Clinical trial · Interventional
Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block
Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block, a Randomized Controlled Double Blinded Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer surgery is one of the most common surgeries, due to the high incidence of breast cancer. Unfortunately, patients experience significant postoperative acute pain, placing them at risk for increased clinical morbidity and the development of disabling chronic pain which may rich up to 55% . The intensity of perioperative pain experienced by the patient is one of the best predictors of chronic pain. However, postoperative analgesia in breast cancer surgery is difficult due to the extensive nature of the surgery and the complex innervation of the breast. Several newly described regional anesthesia techniques exist to control perioperative pain, including the Paravertebral block (PVB) which has been proved to be the most effective one. The anatomic proximity of the pleura and central neuraxial system makes it a particularly challenging technique and carrying a risk of pneumothorax. The Erector Spinae Plane Block (ESPB) is a novel interfascial plane block described by Forero et al in September 2016. Local anesthetic injection is performed beneath the erector spinae muscle. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally, blocking the dorsal and ventral rami of the spinal nerves.The easy, fast and safe execution of ESPB makes it a promising technique in the context of surgical pain during breast cancer surgery. There is no sufficient randomized controlled trials that assess the effectiveness of ESPB in controlling post-operative breast surgery pain. The main purpose of this study is to evaluate the postoperative analgesic effect of Ultrasound-guided ESPB in patients undergoing breast cancer surgery.
Conditions
Conditions (2)
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 Surgery | — | UNRESOLVED | — |
| Postoperative Analgesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erector spinae plane block | Procedure | — | UNRESOLVED |
| sham erector spinae plane block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- group B:ESP block
- description
- Patients in the experimental arm will receive an erector spinae plane block prior to induction of general anesthetic :- 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc) * An intravenous patient controlled analgesia device will be given to the patients postoperatively
- interventionNames
- Procedure: erector spinae plane block
- type
- PLACEBO_COMPARATOR
- label
- group P: Sham ESP block
- description
- Patients allocated to the placebo-control arm will receive a sham erector spinae plane block .they will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block:- 40 cc of normal saline will be injected -An intravenous patient controlled analgesia device will be given to the patients postoperatively
- interventionNames
- Procedure: sham erector spinae plane block
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 25-65 years old * ASA I-II * Undergoing unilateral breast cancer surgery Exclusion Criteria: * obesity (body mass index \>40 kg/m2) * Preoperative chronic dependence upon opioid and NSAID medications * History of psychiatric or neurological disease * Patients with chronic pain syndromes * allergy to local anaesthetics * other contraindications to peripheral nerve blocks * Patients' refusal to participate
References
Publications (0)
Data not yet available