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. - The ESP study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50985

Enrollment

100

Registered

2021-05-04

Start date

2021-09-30

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Pre-operative ultrasound guided single shot paravertebral block versus ultrasound guided single shot erector spinae plane block.

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
- Mean difference of highest numerical rating score (NRS - a linear 11 point scale for self-reported pain) during admission in the recovery room - Difference in the ratio of the means of cumulative opioid dose (administered during admission in the recovery room)	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)