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

Not Applicable

Completed

• Conditions: Thoracotomy; Pain, Postoperative; Anesthesia
• Interventions: Procedure: Serratus anterior plane block; Drug: Intravenous patient-controlled-analgesia morphine

• Registration Number: NCT03839160
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-15
• Study Start: 2019-12-01
• Primary Completion: 2020-12-31
• Status Verified: 2021-05
• Study Completion: 2021-05-01
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAPB group. Group S	Serratus anterior plane block	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.
Control group. Group C	Intravenous patient-controlled-analgesia morphine	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.
SAPB group. Group S	Intravenous patient-controlled-analgesia morphine	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.

Primary Outcome Measures

Name	Time	Method
visual analog scale	Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation	Adult Pain Visual Analog Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China