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Erector Spinae Plane Block (ESPB) Versus Intravenous Lidocaine Infusion for Postoperative Pain and Quality of Recovery in Patients Undergoing Breast Reduction Surgery: A Single Center, Prospective, Randomized Study.
Sponsor study identifier
interventional
80
1 country
1
Study Start
July 1, 2026
Actual (reported)Primary Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2026
Actual (reported)July 1, 2026
Actual (reported)July 7, 2026
Actual (reported)July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Bilateral ESPB performed before induction of anesthesia
Intravenous lidocaine bolus infusion started before induction of anesthesia and continued until the end of surgery
Bilateral ultrasound - guided ESPB will be performed before induction of anesthesia using 20 mL of 0.25% bupivacaine per side (total volume 40 mL).
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.
Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care
Warsaw, 01-813, Poland
Małgorzata Malec-Milewska, MD, Prof.
Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw
Katarzyna Białowolska-Horosz, MD,PhD
CONTACT
First Submitted
June 19, 2026
First Posted
July 7, 2026
Study Start
July 1, 2026
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 9, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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