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Effect of Continuous Erector Spinae Plane Block With Ropivacaine on Postoperative Pain and NF-κB Levels After Mastectomy

ConditionsBreast CancerPostoperative Pain, Acute
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorAldy Aldy

About this trial

This study aims to evaluate the effect of continuous erector spinae plane block (CESPB) using ropivacaine on postoperative pain in patients undergoing elective mastectomy. In addition to pain control, this study investigates the impact of CESPB on systemic inflammatory response as measured by nuclear factor kappa B (NF-κB) levels, opioid consumption, and quality of recovery. Patients will be randomly assigned to receive CESPB or standard analgesia without block. Outcomes will be assessed within the first 24 hours after surgery. The findings are expected to provide evidence on the clinical and biological benefits of CESPB as part of multimodal analgesia in breast surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18 to 65 years

Diagnosed with breast cancer

Scheduled for elective mastectomy under general anesthesia

American Society of Anesthesiologists (ASA) physical status I-III

Disqualifiers

Contraindications to regional anesthesia

Contraindications or allergy to ropivacaine or local anesthetics

Inability to use a visual analog scale (VAS) for pain assessment

Inability to understand or operate patient-controlled analgesia (PCA)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous Erector Spinae Plane Block

    Procedure/Surgery

    Ultrasound-guided placement of a catheter in the erector spinae plane for continuous regional analgesia.

  • Ropivacaine

    Drug

    Local anesthetic administered via continuous infusion through the erector spinae plane catheter for postoperative analgesia.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Continuous Erector Spinae Plane Block With RopivacaineExperimental treatment 2 interventions
Group B: Standard Analgesia Without BlockNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Postoperative Pain Intensity

Postoperative pain intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where higher scores indicate greater pain.

Time frame
24 hours after surgery

Secondary outcomes

1

Change in Nuclear Factor Kappa B Levels From Baseline

Change in nuclear factor kappa B (NF-κB) levels from baseline to 24 hours after surgery, measured in blood samples to assess systemic inflammatory response.

Time frame
Baseline and 24 hours after surgery
2

Opioid Consumption

Total opioid consumption within the first 24 hours after surgery, converted to morphine equivalent dose.

Time frame
24 hours after surgery
3

Quality of Recovery

Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, with higher scores indicating better recovery.

Time frame
24 hours after surgery
4

Postoperative Nausea and Vomiting

Incidence of postoperative nausea and vomiting within the first 24 hours after surgery.

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aldy Aldy

Lead sponsor

Udayana University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: