Erector Spinae Block for Thoracoscopic Surgery

NCT ID: NCT04751552

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2023-09-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain Thoracic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled double blind trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blind

Study Groups

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Levobupivacaine group

Patients receive an ESPB with the local anaesthetic levobupivacaine

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane Block (for postoperative pain relief)

Intervention Type 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.

Placebo group

Patients receive an ESPB with 0,9% saline

Group Type PLACEBO_COMPARATOR

Erector Spinae Plane Block (for postoperative pain relief)

Intervention Type 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.

Interventions

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Erector Spinae Plane Block (for postoperative pain relief)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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Leon Timmerman

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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L20.047

Identifier Type: -

Identifier Source: org_study_id

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