Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block in Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction - a Non-inferiority Trial

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Treatments: Morphine

Criteria

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