High versus low dose serratus anterior plane block after minimally invasive valve surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Jessa Ziekenhuis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Decision date (initial)

2024-02-12

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

We hypothesize a 25% reduction in opioid consumption in patients randomized to the high dose local anesthesia intervention arm towards patients in the control arm.

Secondary objectives 1

1. Secondly, we hypothesize a trend towards differences in secondary outcome parameters and we hypothesize serum bupivacaine levels to not exceed toxic levels after Serratus Anterior Plane Block.

Conditions and MedDRA coding

Serratus anterior plane block after an aortic valve replacement

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Scheduled for elective aortic valve surgery or elective mitral valve surgery via right anterolateral thoracotomy
2. Adult patients (minimally 18 years old)
3. EuroScore ii < 3%

Exclusion criteria 12

1. Refusal to participate
2. Inability to communicate due to language or neurologic barriers
3. Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties
4. Chronic use of analgesic antidepressants and/or antiepileptics
5. Chronic use of opioids
6. History of major trauma or surgery to right chest wall
7. History of chronic pain at right chest wall
8. Allergy to opioids and/or local anesthetics
9. Allergy to acetaminophen
10. Class 3 obesity (BMI 40 or more)
11. Intraoperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, ..)
12. Pregnancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Cumulative morphine consumption by PCIA at 24 hours after block placement. Information on morphine consumption will extracted from the PCIA-system after 24 hours and analyzed using 4-hour intervals.

Secondary endpoints 13

1. Opioid consumption will be evaluated at predetermined time intervals after performing the Serratus anterior plane block (0-4h, 4-8h, 8-12h, 12-16h, 16-20h, and 20-24h)
2. Number of patients that do not require any additional PCIA opioids within the first 24 hours after block placement.
3. The postoperative pain on the surgical site is evaluated based on a 11-points numeric scale (Numerical Rating Sale - NRS) where 0 = no pain and 10 = worst pain ever. The NRS pain score in rest as well as with deep respiration is assessed at 4 hours, 8 hours, 12 hours and 24 hours after performing the Serratus Anterion Plane Block and at POD 7.
4. Overall patient satisfaction with analgesic therapy will be assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied) 24h after performing the Serratus Anterior Plane Block at POD 1.
5. Time from arrival to the ICU until extubation in minutes.
6. Time from arrival to the ICU until first mobilization. According to our ERACS protocol, active patient mobilization is intended at six hours after surgery on the conditions that patients are extubated, chest tube drainage is low (<50ml/h) and patients are comfortable.
7. The simplified PONV impact scale will be used to assess PONV 24h after performing the SAP block at POD 1. Clinically important PONV will be defined as a score of 5 or more.
8. Time to first defecation (postoperative days) or need for laxatives during hospital stay (number of patients)
9. Time from arrival to the ICU until meeting discharge criteria to the ward in postoperative hours.
10. Time to discharge out of the hospital in postoperative days (day of surgery = day 0)
11. Pneumonia defined as empirical antibiotic therapy for suspicion of pneumonia during hospital stay, in number of patients.
12. Serum bupivacaine levels have never been recorded after SAPB. In the first 36 study patients, arterial blood samples will be taken at 30minutes as well as at 1, 2, 4 and 8 hours after block placement for dosage of total and free plasma bupivacaine levels.
13. Quality of recovery will be assessed at POD 2 and POD 7 with Quality of Life questionnaires: EQ5D and short form health survey (SF-36).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Jessa Ziekenhuis

Sponsor organisation

Jessa Ziekenhuis

Address

Stadsomvaart 11

City

Hasselt

Postcode

3500

Country

Belgium

Scientific contact point

Organisation

Jessa Ziekenhuis

Contact name

Bjorn Stessel

Public contact point

Organisation

Jessa Ziekenhuis

Contact name

Bjorn Stessel

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

2 submissions — initial application plus substantial / non-substantial modifications