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

Recruiting

Conditions: Breast cancer
10006295

Registration Number: NL-OMON50985

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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
<p>- Mean difference of highest numerical rating score (NRS - a linear 11 point<br /><br>scale for self-reported pain) during admission in the recovery room<br /><br>- Difference in the ratio of the means of cumulative opioid dose (administered<br /><br>during admission in the recovery room)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Success rate as defined by satisfactory spread of local anaesthetic agents on<br /><br>ultrasound<br /><br>- Ease of procedure (self-reported by anaesthetist on scale of 1-5)<br /><br>- Total opioid dose administered on day 0 and on day 1 (iv, subcutaneous or<br /><br>oral - converted to morphine equivalent dose (MEQ)<br /><br>- Highest pain score on day 0 and 1<br /><br>- Time to readiness for discharge from the recovery room<br /><br>- Complications of block (such as block failure, epidural hematoma, hemo- or<br /><br>pneumothorax and symptoms of toxicity of local anesthetics)<br /><br>- Patient satisfaction on a scale of 0 (extremely unsatisfied) tot 10<br /><br>(extremely satisfied)</p><br>