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NCT Number: NCT03839160

The Efficacy of Serratus Anterior Plane Block (ESAPB) 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.

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Key information

Conditions

Pain, Postoperative Anesthesia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Thoracotomy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Serratus Anterior Plane Block

Procedure

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

Intravenous patient-controlled-analgesia morphine

Drug

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

Primary outcomes

  1. visual analog scale

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

    Adult Pain Visual Analog Scale

Secondary outcomes

  1. Hemodynamic profile - Heart rate

    Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

    Heart rate

  2. Hemodynamic profile - blood pressure

    Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

    blood pressure

  3. Hemodynamic profile - SpO2

    Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

    SpO2

  4. Opioids-related side effects - nausea

    Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

    nausea

  5. Catheter-related profile

    Time frame: at Day 1, Day2 and Day 3 post-operation

    The position of the catheter tip and the level of blockade

  6. Morphine consumption

    Time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation

    Morphine consumption

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 15, 2019
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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