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Not Yet Recruiting NCT07879053

Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery

Conditions: Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia

Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Ergun Gunduz

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. 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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Infection at the surgical or block injection site. * Coagulation disorder. * Known allergy or hypersensitivity to local anesthetic agents, including bupivacaine.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07879053). StuddyBuddy aggregates publicly available trial information.