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Clinical Trials/NCT03839160
NCT03839160
Completed
Not Applicable

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

Shanghai Zhongshan Hospital1 site in 1 country90 target enrollmentDecember 1, 2019

Overview

Phase
Not Applicable
Intervention
Serratus anterior plane block
Conditions
Pain, Postoperative
Sponsor
Shanghai Zhongshan Hospital
Enrollment
90
Locations
1
Primary Endpoint
visual analog scale
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
May 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Arms & Interventions

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.

Intervention: Serratus anterior plane block

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.

Intervention: Intravenous patient-controlled-analgesia morphine

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.

Intervention: Intravenous patient-controlled-analgesia morphine

Outcomes

Primary Outcomes

visual analog scale

Time Frame: Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

Adult Pain Visual Analog Scale

Secondary Outcomes

  • Catheter-related profile(at Day 1, Day2 and Day 3 post-operation)
  • Hemodynamic profile - Heart rate(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)
  • Hemodynamic profile - blood pressure(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)
  • Hemodynamic profile - SpO2(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)
  • Opioids-related side effects - nausea(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)
  • Morphine consumption(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)

Study Sites (1)

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