Postoperative Pain ControlNCT07877532
Serratus Anterior Plane Block for Recovery After Minimally Invasive CABG
A study testing Ultrasound-guided Serratus Anterior Plane Block with Ropivacaine and Ultrasound-guided Serratus Anterior Plane Block with Normal Saline in people with Postoperative Pain Control and Coronary Artery Disease, run by Chinese PLA General Hospital.
Trial summary
Coronary artery bypass surgery is an important treatment method for severe coronary heart disease. Among them, minimally invasive bypass surgery, although having less trauma, requires a small incision on the left chest. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain Control, Coronary Artery Disease
- What is being tested?
- Ultrasound-guided Serratus Anterior Plane Block with Ropivacaine and Ultrasound-guided Serratus Anterior Plane Block with Normal Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2026to 30 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years;
- Scheduled to undergo elective minimally invasive coronary artery bypass grafting (MIDCABG);
- Able to understand and complete the 15-item Quality of Recovery (QoR-15) questionnaire;
- Provision of written informed consent.
Who cannot join
- ASA physical status class IV or higher;
- Known allergy to local anesthetics (Ropivacaine);
- Coagulation disorders or infection at the puncture site;
- Cognitive impairment or inability to cooperate with pain assessment and questionnaire completion;
- Undergoing emergency surgery;
- Severe hepatic or renal insufficiency.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Ultrasound-Guided Serratus Anterior Plane Block on Postoperative Recovery Quality in Patients Undergoing Minimally Invasive Coronary Artery Bypass Grafting: A Single-Center, Randomized, Double-Blind Controlled Trial
Coronary artery bypass surgery is an important treatment method for severe coronary heart disease. Among them, minimally invasive bypass surgery, although having less trauma, requires a small incision on the left chest. During the operation, the ribs need to be opened and the muscles of the chest wall pulled, which is prone to causing intercostal nerve damage. Therefore, many patients still experience severe incision pain and chest wall pain after the surgery.
This study adopted the "Serratus Anterior Plane Block", which is a regional anesthesia technique. The doctor will inject the anesthetic drug into the gap near the pectoralis major muscle (a muscle located on the side of the chest) under ultrasound guidance. This technique can effectively block the nerves that transmit pain signals, thereby providing good analgesic effects for the anterior lateral chest wall and helping patients alleviate postoperative pain.
Read the detailed description
Coronary artery bypass grafting (CABG) is an effective revascularization method for treating severe coronary heart disease. Traditional CABG uses a midline thoracotomy approach, providing sufficient exposure of the surgical field. However, sternotomy can cause severe postoperative pain, affecting patients' coughing, expectoration, and early activities, and increasing the risk of pulmonary complications and chronic pain. In recent years, with the deepening of the concept of minimally invasive surgery, minimally invasive direct coronary artery bypass grafting (MIDCABG) has been widely used in clinical practice due to its advantages of less trauma, less blood loss, and faster recovery. However, MIDCABG uses a small incision on the left chest for entry, and the surgery involves rib opening, pulling of chest wall muscles and intercostal nerve, and can still cause severe incision pain and chest wall pain after the operation. Its pain management is not easier than traditional thoracotomy surgery.
Opioid analgesia has always been used as the main method for postoperative pain management in cardiac surgery, but its related side effects (such as nausea, vomiting, respiratory depression, and urinary retention) affect the patient's recovery, so the postoperative accelerated recovery (ERAS) guidelines recommend incorporating regional block techniques into the multimodal analgesia plan for cardiac surgery. From a mechanism perspective, regional block can not only effectively control acute pain but also block pain transmission, reduce the dosage of opioids, thereby reducing opioid-induced hyperalgesia, and may prevent the occurrence of CPSP. However, thoracic paravertebral block and epidural anesthesia are operationally difficult and risky, especially in anticoagulated patients. In this context, the simpler and safer fascial plane block is considered a better choice. Among them, the serratus anterior plane block (SAPB) can effectively block the lateral branches of the intercostal nerves by injecting local anesthetic into the superficial or deep fascial space of the serratus anterior muscle, providing precise pain relief for the anterior lateral chest wall. The value of SAPB in thoracic surgery analgesia has been confirmed by multiple studies, but its clinical effect in MIDCABG is controversial. In conclusion, in the specific surgical scenario of MIDCABG, SAPB, as a key component of multimodal analgesia, its clinical efficacy and application strategies still require in-depth verification through well-designed randomized controlled studies. Based on the above background, this research intends to conduct a randomized controlled trial to systematically evaluate the impact of ultrasound-guided SAPB on the postoperative recovery quality of patients undergoing MIDCABG, with the aim of providing higher-level evidence-based medical evidence for optimizing the perioperative analgesic plan of MIDCABG.
- Being tested
- Ultrasound-guided Serratus Anterior Plane Block with Ropivacaine, Ultrasound-guided Serratus Anterior Plane Block with Normal Saline
- Keywords
- Serratus Anterior Plane Block, Postoperative Recovery Quality
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Serratus Anterior Plane Block with RopivacaineProcedure or surgery
After anesthesia induction and before surgical incision, patients receive a left-sided ultrasound-guided Serratus Anterior Plane Block (SAPB) in the operating room. A high-frequency linear ultrasound probe, a 22G/50mm regional block needle, and sterile coupling agent are used. The intervention consists of 30 mL of 0.5% Ropivacaine.
Ultrasound-guided Serratus Anterior Plane Block with Normal SalineProcedure or surgery
After anesthesia induction and before surgical incision, patients receive a left-sided ultrasound-guided Serratus Anterior Plane Block (SAPB) in the operating room. A high-frequency linear ultrasound probe, a 22G/50mm regional block needle, and sterile coupling agent are used. The intervention consists of 30 mL of 0.9% normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided SAPB with Ropivacaine | Experimental | Patients in this group receive general anesthesia combined with a left-sided ultrasound-guided Serratus Anterior Plane Block (SAPB) using 30 mL of 0.5% Ropivacaine. This group is designed to evaluate the analgesic efficacy of the intervention. Receives: Procedure: Ultrasound-guided Serratus Anterior Plane Block with Ropivacaine |
| Ultrasound-guided SAPB with Normal Saline | Placebo comparator | Patients in this group receive general anesthesia combined with a left-sided ultrasound-guided Serratus Anterior Plane Block (SAPB) using 30 mL of 0.9% normal saline as a placebo. This group serves as the control for comparison. Receives: Procedure: Ultrasound-guided Serratus Anterior Plane Block with Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 (QoR-15) score
The QoR-15 is a 15-item questionnaire assessing postoperative recovery quality across 5 dimensions (pain, physical comfort, physical independence, psychological support, and emotional state). The total score ranges from 0 to 150, with higher scores indicating better recovery quality. It has been validated in cardiac surgery populations.
Measured: Postoperative day 1, 2, and 3 (24, 48, and 72 hours after surgery)
Secondary outcomes (8)
Pain intensity using the Numerical Rating Scale (NRS)
Resting and movement-evoked pain intensity assessed using an 11-point NRS (0 = no pain, 10 = worst pain imaginable).
Measured: Postoperative day 1, 2, and 3 (24, 48, and 72 hours after surgery)
Rescue analgesic consumption
Total amount of rescue analgesics administered after surgery.
Measured: Postoperative day 1 to 3 (within 72 hours after surgery).
Incidence and characteristics of chronic postsurgical pain (CPSP)
Assessed using the Brief Pain Inventory (BPI) and Douleur Neuropathique 4 (DN-4) questionnaire. A structured telephone interview will screen for CPSP, followed by in-person or video consultation with a pain specialist if needed. CPSP diagnosis requires: (1) pain onset after surgery or significant exacerbation; (2) duration ≥ 3 months with impact on quality of life; (3) pain after a pain-free interval or evolution from acute postoperative pain; (4) localized to surgical area or related nerve distribution; (5) exclusion of other causes.
Measured: Preoperative baseline, 1 month, and 3 months after surgery.
Quality of life assessed by EuroQol 5-Dimension 5-Level questionnaire and the EuroQol Visual Analogue Scale.
Includes the EuroQol 5-Dimension 5-Level questionnaire descriptive system (mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each rated from level 1 to 5) and the EuroQol Visual Analogue Scale (EQ-VAS, 0-100, higher scores indicate better health status).
Measured: Preoperative baseline, 1 month, and 3 months after surgery.
Postoperative complications classified by the Clavien-Dindo classification
Includes postoperative adverse events (nausea/vomiting, sleep disturbance, mood disorders, delirium) and severe complications (myocardial infarction, heart failure, respiratory failure, stroke, gastrointestinal bleeding, sepsis, reoperation, and death).
Measured: Within 30 days after surgery.
Time to tracheal extubation within 72 hours after surgery
Interval from the end of surgery to tracheal extubation, assessed up to 72 hours after surgery.
Measured: From the end of surgery until tracheal extubation, assessed up to 72 hours after surgery.
Time to first active mobilization within 7 days after surgery
Interval from the end of surgery to first active mobilization with or without assistance, assessed up to 7 days after surgery.
Measured: From the end of surgery until first active mobilization, assessed up to 7 days after surgery.
Time to hospital discharge within 30 days after surgery
Number of days from the end of surgery to hospital discharge, assessed up to 30 days after surgery.
Measured: From the end of surgery until hospital discharge or 30 days after surgery, whichever came first, assessed up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start17 Sep 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Hao Li, MD, Study chair, Chinese PLA General Hospital, Beijing, Beijing 100853
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877532
- Sponsor's protocol ID
- PLA hospital
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No