ltrasound-guided erector spinae plane block versus paravertebral block in breast cancer patients undergoing mastectomy with immediate reconstruction – a non-inferiority trial.

Conditions: mastectomy with immediate reconstruction

Registration Number: NL-OMON26286

Lead Sponsor: Department Anesthesiology Antoni van Leeuwenhoek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 200

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 anaesthetics
-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Mean difference in highest numerical rating score (NRS – a linear 11 point scale for self-reported pain) during admission in the recovery room<br>-Difference in the ratio of the mean cumulative intravenous opioid dose administered during admission in the recovery room – converted to morphine equivalent dose (MEQ)

Secondary Outcome Measures

Name	Time	Method
-Success rate as defined by satisfactory spread of local anaesthetic agents on ultrasound <br>-Ease of procedure (self-reported by performer of block on scale of 1 - 5)<br>-Total opioid dose administered on day 0 and on day 1 (converted to morphine equivalent dose (MEQ) <br>-Highest reported NRS on day 0 and 1<br>-Incidence of complications of block (such as block failure, epidural hematoma, hemo- or pneumothorax and symptoms of toxicity of local anesthetics)<br>-Patient satisfaction on a scale of 0 (extremely unsatisfied) tot 10 (extremely satisfied)