The Efficacy of Serratus Anterior Plane Block (ESAPB) for Thoracotomy: a Prospective Study

Study Overview
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Brief Summary
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Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.

Detailed Description
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Thoracotomy is considered the most painful surgical procedure, even with thoracic epidural analgesia (TEA) as a golden standard for acute post-thoracotomy pain. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain, yet more evidence is needed to ascertain its efficacy. This is a prospective study carried out in a tertiary hospital. Patients scheduled for thoracotomy are randomized into two groups: Group M (intravenous patient-controlled-analgesia morphine) and Group S (intravenous patient-controlled analgesia morphine and SAPB). Morphine consumption, VAS pain score and Prince-Henry pain score are recorded for 72 hours respectively at PACU, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic pressure, diastolic pressure, mean arterial pressure and SpO2. Moreover, the profile of opioids-related side effects and length of hospital stay are documented. The primary objective of the study is to evaluate the efficacy of SAPB. The secondary objective is to compare the opioids-related side effects (including nausea, vomiting and pruritus), hemodynamic parameters and the length of hospital stay.

Official Title
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The Efficacy of Serratus Anterior Plane Block in Analgesia for Thoracotomy: a Prospective Study

Conditions
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Pain, Postoperative, Anesthesia, Thoracotomy

Intervention / Treatment
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* Procedure: Serratus anterior plane block
* Drug: Intravenous patient-controlled-analgesia morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II BMI 18-28kg/m2 Wedge incision and lobectomy Exclusion Criteria: Uncontrolled hypertension or chronic conditions History of opioid dependence Allergy to bupivacaine hydrochloride Severe bleeding during operation or post operation Inability to communicate with investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SAPB group. Group S<br>In this group, serratus anterior plane block (SAPB) was performed before extubation with injection of 30 ml of 0.25% bupivacaine hydrochloride followed by 0.1ml/kg/hr of 0.12% bupivacaine hydrochloride. In addition to SAPB, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time. | Procedure: Serratus anterior plane block<br>* Serratus anterior plane block was applied in Group S. It was performed at the end of the operation following the skin closure, while the patient lay on his side with his arm above the head. After proper site cleaning, the first and second ribs were identified with a linear probe in the midclavicular line. The USG probe was advanced caudally in the sagittal plane, and the fourth and fifth ribs were visualized. The USG probe was then directed posteriorly and the serratus, latissimus dorsi and intercostal muscles were visualized. Bupivacaine 0.25% 30 mL was administered to the lower plane of the serratus muscle through an inserted catheter under the guidance of USG through the in-line technique. Afterwards, 0.12% bupivacaine hydrochloride was maintained at the rate of 0.1ml/kg/hr.<br>* Other names: Serratus plane block;Drug: Intravenous patient-controlled-analgesia morphine<br>* Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.<br>* Other names: PCIA;|
| Placebo Comparator: Control group. Group C<br>In this group, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time. | Drug: Intravenous patient-controlled-analgesia morphine<br>* Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.<br>* Other names: PCIA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | Adult Pain Visual Analog Scale | Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic profile - Heart rate | Heart rate | At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation | 
| Hemodynamic profile - blood pressure | blood pressure | At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation | 
| Hemodynamic profile - SpO2 | SpO2 | At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation | 
| Opioids-related side effects - nausea | nausea | At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation | 
| Catheter-related profile | The position of the catheter tip and the level of blockade | at Day 1, Day2 and Day 3 post-operation | 
| Morphine consumption | Morphine consumption | At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation |