SPSIP Block Versus ESP Block for Chronic Pain After Unilateral Breast Surgery

ConditionsPostoperative Pain Opioid Use

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-65

SponsorEngin Çetin

About this trial

This prospective, randomized, assessor-blinded study will compare serratus posterior superior intercostal plane block and erector spinae plane block in adult female patients undergoing unilateral breast surgery. The primary outcome is chronic postoperative pain at 3 months, assessed using the Brief Pain Inventory-Short Form.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-65 years

ASA physical status I-III

Body mass index (BMI) between 18 and 35 kg/m²

Scheduled for elective unilateral breast surgery (mastectomy with or without sentinel lymph node biopsy)

Disqualifiers

Infection at the site of block application

Known allergy to local anesthetics

Coagulopathy or anticoagulant therapy

Chronic opioid use

Trial design

Design model

Parallel

Treatments tested in this trial

Serratus Posterior Superior Intercostal Plane Block
Procedure/Surgery
An ultrasound-guided interfascial plane block performed between the serratus posterior superior muscle and the underlying ribs prior to general anesthesia.
Ultrasound-guided Erector Spinae Plane Block
Procedure/Surgery
An ultrasound-guided erector spinae plane block performed prior to induction of general anesthesia using 30 mL of 0.25% bupivacaine.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: SPSIP BlockActive comparator 1 intervention

Group B: ESPB BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form

Chronic postoperative pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF assesses pain severity (worst, least, average, and current pain) and pain interference with daily activities. Pain severity items are scored on a 0-10 numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Pain interference items are scored on a 0-10 numeric rating scale (0 = does not interfere; 10 = completely interferes). Higher scores indicate worse pain severity and greater pain-related interference.

Time frame

Time Frame: T0: 3 months postoperatively

Secondary outcomes

Neuropathic Pain Assessed by the DN4 Questionnaire

Neuropathic pain will be assessed using the Douleur Neuropathique 4 Questions (DN4) questionnaire. The DN4 consists of 10 items with a total score ranging from 0 to 10 (0 = no neuropathic pain characteristics; 10 = all neuropathic pain characteristics present). Higher scores indicate a greater likelihood of neuropathic pain. A total score of 4 or higher is considered indicative of neuropathic pain.

Time frame

T0: 3 months postoperatively

Sponsors and contacts

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

Engin Çetin

Lead sponsor

Kocaeli City Hospital

Sponsor institution

Source ClinicalTrials.gov

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