MedTrace Logo

Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy

NCT06369870 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2024-09-19

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery.

Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups.

Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery.

Conditions

  • Analgesic Effect

Interventions

DRUG

Levobupivacaine Hydrochloride 0.25 % Injectable Solution

After wound closure, the IPP-PSP block is performed at the level of the 4th rib. At the pre-axillary line, the pectoralis major, the pectoralis minor and the serratus anterior muscle are identified. At first, the needle is positioned in the fascial plane between the pectoralis minor and the serratus anterior muscle. The needle position is confirmed by hydro-dissection of this plane with 2 mL of normal saline 0.9%.The 20 ml syringe with trial drug solution is injected in this pectoserratus plane (PSP). The needle tip is repositioned in the interpectoral plane between both the pectoralis major and minor muscle. The 10 ml syringe with trial drug solution is administered in this interpectoral plane (IPP).

DRUG

Sodium chloride 0.9%

Unilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. The IPP-PSP block procedure will be carried out as described in the intervention description of the IPP-PSP block.

Sponsors & Collaborators

  • Algemeen Ziekenhuis Maria Middelares

    lead OTHER

Principal Investigators

  • Bart Vaes, MD · Algemeen Ziekenhuis Maria Middelares

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-11-30
Completion
2027-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06369870 on ClinicalTrials.gov