Clinical trial NCT03839160: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Anesthesia
Thoracotomy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: visual analog scale
timeFrame: Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Secondary outcomes:
measure: Hemodynamic profile - Heart rate
timeFrame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
measure: Hemodynamic profile - blood pressure
timeFrame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
measure: Hemodynamic profile - SpO2
timeFrame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
measure: Opioids-related side effects - nausea
timeFrame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
measure: Catheter-related profile
timeFrame: at Day 1, Day2 and Day 3 post-operation
measure: Morphine consumption
timeFrame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jing Cang, MD
role: STUDY_CHAIR
References: