Fatma Acil
Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07579650
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
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive an ultrasound-guided SPSIP block using bupivacaine.
Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.
Time frame: 24 hours
Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.
Time frame: 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.
Time frame: 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.
Time frame: Within 24 hours after surgery
Number of patients requiring rescue analgesia and total rescue analgesic consumption.
Time frame: Within 24 hours after surgery
Time from the end of surgery to the first administration of rescue analgesia.
Time frame: Within 24 hours after surgery
Occurrence of nausea and/or vomiting during the postoperative period.
Time frame: 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)
Time frame: Within 24 hours after surgery
Incidence of adverse events including local anesthetic toxicity, hematoma, infection, and opioid-related side effects.
Contact information is provided by the study sponsor or research team.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Other
Mastectomy and Axillary Dissection: Evaluation of the Effect of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia: A Multicenter, Randomized, Placebo-Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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