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

Primary Purpose

Pain, Postoperative, Anesthesia, Thoracotomy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Serratus anterior plane block
Intravenous patient-controlled-analgesia morphine
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SAPB group. Group S

Control group. Group C

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

visual analog scale
Adult Pain Visual Analog Scale

Secondary Outcome Measures

Hemodynamic profile - Heart rate
Heart rate
Hemodynamic profile - blood pressure
blood pressure
Hemodynamic profile - SpO2
SpO2
Opioids-related side effects - nausea
nausea
Catheter-related profile
The position of the catheter tip and the level of blockade
Morphine consumption
Morphine consumption

Full Information

First Posted
November 23, 2017
Last Updated
May 10, 2021
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03839160
Brief Title
The Efficacy of Serratus Anterior Plane Block (ESAPB) for Thoracotomy: a Prospective Study
Official Title
The Efficacy of Serratus Anterior Plane Block in Analgesia for Thoracotomy: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anesthesia, Thoracotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAPB group. Group S
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group. Group C
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane block
Other Intervention Name(s)
Serratus plane block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous patient-controlled-analgesia morphine
Other Intervention Name(s)
PCIA
Intervention Description
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 Measure Information:
Title
visual analog scale
Description
Adult Pain Visual Analog Scale
Time Frame
Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Secondary Outcome Measure Information:
Title
Hemodynamic profile - Heart rate
Description
Heart rate
Time Frame
At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Title
Hemodynamic profile - blood pressure
Description
blood pressure
Time Frame
At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Title
Hemodynamic profile - SpO2
Description
SpO2
Time Frame
At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Title
Opioids-related side effects - nausea
Description
nausea
Time Frame
At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Title
Catheter-related profile
Description
The position of the catheter tip and the level of blockade
Time Frame
at Day 1, Day2 and Day 3 post-operation
Title
Morphine consumption
Description
Morphine consumption
Time Frame
At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Cang, MD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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

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