Clinical trial · Interventional
Serratus Anterior Muscle Plane Block vsThoracic Paravertebral Block For Unilateral Mastectomies
Effectiveness of Serratus Anterior Muscle Plane Block With Thoracic Paravertebral Block For Unilateral Mastectomies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Critical study personnel left the institution
Summary
Brief summary (as posted)
HYPOTHESIS Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block (PVB) for acute pain control after unilateral mastectomies. SPECIFIC AIMS Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in patients undergoing unilateral mastectomy Secondary aim To compare the onset and duration of block and dermatomes blocked in both groups To compare the need of post-operative rescue analgesia in both groups. To compare the development of chronic incisional pain in both groups Functional outcome with respect to daily activities.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy | — | UNRESOLVED | — |
| Post Operative Pain | — | UNRESOLVED | — |
| Regional Anesthesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine | Drug | — | UNRESOLVED |
| Lidocaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Serratus Anterior Muscle Plane Block
- description
- The US probe will be placed in the mid-axillary line at the level of the 5th intercostal space. The latissimus dorsi, teres major and serratus muscles will be identified. Using in-plane approach, the block needle (22 G, 50 mm) will be inserted until the tip is visualized between the serratus anterior muscle and the intercostal muscles. As an extra reference point thoracodorsal artery will be used which aids in the identification of the plane superficial to the serratus muscle. After negative aspiration of blood, local anesthetic (20 ml of 0.25 % bupivacaine) will be injected and visualized in real-time.
- interventionNames
- Drug: Bupivacaine
- type
- ACTIVE_COMPARATOR
- label
- Thoracic Paravertebral Block
- description
- The spinous processes of T1- T5 will be identified and at parasagittal plan at 2.5 cm, skin wheel will be raised using 1% lidocaine. A 20-gauge, bevel needle will be advanced until the transverse process is located. The depth from skin to transverse process will be marked/identified by needle marking. The needle will be withdrawn 1-2 cm and angled down.The needle will be re-advanced 1cm past the initial marking. After negative aspiration, 4-5 ml of 0.25% bupivacaine will be slowly injected. The same procedure will be repeated at each level from T2 to T6 ensuring total dose of bupivacaine does not exceed the maximum dose recommended.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Simple or radical unilateral mastectomy with or without axillary lymph node dissection. * American Society of Anesthesia (ASA) I, II and III Exclusion Criteria: * Morbid obesity (body mass index \> 40 kg/m2); * Renal insufficiency (creatinine \> 2.0 mg/DL), * Current chronic analgesic therapy (daily use \> 4 weeks), * History of opioid dependence, pregnancy. * Allergy to local anesthetic * Rash/infection at the area of injection * Coagulation disorder * Patients on anticoagulation
References
Publications (0)
Data not yet available