Clinical trial · Interventional
Erector Spinae Block vs. Placebo Block Study
Quality of Recovery Scores Following Erector Spinae Block vs. Sham Block in Ambulatory Breast Cancer Surgery: A Randomised Controlled 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)
Regional anaesthesia combined with general anaesthesia has become common in the perioperative management of breast cancer surgery patients. Regional techniques have been recognised to provide excellent post-operative analgesia. It enhances multi-modal analgesia regimes while being opioid sparing, reducing incidence of post-operative nausea and vomiting and allowing earlier mobilisation/discharge and improving treatment success. Therefore identifying the correct regional anaesthetic technique for this group of patients is important in providing optimum peri-operative care.
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 |
| Nerve Block | — | UNRESOLVED | — |
| Neuromuscular Blockade | — | UNRESOLVED | — |
| Regional Anesthesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erector spinae plane block | Procedure | — | UNRESOLVED |
| Placebo Block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- Patients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block (see above) under ultrasound guidance to stimulate a real block procedure.
- interventionNames
- Procedure: Placebo Block
- type
- EXPERIMENTAL
- label
- Erector spinae plane (ESP) block group
- description
- Local anaesthetic infiltration utilising 1% lidocaine will occur, and an 80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed.
- interventionNames
- Procedure: Erector spinae plane block
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * ASA classification: I-III * BMI \< 35 kg/m2 * Day surgery procedure Exclusion Criteria: * Prior ipsilateral breast surgery, excluding lumpectomy * Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest * Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases * Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma) * Contraindication to regional anaesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest) * Patient refusal * Chronic pain disorder * Chronic opioid use (≥30 mg oxycodone / day) * Contraindication (or allergy) to a component of multi-modal analgesia protocol * Allergy to amide local anaesthetics used in nerve blocks * Contraindications to any of the components of the standardized general anaesthesia * Significant psychiatric disorder that would preclude objective study assessment * Pregnancy/ women with nursing infants * Unable to provide informed consent * Unable to speak and read English
References
Publications (0)
Data not yet available