Clinical trial · Interventional
Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block in Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction - a Non-inferiority Trial
Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block in Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction - a Non-inferiority Trial. A Single-centre Randomized Controlled Non-inferiority Trial With a Parallel Group Design
NCT05590559CI-TRIAL-00061617ESPunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The objective of this study is to assess the non-inferiority of analgesic efficacy of ESP vs PVB for patients undergoing unilateral mastectomy followed by immediate reconstruction.
Conditions
Conditions (1)
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 Patients Undergoing Mastectomy With Immediate Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Morphine | Drug | — | UNRESOLVED |
| Ultrasound-guided erector spinae plane block | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- paravertebral block
- interventionNames
- Drug: Morphine
- type
- EXPERIMENTAL
- label
- Ultrasound-guided erector spinae plane block
- interventionNames
- Other: Ultrasound-guided erector spinae plane block
Primary outcomes (2)
- measure
- Mean difference of highest numerical rating score (NRS - a linear 11 point scale for self-reported pain) during admission in the recovery room
- timeFrame
- 1 day
- measure
- Difference in the ratio of the means of cumulative opioid dose (administered during admission in the recovery room)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (18 years of age or older) * ASA I-III * Patients scheduled for elective unilateral mastectomy followed by direct reconstruction * Ability to give written and oral informed consent Exclusion Criteria: * Patient refusal * Non-elective surgery * Any contraindication to paravertebral block (including bleeding diathesis, coagulopathy, severe pulmonary disease ) * Allergy to amide-linked local anesthetics * Cardiac conductivity disorders (e:g: 2nd and 3rd AV-block) * Severe spinal malformations or history of extensive spine surgery - A history of spinal cord injury * Known psychiatric disorder * Chronic pain patients or patients already using opioids pre-operatively * Infection of the skin at the site of needle puncture area - Inability to give oral and written informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.