ESPB Versus Intravenous Lidocaine for Pain After Mastopexy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCentre of Postgraduate Medical Education

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA physical status I-III

Scheduled for elective breast reduction surgery for non-oncological indications

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound - guided Erector Spine Plane Block (ESPB)

    Procedure/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).

  • Intraoperative intravenous lidocaine infusion

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Erector spine plane block (ESPB)Experimental treatment 1 intervention
Group B: Lidocaine infusionExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
48 hours

Secondary outcomes

1

Postoperative opioid consumption

Total consumption of rescue opioid analgesia (buprenorphine) during the first 24 postoperative hours

Time frame
24 hours
2

Postoperative pain intensity 2 hours

Pain intensity assessed by Numeric Rating Scale (0-10) 2 hours after completion of surgery

Time frame
2 hours
3

Postoperative pain intensity 4 hours

Pain intensity assessed by Numeric Rating Scale (0-10) 4 hours after completion of surgery

Time frame
4 hours
4

Postoperative pain intensity 8 hours

Pain intensity assessed by Numeric Rating Scale (0-10) 8 hours after completion of surgery

Time frame
8 hours

Other outcomes

Sponsors and contacts

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