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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839160
• Other study ID #: truncal block SAPB
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative
• Thoracotomy

Intervention

Procedure:
• Serratus anterior plane block
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.

Drug:
• Intravenous patient-controlled-analgesia morphine
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.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale	Adult Pain Visual Analog Scale	Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Secondary	Hemodynamic profile - Heart rate	Heart rate	At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Secondary	Hemodynamic profile - blood pressure	blood pressure	At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Secondary	Hemodynamic profile - SpO2	SpO2	At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Secondary	Opioids-related side effects - nausea	nausea	At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Secondary	Catheter-related profile	The position of the catheter tip and the level of blockade	at Day 1, Day2 and Day 3 post-operation
Secondary	Morphine consumption	Morphine consumption	At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation