Fascial Plane Blocks and Quality of Recovery in Cardiac Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorOrdu University
About this trial
In this randomized trial, the investigators will test the hypothesis that combining regional analgesia techniques-which have the potential to improve the quality of postoperative recovery following median sternotomy-with PIFB will accelerate recovery. Additionally, it is anticipated that RIFB, an alternative fascial plane block, will demonstrate non-inferior (at least as effective as) performance compared to RSB, thereby providing flexibility and ease of application in clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have provided written informed consent
Open-heart surgery performed under elective conditions via median sternotomy with cardiopulmonary bypass (on-pump)
American Society of Anesthesiologists (ASA) physical status class II or III
Aged 18-70 years
Disqualifiers
Off-pump surgical procedure
Emergency or repeat cardiac surgery
Known allergy to induction agents or local anesthetics
Body mass index (BMI) >35 kg/m²
Trial population
Patients aged 18-70 years, with ASA physical status II-III, who are scheduled to undergo elective open-heart surgery via median sternotomy with cardiopulmonary bypass at a tertiary care city hospital.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Ultrasound-Guided Pectointercostal Fascial Plane Block
Procedure/SurgeryFollowing anesthesia induction, bilateral pectointercostal fascial plane block (PIFB) will be performed under steril conditions using a high-frequency linear US probe positioned parallel to the parasternal region. The second and fourth ribs will be identified in the parasternal region under US guidance. A 100-mm echogenic peripheral nerve block needle will be advanced craniocaudally toward the fourth rib using an in-plane technique to reach the fascial plane between the pectoralis major and intercostal muscles. After confirming the target plane via hydrodissection, 20 mL of 0.25% bupivacaine will be injected into the fascial plane on each side (total 40 mL). The success of the block will be confirmed by sliding the US probe craniocaudally to directly visualize the local anesthetic spread between the pectoralis major fascia and the intercostal muscles (extending from the first to the sixth rib).
Ultrasound-Guided Rectus Sheath Block
Procedure/SurgeryBilateral rectus sheath block (RSB) will be performed at the end of surgery. A high-frequency linear US probe will be positioned in the epigastric region, 2-3 cm below the xiphoid process and immediately below the chest tubes, intersecting the linea alba perpendicularly. After identifying the anatomical structures (anterior rectus abdominis sheath, muscle, posterior sheath, and peritoneum) with the US probe, a 100-mm echogenic peripheral block needle will be advanced into the plane between the rectus abdominis muscle and the posterior sheath using an in-plane technique. After confirming the needle tip location via hydrodissection, a total of 20 mL of 0.25% bupivacaine (10 mL per side) will be injected into the fascial plane. Block success will be confirmed by direct visualization of the "double V"-shaped echogenic pattern formed by the spread of the local anesthetic between the fascial planes.
Ultrasound-Guided Recto-Intercostal Fascial Plane Block
Procedure/SurgeryBilateral recto-intercostal fascial plane block (RIFB) will be performed at the end of surgery. A high-frequency linear US probe will be positioned in the sagittal plane, 3-4 cm lateral and 3-4 cm caudal to the xiphoid process. After identifying the sixth and seventh costal cartilages and the rectus abdominis muscle, a 100-mm echogenic peripheral block needle will be advanced caudo-cranially using an in-plane technique to reach the plane between the rectus abdominis muscle and the costal cartilage. After confirming the needle tip location via hydrodissection, a total of 20 mL of 0.25% bupivacaine (10 mL per side) will be injected into the fascial plane. Block success will be confirmed by direct visualization of the local anesthetic spread in a cranio-caudal direction.
Treatment groups
123 Participants
are divided into 3 treatment groupsGroup A: Group P1 intervention
Group B: Group PRS2 interventions
Group C: Group PRI2 interventions
Trial outcomes
Primary outcomes
1
Turkish version of the Quality of Recovery-15 scale (QoR-15T)
The QoR-15T scale consists of a total of 15 items, each scored on a 0-10 scale (a 11-point Likert-type scale). The total score ranges from 0 (very poor recovery) to 150 (excellent recovery). While total scores of 118 and above are generally accepted in the literature as an indicator of 'good recovery,' scores can also be classified as 136-150 (excellent), 122-135 (good), 90-121 (moderate), and 0-89 (poor). The scale covers five domains: physical comfort (items 1-4 and 13), emotional state (items 9, 10, 14, and 15), psychological support (items 6 and 7), physical independence (items 5 and 8), and pain (items 11 and 12).
Time frame
In the postoperative period, the time of extubation will be considered "postoperative hour 0". The primary endpoint is the quality of early recovery, assessed at 24 hours postoperatively.Secondary outcomes
1
Turkish version of the Quality of Recovery-15 scale (QoR-15T)
The QoR-15T scale consists of a total of 15 items, each scored on a 0-10 scale (a 11-point Likert-type scale). The total score ranges from 0 (very poor recovery) to 150 (excellent recovery). While total scores of 118 and above are generally accepted in the literature as an indicator of 'good recovery,' scores can also be classified as 136-150 (excellent), 122-135 (good), 90-121 (moderate), and 0-89 (poor). The scale covers five domains: physical comfort (items 1-4 and 13), emotional state (items 9, 10, 14, and 15), psychological support (items 6 and 7), physical independence (items 5 and 8), and pain (items 11 and 12).
Time frame
In the postoperative period, the time of extubation will be considered "postoperative hour 0". QoR-15T scores will be reassessed at 48 hours postoperatively and prior to discharge.2
The Numerical Rating Scale (NRS)
NRS contains 11 digits that should be assigned according to the perceived pain intensity (0: no pain, 10: the most severe pain imaginable).
Time frame
All cases will be assessed using the NRS at 0, 3, 6, 12, 24, 36, and 48 hours after extubation.3
Total Tramadol Consumption
A standard analgesia protocol will be administered to all patients for postoperative pain management. No additional opioids will be given between the end of surgery and extubation. Total tramadol consumption will be recorded during the first 48 hours post-extubation to evaluate opioid use. The postoperative observation phase of the study has been defined to encompass the first 48 hours following extubation.During the observation phase, patients with a Numerical Rating Scale (NRS) score of ≥4 will receive IV tramadol (1 mg/kg, max 400 mg/day) as rescue analgesia.
Time frame
Total tramadol consumption will be recorded during the first 48 hours post-extubation to evaluate opioid use.4
Opioid-Related Adverse Effects During the Postoperative Observation Phase
Nausea, Vomiting, Pruritus, Constipation, Urinary Retention, and Arrhythmia
Time frame
Until hospital discharge (approximately 5-7 days)Sponsors and contacts
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Source ClinicalTrials.gov