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NCT Number: NCT04751552

Erector Spinae Block for Thoracoscopic Surgery

This randomized clinical trial compares the effects of the erector spinae plane block with levobupivacaine and 0,9% saline on postoperative pain intensity, and opioid consumptions following thoracoscopic pulmonary surgery.

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Key information

Conditions

Postoperative Pain Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

About this study

Sixty patients planned for thoracoscopic pulmonary surgery are randomly assigned to an erector spinae plane block (ESPB) with levobupivacaine (intervention group) or 0,9% saline (control group). ESPB is performed under general anaesthesia before surgery.

Postoperative pain medication incudes acetominophen, NSAIDs en parenteral morphine (patient controlled analgesia).

Following surgery pain intensity (numeric rating scale) is registered at the recovery ward one hour after surgery. Furthermore, pain intensity is registered 2,4,8, 12 hours after the operation. On the first postoperative day, pain intensity is registered at 8.00 o'cock AM and 8.00 o'clock PM. Opioid consumption is registered as a second parameter of postoperative pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for thoracoscopic pulmonary sleeve resection or lobectomy
  • Age 18 years or older
  • American Society of Anesthesiologists (ASA) health status class I-III
  • Informed consent

Exclusion criteria

  • Contraindication for regional analgesia (e.g. coagulopathy, infection at injection site)
  • Contraindication for NSAIDs
  • Chronic opioid use
  • Pregnancy

Treatment and study plan

Erector Spinae Plane Block (for postoperative pain relief)

Procedure

A ultrasound guided single bolus injection of 20 ml of levobupivacaine or placebo between the erector spinae muscle and process transversus of vertebra T5.

Primary outcomes

  1. Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery.

    Time frame: 2 hours postoperatively

    Pain level 2 hours after surgery

  2. Pain intensity (NRS) 4 hours after surgery.

    Time frame: 4 hours postoperatively

    Pain level 4 hours after surgery

  3. Pain intensity (NRS) 8 hours after surgery.

    Time frame: 8 hours postoperatively

    Pain level 8 hours after surgery

  4. Pain intensity (NRS) 12 hours after surgery.

    Time frame: 12 hours postoperatively

    Pain level twelve hours after surgery

Secondary outcomes

  1. Pain intensity (NRS) at 8.00 o'clock on the first postoperative day

    Time frame: At 8 o'clock AM on the first postoperative day

    Pain level at 8.00 o'clock on the first postoperative day

  2. Pain intensity (NRS) at 20.00 o'clock on the first postoperative day

    Time frame: At 8 o'clock PM on the first postoperative day

    Pain level at 20.00 o'clock on the first postoperative day

  3. Opioid consumption

    Time frame: First 48 hours after surgery, recorded following disconnection of the PCA device at 8 o'clock AM on the second postoperative day.

    Parenteral morphine use (mg) as recorded by the Patient-Controlled Analgesia (PCA) device

  4. length of stay in recovery ward (minutes)

    Time frame: First 48 hours after surgery

    length of stay in recovery ward (minutes) after surgery

  5. Patient satisfaction of pain therapy

    Time frame: Measurement in the morning of the second postoperative day

    Patient satisfaction of pain therapy (numeric rating scale 0-10(0=severely dissatisfied up to 10= maximally satisfied)

  6. Presence of side effects

    Time frame: First 48 hours

    Daily scoring of side effects (nausea, drowsiness, pruritus, other (yes/no))

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

Effect of Erector Spinae Plane Block on Postoperative Pain Intensity in Patients Undergoing Thoracoscopic Surgery: a Randomized Clinical Trial.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2021
Registry last updated
Sep 13, 2023

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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