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ESPB Versus Intravenous Lidocaine for Pain After Mastopexy

NCT07687069 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-07

No results posted yet for this study

Summary

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.

Conditions

  • Breast Hypertrophy

Interventions

PROCEDURE

Ultrasound - guided Erector Spine Plane Block (ESPB)

Bilateral ultrasound - guided ESPB will be performed before induction of anesthesia using 20 mL of 0.25% bupivacaine per side (total volume 40 mL).

PROCEDURE

Intraoperative intravenous lidocaine infusion

Patients will receive an intravenous lidocaine bolus of 1.5 mg/kg over 10 minutes before induction of anesthesia, followed by a continuous infusion of 1.5 mg/kg/h (0.15 mL/kg/h) until placement of the final skin suture.

Sponsors & Collaborators

  • Centre of Postgraduate Medical Education

    lead OTHER

Principal Investigators

  • Małgorzata Malec-Milewska, MD, Prof. · Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-07-31
Completion
2028-08-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07687069 on ClinicalTrials.gov