Comparing two ultrasound-guided chest wall nerve blocks for pain after mastectomy
Mastektomi Planlanan Hastalarda Serratus Posterior Superior İnterkostal Plan Bloğu Ile Serratus Anterior Plan Bloğunun Peroperatif Analjezi Yönetimi Üzerine Etkilerinin Araştırılması
NA · Uludag University · NCT07510269
This study will see if one of two ultrasound-guided chest wall nerve blocks gives better pain relief and less opioid use for women having an elective mastectomy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Uludag University (other) |
| Locations | 1 site (Bursa, Nilüfer) |
| Trial ID | NCT07510269 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial will enroll female patients aged 18–75 with ASA physical status I–III who are scheduled for elective mastectomy and provide informed consent. Participants will be randomly assigned to receive either an ultrasound-guided serratus anterior plane (SAP) block or a serratus posterior superior intercostal plane (SPSIP) block prior to standardized general anesthesia. Postoperative pain scores, opioid consumption, and recovery outcomes will be tracked using a standardized perioperative analgesia protocol. The trial compares two interfascial plane regional anesthesia techniques to determine differences in analgesic effectiveness and side-effect profiles.
Who should consider this trial
Good fit: Women aged 18–75 years with ASA physical status I–III scheduled for elective mastectomy who can give informed consent and have no contraindication to regional anesthesia.
Not a fit: Patients with ASA IV/V, active coagulopathy or anticoagulation, allergy to local anesthetics, chronic opioid use, severe organ failure, pregnancy, or local infection at the block site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, one block could provide better postoperative pain relief and reduce opioid use, improving comfort and recovery after mastectomy.
How similar studies have performed: Previous studies of serratus anterior and other interfascial plane blocks have shown reduced pain and opioid requirements after breast and thoracic surgery, but direct comparisons between SAP and SPSIP are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged between 18 and 75 years * Patients scheduled for elective mastectomy surgery * American Society of Anesthesiologists (ASA) physical status I-III * Patients who provide written informed consent Exclusion Criteria: * Patients who refuse to participate in the study * Patients with American Society of Anesthesiologists (ASA) physical status IV or V * Patients receiving anticoagulant therapy or with suspected coagulopathy * Patients with known allergy to local anesthetic agents * Infection at the site of block application * Pregnant patients or those with suspected pregnancy * Patients with severe neurological or psychiatric disorders * Patients with severe cardiovascular disease * Patients with chronic opioid use * Patients with hepatic failure or renal failure (glomerular filtration rate \<15 mL/min/1.73 m²)
Where this trial is running
Bursa, Nilüfer
- Bursa Uludag University Hospital — Bursa, Nilüfer, Turkey (Türkiye) (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Pain, Nerve Block, Mastectomy, Patient Outcome Assessment, Serratus Posterior Superior Intercostal Plane Block, Serratus Anterior Plane Block, Multimodal Analgesia, Mastectomy Surgery