Serratus Planus Block After Minimally Invasive Cardiac Surgery

NCT06746272 | Active Not Recruiting Phase 4

• 2 other identifiers: 1.52020-005220-10
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients receiving MICS (minimally invasive cardiac surgery) suffer from significant postsurgical pain. While systemic analgesic therapy has been proven to be insufficient in a great number of patients, significant unwanted side effects might occur. Therefore, the investigation of peripheral nerve blocks such as SAPB with potential for high benefit and low risk for adverse effects as new treatment options for thoracotomy-pain is relevant. Previous randomized double-blind investigations of this novel technique are lacking. At this moment our department's current standard of care is that, SAPB is performed in patients after MICS in our department if the treating anesthetist is experienced in the procedure and the patient receives i.v. analgesia only without nerve block is he or she is not. If we are able to show a benefit for patients in the SAPB arm, the nerve block may constitute a new standard of care for all MICS patients no only in our department but also after MICS in general. Patients ≥18 years of age, being treated in the cardiothoracic ICU after elective cardiac surgery performed via lateral minithoracotomy (mitral valve, tricuspid valve, atrial septal defect closure) will be included after signed informed consent before surgery. Allocation concealment is guaranteed by opening of the concealed envelope and performance of the ultrasound guided SAPB or ultrasound only by medical personnel not involved in any of the study procedures. Randomization will be carried out by a web-based software ('randomizer,). The intervention will be performed after ICU arrival but under sedation and analgesia before extubation to minimize patient discomfort and to ensure double blinding. Efficacy will be evaluated using Pain Scoring by visual analogue scale (VAS), opioid requirements, postoperative complications, need for rescue analgesia, lung function tests and markers of myocardial stress and inflammatory parameters in the early postoperative period according to our current protocol in the ICU.

Conditions

Pain, Postoperative

Keywords

analgesia; Serratus Anterior Planus Block; SAPB; pain; minimally invasive; cardiac surgery; MICS

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score: VAS 0-10

  average pain scores (VAS 0-10) reported according to our department's standards immediately after extubation, and if feasible 2, 4, 6,8,10,12 hours after SAPB (or standard i.v. therapy respectively)

  12 hours after successful respiratory weaning

Secondary Outcomes (6)

• postoperative morphine equivalents

  0-12 hours, 12-24 hours, 24-48hours after successful respiratory weaning

• VAS at 2, 4, 6, 8, 10, 12, 16, 24, 48 hours

  2-48 hours after application of the serratus block (SAPB)

• complications from the block, surgery or from postoperative pain

  0-48 hours after conclusion of respiratory weaning

• pulmonary function

  0-48 hours after conclusion of respiratory weaning

• inflammation and myocardial stress parameters

  immediately postoperatively, on postoperative day 1 and on postoperative day 2 after MICS

Other Outcomes (1)

• LOS in the ICU, LOS in hospital, hospital and 30 day mortality

  up tp 30 days after MICS

Study Arms (2)

SAPB group

ACTIVE COMPARATOR

Ultrasound guided Serratus anterior block will be performed according to the analgetic standard in our department.

Procedure: Serratus Anterior Plane Block

Standard i.v. analgesia group

NO INTERVENTION

A sterile plaster will be placed on an appropriate site to blind ICU and PACU personnel of the intervention. Patients will receive i.v. analgesia according to the analgesic standard of care in our department.

Interventions

Serratus Anterior Plane Block PROCEDURE

Ultrasound guided Serratus anterior block will be performed according to the analgetic standard in our department using an ultrasound guided transducer to inject 2mg/kg of 0.5% ropivacaine with an adjuvant. A sterile plaster will be placed on the puncture site after performing the block. Patients will receive i.v. analgesia according to the analgesic standard of care in our department.

SAPB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or more
• patients undergoing cardiac surgery through a thoracotomy incision
• patients having surgery performed by a Cardiac Surgeon at the Medical University of Vienna
• patients being treated in the 16 bed primary cardiothoracic ICU 13B-HTG at the Medical University of Vienna
• patients being treated in the 4 bed PACU of the cardiothoracic and vascular anesthesia department at the Medical University of Vienna
• signed patient consent prior to surgery

You may not qualify if:

• patients requiring full sternotomy or emergency surgery
• Allergy to amid-type local anesthetics
• patients less that 18 years of age at the time of surgery
• patients intubated \>48h prior to surgery
• Infection at the site of the Serratus Anterior Plane Block
• Known bleeding diathesis with increased risk of hematoma at the block site
• Known opioid abuse
• Allergy to (metamizole AND acetaminophen) OR (hydromorphone AND Piritramide)
• Active pulmonary infection at the time of surgery
• Patient refusal prior to surgery
• Inability to communicate
• BMI ≥40
• Patients with known dementia or/and a legal guardian for medical issues
• Patients unable to understand the study measures and are not able to complete pain assessment forms.
• Known pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1080, Austria

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Bernhard Zapletal, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia and Critical care consultant

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)