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ESPB Versus Intravenous Lidocaine for Pain After Mastopexy

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Start date changed from estimate of Jul 2026 to Jul 1, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised
    • Study description expanded, about 3 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Elective breast reduction surgery is associated with moderate-to-severe postoperative pain and a risk of developing chronic postsurgical pain. Enhanced Recovery After Surgery (ERAS) protocols and the Procedure-Specific Postoperative Pain Management (PROSPECT) guidelines emphasize the importance of multimodal analgesia to reduce pain, minimize opioid consumption, and accelerate functional recovery following surgical procedures, including breast surgery. The erector spinae plane block (ESPB) has demonstrated effectiveness in breast reduction surgery by reducing postoperative pain intensity, perioperative opioid and non-opioid analgesic consumption, and improving patient satisfaction and recovery time. Furthermore, the use of ESPB has been associated with a reduced incidence of postoperative nausea and vomiting. ESPB is performed with the patient in the sitting position and involves ultrasound-guided identification of the vertebral transverse processes on the side of the block, typically in the interscapular region, followed by the injection of approximately 20 mL of local anesthetic adjacent to the transverse process. When required, the procedure is performed bilaterally at the same vertebral level. ESPB is considered one of the simplest regional anesthesia techniques to perform. Intravenous lidocaine infusion has been shown to significantly reduce opioid requirements and postoperative pain intensity across a wide range of surgical procedures, particularly in abdominal and breast surgery. Moreover, intraoperative lidocaine infusion has been associated with a reduced risk of chronic postsurgical pain following breast surgery. This study was designed to investigate whether intraoperative intravenous lidocaine infusion is non-inferior to ESPB in reducing postoperative pain and improving the quality of recovery following non-oncological breast reduction surgery. Intravenous lidocaine infusion may provide analgesic efficacy and recovery outcomes comparable to those achieved with ESPB, thereby representing a less invasive alternative within a multimodal analgesic strategy.
Trial Details
NCT Number NCT07687069
Lead Sponsor Centre of Postgraduate Medical Education
Conditions
(from sponsor)
Breast Hypertrophy
Related terms Gigantomastia, Postoperative Pain
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov