Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery

Coronary Artery Disease Clinical Trial

Official title:

A Comparison of the Analgesic Effects of Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery: a Prospective, Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908449
• Other study ID #: PRO00040365
• Status: Recruiting
• Phase: Phase 1
• Start date: June 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Medical College of Wisconsin
• Contact: Anne Castro, MD
• Phone: 414-805-2715
• Email: anncastro[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from elective cardiac surgery involving primary median sternotomy and mediastinal chest tubes in comparison to pectointercostal fascial plane blocks alone.

Description:

This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 50-60 subjects, with 25-30 in each group.

Primary Outcomes:

Pain scores on a 0-10 visual analog scale (VAS) at rest and with deep breathing at 1, 3, 6, 12, 18, and 24 hours post-extubation between subjects receiving PIFB + RSB versus subjects receiving only PIFB.

Total cumulative opioid consumption at 24 and 48 hours post-operatively.

Secondary Outcomes:

• Intraoperative total opioid consumption

• Change from baseline on incentive spirometry at 1, 3, 12, and 24 hours post-extubation

• Time from ICU arrival to liberation from mechanical ventilation

• QoR-15 (Quality of Recovery) score23 24 hours after extubation

• Hospital and ICU length of stay

Preoperative Management :

Subjects will be randomized on the morning of surgery to receive bilateral PIFB and bilateral RSB with local anesthetic versus bilateral PIFB with local anesthetic and bilateral RSB with saline (placebo).

Intraoperative Management All subjects will receive the standard of care anesthetic regimen for their cardiac surgery.

Postoperative Management Each PIFB will be performed with 15 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine, and bilateral RSB will be performed with an additional 20 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine (10mL on each side).

Postoperative Evaluation:

Evaluation of acute postoperative pain intensity using a 0-10 visual analog scale (VAS) will be undertaken at the following time points, both at rest and with deep breathing:

• 1, 3, 6, 12, 18, and 24 hours post-extubation Incentive spirometry will be assessed at 1, 3, 12, and 24 hours post-extubation, with three measures taken at each time point in order to compare postoperative performance with baseline spirometry.

Review of the medical chart will be made post-operatively to gather other data, including total intraoperative oral morphine equivalent consumption, cumulative opioid consumption at 24 and 48 hours, time from ICU arrival to tracheal extubation, hospital and ICU length of stay, and QoR-15 (Quality of Recovery) score administered 24 hours after extubation (with margin of error of 18-30 hours to avoid waking patients in the middle of the night) . Occurrences of any adverse events reported by the subject or medical team will also be collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subjects scheduled for cardiac surgery involving primary median sternotomy and mediastinal chest tubes.

• Age 18-85 years of age

• BMI 18-50 kg/m2

• Weight > 60 kg

Exclusion Criteria:

• Left ventricular ejection fraction (LVEF) < 30%

• Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)

• Inability to understand or speak English

• Allergy to bupivacaine or other amide local anesthetic

• Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site)

• Chronic opioid consumption (daily oral morphine equivalent of >20 mg) in the past three months

• Severe pulmonary or hepatic disease

• Neurological deficit or disorder

• Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years

• Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder

Related Conditions & MeSH terms

• Coronary Artery Disease
• Pain, Postoperative
• Postoperative Pain
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Rectus sheath block with bupivacaine
Rectus sheath block with local anesthetic versus sham block with saline

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	1 hour post-extubation
Primary	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	3 hours post-extubation
Primary	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	6 hours post-extubation
Primary	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	12 hours post-extubation
Primary	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	18 hours post-extubation
Primary	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	Pain scores on a 0-10 visual analog scale at rest and with deep breathing	24 hours post-extubation
Primary	Total cumulative opioid consumption	Total cumulative opioid consumption at 24 hours	24 hours post-operatively
Primary	Total cumulative opioid consumption	Total cumulative opioid consumption at 48 hours	48 hours post-operatively
Secondary	Intraoperative total opioid consumption	Intraoperative total opioid consumption	From anesthesia start to anesthesia stop
Secondary	Time from ICU arrival to liberation from mechanical ventilation	Time from ICU arrival to liberation from mechanical ventilation	ICU arrival until extubation
Secondary	Vital capacity change from baseline on incentive spirometry	Vital capacity change from baseline on incentive spirometry	1 hour post-extubation
Secondary	Vital capacity change from baseline on incentive spirometry	Vital capacity change from baseline on incentive spirometry	3 hours post-extubation
Secondary	Vital capacity change from baseline on incentive spirometry	Vital capacity change from baseline on incentive spirometry	12 hours post-extubation
Secondary	Vital capacity change from baseline on incentive spirometry	Vital capacity change from baseline on incentive spirometry	24 hours post-extubation
Secondary	QoR-15 (Quality of Recovery) score	QoR-15 (Quality of Recovery) score	24 hours after extubation
Secondary	ICU Length of Stay	ICU Length of Stay	Time from anesthesia stop to transfer out of ICU, typically 24 hours
Secondary	Hospital Length of Stay	Hospital Length of Stay	Time from anesthesia stop to hospital discharge, typically one week