoplasty.
Eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to two groups using a computer-generated randomization method. The randomization sequence will be generated by an independent researcher, and allocation concealment will be maintained using sealed envelopes.
Participants in the PECS II block group will receive an ultrasound-guided PECS II block after induction of general anesthesia and before surgical incision. Bupivacaine will be administered under aseptic conditions at the concentration and volume specified in the study protocol. Participants in the control group will not receive a PECS II block or a placebo procedure.
Both groups will receive standard general anesthesia and the same postoperative multimodal analgesia protocol, consisting of paracetamol, nonsteroidal anti-inflammatory drugs, and opioids as needed. Remifentanil infusion will be used intraoperatively, with dose titration according to clinical requirements.
Participants, the surgeon, and the investigator responsible for postoperative outcome assessment will be blinded to group allocation. The anesthesiologist performing the PECS II block will be aware of the intervention assignment. Postoperative assessments will be performed by an investigator who is blinded to group allocation.
Intraoperative and postoperative data will be collected on pain intensity, analgesic consumption, additional analgesic requirements, postoperative nausea and vomiting, and potential complications associated with the block. The collected data will be compared between the two groups using appropriate statistical methods. The study will be conducted following approval by the relevant ethics committee and in accordance with applicable ethical principles.
- Being tested
- Ultrasound-Guided PECS II Block, Standard multimodal analgesia
- Keywords
- Breast Augmentation Surgery, Breast Surgery, Multimodal Analgesia, Regional Anesthesia, PECS II Block Pectoral Nerve Block Ultrasound-Guided, Postoperative Pain, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided PECS II BlockProcedure or surgery
An ultrasound-guided PECS II block will be performed after induction of general anesthesia and before surgical incision. Bupivacaine will be administered under aseptic conditions at the concentration and volume specified in the study protocol.
Standard multimodal analgesiaOther
Standard multimodal analgesia will be administered according to the study protocol. The regimen will include the specified analgesic medications, with additional rescue analgesia administered when clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| PECS II Block Group | Experimental | Participants undergoing elective breast augmentation surgery will receive an ultrasound-guided PECS II block after induction of general anesthesia and before surgical incision, in addition to the standard multimodal analgesia regimen. Bupivacaine will be administered according to the study protocol. Postoperative pain scores and additional analgesic requirements will be recorded. Receives: Procedure: Ultrasound-Guided PECS II Block; Other: Standard multimodal analgesia |
| Control Group | Active comparator | Participants undergoing elective breast augmentation surgery will receive standard general anesthesia and the standard multimodal analgesia regimen. No PECS II block or placebo procedure will be performed. Postoperative pain scores and additional analgesic requirements will be recorded. Receives: Other: Standard multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 1, 6, 12, and 24 hours after surgery. VAS scores will be compared between the PECS II block group and the control group.
Measured: 1, 6, 12, and 24 hours after surgery
Secondary outcomes (1)
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 1, 6, 12, and 24 hours after surgery. VAS scores will be compared between the PECS II block group and the control group.
Measured: 1, 6, 12, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start22 Sep 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain After Breast Augmentation SurgeryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups using a computer-generated randomization method. The PECS II group will receive an ultrasound-guided PECS II block in addition to standard multimodal analgesia, whereas the control group will receive standard multimodal analgesia alone. Postoperative outcomes will be compared between the two groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ergun Gunduz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ergun Gunduz, Atlas University
- Investigators
- Ergun Gunduz, MD, Principal investigator, Istanbul Atlas University Faculty of Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879053
- Sponsor's protocol ID
- PECS II 05/01
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Study data will be used for the purposes of the present study and will be handled confidentially in accordance with applicable ethical and data protection requirements.
Publications
Chin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.
PubMed 33426660Chin KJ, Lirk P, Hollmann MW, Schwarz SKW. Mechanisms of action of fascial plane blocks: a narrative review. Reg Anesth Pain Med. 2021 Jul;46(7):618-628. doi: 10.1136/rapm-2020-102305.
PubMed 34145073