Heart Valve Disease, Postoperative Pain
Conditions
Keywords
Cardiac Surgery, Postoperative Pain
Brief summary
This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the serratus posterior superior intercostal plane (SPSIP) block on postoperative pain and opioid consumption in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy.
Detailed description
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Postoperative pain following thoracic cardiac surgery may impair respiratory function and delay recovery, making effective analgesia essential. Participants will be randomly assigned to receive an ultrasound-guided SPSIP block with either bupivacaine or normal saline under identical conditions. All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Blinding will be ensured for patients and outcome assessors. The study aims to determine whether SPSIP block with local anesthetic reduces postoperative opioid consumption and improves pain control compared to placebo.
Interventions
PROCEDURESerratus Posterior Superior Intercostal Plane Block With Bupivacaine
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia.
PROCEDURESerratus Posterior Superior Intercostal Plane Block With Saline
Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Study solutions (bupivacaine or normal saline) will be prepared by an independent anesthesiologist according to the randomization sequence. The syringes will be identical in appearance, volume, and labeling. The anesthesiologist performing the block will not be aware of the syringe content.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to receive either SPSIP block with bupivacaine or SPSIP block with saline. Both groups will undergo identical procedures under standardized conditions, and outcomes will be compared between parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18-75 years * ASA physical status I-III * Scheduled for elective minimally invasive cardiac valve surgery via mini-thoracotomy * Able to understand and use the Numeric Rating Scale (NRS) * Provided written informed consent
Exclusion criteria
* Age \>75 years * Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine) * Coagulopathy or ongoing anticoagulant therapy that cannot be discontinued * Infection at the planned block site * Chronic opioid use or chronic pain conditions * Severe pulmonary disease affecting respiratory assessment * Neurological or psychiatric disorders interfering with pain assessment * Emergency surgery * Pregnancy or breastfeeding * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour cumulative opioid consumption | 24 hours after surgery | Total opioid consumption within the first 24 hours after surgery, expressed as intravenous morphine milligram equivalents (IV-MME). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity at rest (NRS) | 4, 6, 12, and 24 hours after surgery | Pain intensity at rest measured using the Numeric Rating Scale (0-10). |
| Postoperative pain during movement (NRS) | 4, 6, 12, and 24 hours after surgery | Pain intensity during coughing or deep breathing measured using the Numeric Rating Scale (0-10). |
| Time to first rescue analgesia | Within 24 hours after surgery | Time from the end of surgery to the first administration of rescue analgesia. |
| Time to extubation | From the end of surgery until extubation, assessed up to 24 hours | Time from the end of surgery to extubation. |
| Length of intensive care unit stay | Through study completion, an average of 48 hours | Duration of stay in the intensive care unit. |
| Length of hospital stay | From date of admission until discharge, up to 30 days | Total duration of hospitalization. |
| Inspiratory Spirometry Test | 4, 6, 12, and 24 hours after surgery | Inspiratory spirometry performance will be assessed using an incentive spirometer. Inspiratory capacity will be estimated based on the number of rising balls: 1 ball = 600 mL, 2 balls = 900 mL, and 3 balls = 1200 mL. The score ranges from a minimum of 1 ball to a maximum of 3 balls, with higher scores indicating better inspiratory function. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFatma Acil, M.D.
PRINCIPAL_INVESTIGATORFatma Acil, M.D.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Outcome results
None listed