Breast Cancer
Conditions
Keywords
mastectomy
Brief summary
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
Detailed description
This study is a prospective, randomized, placebo-controlled, multicenter clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing mastectomy with axillary lymph node dissection. Postoperative pain following breast surgery is often significant and may increase opioid consumption and related adverse effects, highlighting the need for effective regional anesthesia techniques. The SPSIP block is a novel ultrasound-guided interfascial plane block with emerging evidence in thoracic and chest wall procedures; however, its role in breast surgery remains unclear, particularly in placebo-controlled settings. This study aims to determine whether the SPSIP block provides additional benefit as part of a standardized multimodal analgesia approach. Participants will be randomly assigned to receive either SPSIP block with local anesthetic or a placebo intervention under identical conditions, with blinding applied to all relevant parties. All patients will receive the same perioperative anesthesia and analgesia protocol. The results of this study are expected to clarify the clinical value of SPSIP block in breast surgery and contribute to the development of evidence-based postoperative pain management strategies.
Interventions
PROCEDURESPSIP Block With Bupivacaine
Participants will receive an ultrasound-guided SPSIP block using bupivacaine.
PROCEDURESPSIP Block With Saline
Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Study solutions (local anesthetic or saline) will be prepared by an independent anesthesiologist not involved in patient care or data collection. Syringes will be identical in appearance, volume, and labeling. Randomization assignments will be concealed using sealed opaque envelopes.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the SPSIP block group or the placebo group using a computer-generated randomization sequence. Both groups will receive identical perioperative management, and outcomes will be compared between parallel groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Provided written informed consent
Exclusion criteria
* 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 * Chronic pain conditions or regular use of opioids, gabapentinoids, or centrally acting analgesics * Neurological or psychiatric conditions interfering with pain assessment * History of previous major thoracic or chest wall surgery on the same side * Pregnancy or breastfeeding * Refusal to participate or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour cumulative opioid consumption | 24 hours | Total opioid consumption within the first 24 hours after surgery, recorded in milligrams. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Static postoperative pain intensity at rest | 0, 1, 2, 6, 12, and 24 hours after surgery | 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. |
| Dynamic postoperative pain intensity during movement | 0, 1, 2, 6, 12, and 24 hours after surgery | 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. |
| Rescue analgesia requirement | Within 24 hours after surgery | Number of patients requiring rescue analgesia and total rescue analgesic consumption. |
| Time to first rescue analgesia | Within 24 hours after surgery | Time from the end of surgery to the first administration of rescue analgesia. |
| Incidence of postoperative nausea and vomiting (PONV) | Within 24 hours after surgery | Occurrence of nausea and/or vomiting during the postoperative period. |
| Quality of Recovery-15 (QoR-15) score | 24 hours after surgery | Quality of recovery assessed using the QoR-15 questionnaire. Quality of Recovery-15 (QoR-15) questionnaire was used to assess postoperative recovery. The total score ranges from a minimum of 0 to a maximum of 150. A higher score represents a better recovery outcome (0 = extremely poor recovery, 150 = excellent recovery) |
| Block-related and opioid-related adverse events | Within 24 hours after surgery | Incidence of adverse events including local anesthetic toxicity, hematoma, infection, and opioid-related side effects. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFatma Acil, M.D.
PRINCIPAL_INVESTIGATORFatma Acil, M.D.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Outcome results
None listed