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Erector Spinae Block for Thoracoscopic Surgery

S

St. Antonius Hospital

Status

Completed

Conditions

Postoperative Pain
Thoracic Neoplasms

Treatments

Procedure: Erector Spinae Plane Block (for postoperative pain relief)

Study type

Interventional

Funder types

Other

Identifiers

NCT04751552
L20.047

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Levobupivacaine group
Active Comparator group
Description:
Patients receive an ESPB with the local anaesthetic levobupivacaine
Treatment:
Procedure: Erector Spinae Plane Block (for postoperative pain relief)
Placebo group
Placebo Comparator group
Description:
Patients receive an ESPB with 0,9% saline
Treatment:
Procedure: Erector Spinae Plane Block (for postoperative pain relief)

Trial contacts and locations

1

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Central trial contact

Leon Timmerman, M.D., PhD; Pauline Nijk, M.D.

Data sourced from clinicaltrials.gov

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