Erector Spinae Block for Thoracoscopic Surgery

NCT04751552 | Completed

• 1 other identifier: L20.047
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Thoracic Neoplasms

Keywords

Thoracoscopy; Pain; Regional anaesthesia

Outcome Measures

Primary Outcomes (4)

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

  Pain level 2 hours after surgery

  2 hours postoperatively

• Pain intensity (NRS) 4 hours after surgery.

  Pain level 4 hours after surgery

  4 hours postoperatively

• Pain intensity (NRS) 8 hours after surgery.

  Pain level 8 hours after surgery

  8 hours postoperatively

• Pain intensity (NRS) 12 hours after surgery.

  Pain level twelve hours after surgery

  12 hours postoperatively

Secondary Outcomes (6)

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

  At 8 o'clock AM on the first postoperative day

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

  At 8 o'clock PM on the first postoperative day

• Opioid consumption

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

• length of stay in recovery ward (minutes)

  First 48 hours after surgery

• Patient satisfaction of pain therapy

  Measurement in the morning of the second postoperative day

Study Arms (2)

Levobupivacaine group

ACTIVE COMPARATOR

Patients receive an ESPB with the local anaesthetic levobupivacaine

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

Placebo group

PLACEBO COMPARATOR

Patients receive an ESPB with 0,9% saline

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

Interventions

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.

Levobupivacaine group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

MeSH Terms

Conditions

Pain, Postoperative; Thoracic Neoplasms; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Randomized controlled double blind trial

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: February 12, 2021
• Study Start: October 21, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 2, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following the report of the study

Locations

NL (1)