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

Fudan University logo

Fudan University

Status

Completed

Conditions

Thoracotomy
Pain, Postoperative
Anesthesia

Treatments

Procedure: Serratus anterior plane block
Drug: Intravenous patient-controlled-analgesia morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT03839160
truncal block SAPB

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups, including a placebo group

SAPB group. Group S
Active Comparator group
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.
Treatment:
Drug: Intravenous patient-controlled-analgesia morphine
Procedure: Serratus anterior plane block
Control group. Group C
Placebo Comparator group
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.
Treatment:
Drug: Intravenous patient-controlled-analgesia morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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