ESPB Versus Intravenous Lidocaine for Pain After Mastopexy

NCT07687069 | Not Yet Recruiting

• 1 other identifier: ESPB for mastopexy
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast reduction; postoperative pain; erector spine plane block; lidocaine; pain modulation

Outcome Measures

Primary Outcomes (1)

• Quality of recovery following breast reduction surgery

  Quality of Recovery score measured using the Quality of Recovery-15 questionnaire (QoR-15, 0 - 150, where 0 indicates very poor recovery and 150 indicates excellent recovery), assessed at least 24 hours after completion of surgery.

  48 hours

Secondary Outcomes (9)

• Postoperative opioid consumption

  24 hours

• Postoperative pain intensity 2 hours

  2 hours

• Postoperative pain intensity 4 hours

  4 hours

• Postoperative pain intensity 8 hours

  8 hours

• Postoperative pain intensity 24 hours

  24 hours

Study Arms (2)

Erector spine plane block (ESPB)

EXPERIMENTAL

Bilateral ESPB performed before induction of anesthesia

Procedure: Ultrasound - guided Erector Spine Plane Block (ESPB)

Lidocaine infusion

EXPERIMENTAL

Intravenous lidocaine bolus infusion started before induction of anesthesia and continued until the end of surgery

Procedure: Intraoperative intravenous lidocaine infusion

Interventions

Ultrasound - guided Erector Spine Plane Block (ESPB) PROCEDURE

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

Erector spine plane block (ESPB)

Intraoperative intravenous lidocaine infusion PROCEDURE

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.

Lidocaine infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III
• Scheduled for elective breast reduction surgery for non-oncological indications

You may not qualify if:

• Refusal or inability to provide written informed consent
• History of chronic somatic or neuropathic pain
• Current psychiatric disorders or ongoing treatment with antidepressant medications
• Poorly controlled cardiovascular disease
• Known allergy or intolerance to amide local anesthetics, including lidocaine and bupivacaine
• Current alcohol abuse or substance use disorder

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care

Warsaw, 01-813, Poland

Location

MeSH Terms

Conditions

Gigantomastia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Małgorzata Malec-Milewska, MD, Prof.

  Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

  STUDY CHAIR

Central Study Contacts

Bartosz Horosz, MD,PhD

CONTACT

0048225841122; bartosz.horosz@gmail.com

Katarzyna Białowolska-Horosz, MD,PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessment of the outcomes is performed by investigator blinded to type of intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Model Details: Prospective, randomized

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

PL (1)