Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery

NCT03628040 | Unknown Phase 3

• 1 other identifier: 112452
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery that utilizes camera based scopes and specialized instruments through keyhole sized ports to remove lesions in the thoracic cavity. Despite reduced surgical trauma compared to the traditional thoracotomy approach, patients continued to experience moderate to severe postoperative pain. Pain medication such as opioids is commonly utilized for postoperative pain control but is associated with side effects. The use of nerve blocks, such as the recently described erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has the potential to improve patient recovery and decrease the risk of pulmonary complication. This study aims to investigate the analgesic effect of ESPB in managing pain following VATS.

Conditions

Thoracic Surgery; Peripheral Nerve Block; Analgesia

Outcome Measures

Primary Outcomes (1)

• Opioid consumption in IV morphine equivalents

  All source of opioid

  First postoperative 24 hour

Secondary Outcomes (15)

• Opioid consumption in IV morphine equivalents

  Second postoperative 24 hours

• Area under curve of pain score

  First postoperative 24 hour

• Area under curve of pain score

  Second postoperative 24 hour

• Post-anesthetic recovery length of stay

  up to 12 hours

• Hospital length of stay

  Up to 1 week

Study Arms (2)

Sham Block

SHAM COMPARATOR

Patient will receive a single shot of normal saline 20 mL injected at the erector spinae plane

Drug: Normal saline

Erector Spinae Block

ACTIVE COMPARATOR

Patient will receive a single shot of Ropivacaine Injection \[Naropin\] 0.5% 20 mL injected at the erector spinae plane

Drug: Ropivacaine Injection [Naropin]

Interventions

Ropivacaine Injection [Naropin] DRUG

Ropivacaine will be injected in the erector spinae plane

Also known as: Erector spinae block

Erector Spinae Block

Normal saline DRUG

Normal saline will be injected in the erector spinae plane

Also known as: Sham block

Sham Block

Eligibility Criteria

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

You may qualify if:

• Adult patients
• Scheduled for an elective VATS
• American Society of Anesthesiologists (ASA) physical status I to III

You may not qualify if:

• Age \< 18
• BMI \> 40
• Patient refusal or inability to provide consent
• Chronic pain conditions
• Daily opioid use \> 60 mg of oral morphine equivalents
• Cognitive or psychiatric condition that makes it challenge to assess pain
• Conversion to open thoracotomy
• Allergy to any of the drugs used in this study
• Contraindication to nerve blocks such as infection, severe coagulopathy or pre-existing neuropathy
• Significant systemic cardiac, respiratory, hepatic or renal diseases
• Postoperative admission to intensive care unit

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Cheng Lin, FRCPC

CONTACT

5196858500; cheng.lin@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization sequence will be computer-generated. Allocation concealment will be carried out via concealed assignments in opaque, sealed, and consecutively numbered envelopes. Blinding will be achieved by sham blocks. After patient allocation, a research assistant not participating in the clinical care and outcome assessment will prepare a syringe of 30 mL 0.5% ropivacaine or normal saline labeled "study drug" which will then be passed on to one of the investigators (CL or KK) who are blinded to patient allocation. Patients who are allocated to the "block" group (group B) will receive 0.5 ropivacaine with the ESPB while the "control" group (group C) will receive normal saline. In addition to ESPB, both group will receive multimodal systemic analgesia including acetaminophen, non-steroidal anti-inflammatory medication and an intravenous (IV) opioid patient-controlled analgesia (PCA) that provides IV opioids on patient-demand.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study will be a single center (Victoria Hospital), prospective randomized, patient and assessor blinded randomized controlled trial.

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 14, 2018
• Study Start: September 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: January 1, 2021
• Last Updated: June 24, 2019

Record last verified: 2019-06