An interventional study of Ultrasound-Guided PECS II Block and Standard multimodal analgesia in Postoperative Pain After Breast Augmentation Surgery and Postoperative Analgesia, sponsored by Ergun Gunduz. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Ergun Gunduz · Not applicable, Interventional, and Treatment
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.
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.
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 50 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
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.
Procedure: Ultrasound-Guided PECS II Block · Other: Standard multimodal analgesia
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.
Other: Standard multimodal analgesia
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 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.
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.
Time frame: 1, 6, 12, and 24 hours after surgery
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.
Time frame: 1, 6, 12, and 24 hours after surgery
No study locations are listed for this record.
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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