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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anesthesia; Thoracotomy
• Intervention / Treatment: Procedure: Serratus anterior plane block; Drug: Intravenous patient-controlled-analgesia morphine

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: SAPB group. Group S; 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; 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.; Other Names: Serratus plane block; 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.; Other Names: PCIA
PLACEBO_COMPARATOR: Control group. Group C; 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; 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.; Other Names: PCIA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Jing Cang, MD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: truncal block SAPB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No