Health Trials

Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this trial

This study aims to evaluate the effect of serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-65 years

ASA physical status I-III

Scheduled for elective unilateral mastectomy with axillary lymph node dissection under general anesthesia

Able to understand and use the Numeric Rating Scale (NRS) for pain assessment

Disqualifiers

Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)

Coagulopathy, thrombocytopenia (<100,000/mm³), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued

Infection or skin lesion at the injection site

Planned bilateral surgery or additional major surgical procedures

Trial design

Design model

Parallel

Treatments tested in this trial

  • SPSIP Block With Bupivacaine

    Procedure/Surgery

    Participants will receive an ultrasound-guided SPSIP block using bupivacaine.

  • SPSIP Block With Saline

    Procedure/Surgery

    Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Serratus Posterior Superior Intercostal Plane Block GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

24-hour cumulative opioid consumption

Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.

Time frame
24 hours

Secondary outcomes

1

Static postoperative pain intensity at rest

Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
0, 1, 2, 6, 12, and 24 hours after surgery
2

Dynamic postoperative pain intensity during movement

Postoperative pain intensity during movement will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
0, 1, 2, 6, 12, and 24 hours after surgery
3

Rescue analgesia requirement

Number of patients requiring rescue analgesia and total rescue analgesic consumption.

Time frame
Within 24 hours after surgery
4

Time to first rescue analgesia

Time from the end of surgery to the first administration of rescue analgesia.

Time frame
Within 24 hours after surgery

Other outcomes

Sponsors and contacts

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

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Lead sponsor

Source ClinicalTrials.gov
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