2025-522135-34-00
Not yet recruiting
Phase III and phase IV (Integrated)
The effect of a superficial parasternal intercostal plane block in cardiac surgical patients undergoing conventional median sternotomy: a multicentric, double-blind, prospective, randomized controlled superiority trial.
Overview
- Phase
- Phase III and phase IV (Integrated)
- Status
- Not yet recruiting
- Sponsor
- UZ Leuven
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- The primary outcome is the mean difference in QoR-15NL score between the verum bilateral SPIP block (intervention group) and the placebo bilateral SPIP block (control group) in patients undergoing cardiac surgery via conventional median sternotomy on the first postsurgical day, defined as 24 hours after surgical incision, assessed by the Dutch Quality of Recovery 15 items questionnaire.
Overview
Brief Summary
To investigate the efficacy of a bilateral superficial parasternal intercostal plane (SPIP) block in the postoperative recovery of patients undergoing cardiac surgery via conventional median sternotomy.
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Follow-up
- Masking
- Double (Investigator, Subject, Carer)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •At least 18 years of age at the time of signing the Informed Consent Form
- •Patients scheduled for cardiac surgery via conventional median sternotomy.
- •Patients with an European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 3 %.
- •Dutch speaking
Exclusion Criteria
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- •Patients with a bodyweight below 50 kg or exceeding 95 kg.
- •An adult who is incapable or unable to give consent (e.g. curatorship, guardianship, language barrier,…).
- •Patients requiring emergency surgery within 24 hours.
- •Patients with chronic pain (i.e., chronic opioid use or other analgesics)
- •Any disorder or medical condition, which in the principle investigator’s opinion, would jeopardise the patient’s safety or compliance with the trial. (allergies, concomitant drugs that interact with the IMP
- •If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive. Women of child-bearing potential (WOCBP) should only be included after a confirmed menstrual period and urinary pregnancy test. Participants are considered not of childbearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal, defined as no menses for 12 months without an alternative medical cause.
Outcomes
Primary Outcomes
The primary outcome is the mean difference in QoR-15NL score between the verum bilateral SPIP block (intervention group) and the placebo bilateral SPIP block (control group) in patients undergoing cardiac surgery via conventional median sternotomy on the first postsurgical day, defined as 24 hours after surgical incision, assessed by the Dutch Quality of Recovery 15 items questionnaire.
The primary outcome is the mean difference in QoR-15NL score between the verum bilateral SPIP block (intervention group) and the placebo bilateral SPIP block (control group) in patients undergoing cardiac surgery via conventional median sternotomy on the first postsurgical day, defined as 24 hours after surgical incision, assessed by the Dutch Quality of Recovery 15 items questionnaire.
Secondary Outcomes
- The cumulative opioid consumption in the first 72 hours after surgical incision
- Time to first rescue analgesia for breakthrough pain (e.g. oxycodone or piritramide) in the first 72 hours after surgical incision (in minutes).
- The AUC of the reported dynamic NRS scores at predefined timepoints (assessed at 3, 6, 12, 24, 48, 72 hours) during the first 72 hours after surgical incision.
- Number of patients with PONV in the first 24 hours after surgical incision
- Time spent in the ICU/PACU until fit for discharge (in hours).
- Time spent in the hospital between surgical incision and the first hospital discharge (in hours).
- Occurrence of respiratory complications, leading to non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy, orotracheal intubation for more than 24 hours or orotracheal re-intubation
- QoR-15NL score on the second (D2) after surgery
- EQ-5D-5L score 30 days after surgery
Investigators
Danny Hoogma
Scientific
UZ Leuven
Study Sites (2)
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