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Post-operative PainNCT03176667

Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing VATS Lobectomy

A study testing Ultrasound guided erector spinae plane block and Intercostal block in people with Post-operative Pain, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare ESP block plus patient-controlled analgesia (PCA) to intercostal nerve block plus PCA as post-operative pain control for patients having video-assisted thorascopic surgeries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-operative Pain
What is being tested?
Ultrasound guided erector spinae plane block and Intercostal block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
6 Dec 2018to 15 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Elective video-assisted thoracoscopic surgeries (VATS) lobectomies
  • Elective video-assisted thoracoscopic surgeries (VATS) wedge resections

Who cannot join

  • Patient refusal
  • Contraindications to regional anesthesia
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Use of any anti-coagulants
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Inability to operate PCA system

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS) Lobectomy or Wedge Resections - a Pilot Randomized Control Trial

This study will compare ESP block plus patient-controlled analgesia (PCA) to intercostal nerve block plus PCA as post-operative pain control for patients having video-assisted thorascopic surgeries.

Read the detailed description

Video assisted thoracoscopic surgery (VATS) has become an increasingly popular technique in thoracic surgery with improvement in technology. It provides significant advantages over open thoracotomy procedures including reduced acute pain, reduced mortality, improved post-operative pulmonary function, and shorter hospitalization stays. Nevertheless, there is still considerable amount of post-operative acute pain with VATS lobectomies. Controlling post-operative pain is crucial because increased acute pain has been associated with the development of chronic pain.

Many patients receive either thoracic epidural (TEA) or paravertebral blocks (PVB) to treat post-operative pain in thoracotomy procedures as these techniques remain the gold standard. In contrast to thoracotomy procedures, it is unclear which is the best approach to analgesia is in VATS. A few studies have found no benefit in pain scores, patient satisfaction, pulmonary function, and incidence of side effects when comparing TEA with opioid patient controlled analgesia in VATS. Other studies have found minimal benefit in pain scores with TEA. The PVB has been used as alternative to TEA. One prospective observational study using PVB and continuous intercostal catheter demonstrated lower pain scores in VATS lobectomy. A randomized control trial (RCT) comparing PVB with wound infiltration in VATS lobectomy showed lower pain scores, lower morphine consumption, and higher patient satisfaction. However, both TEA and PVB have potential serious side-effects and complications. Complications of TEA include severe hypotension, epidural abscess, epidural hematomas and spinal cord injury. PVB have less incidence of hypotension but may involve risks like pneumothorax, pleural and vascular puncture, and higher systemic absorption of local anesthetics. PVB is also technically challenging and its spread is not reliable likely due to the presence of the endothoracic fasica. In addition, placement of both TEA and PVB require appropriate discontinuation of anticoagulants. Intercostal nerve blocks have been used as an analgesic alternative to TEA and PVB. One RCT found patients who had received intercostal blocks undergoing bilateral VATS for hyperhidrosis had lower pain scores in the post-anesthesia recovery unit (PACU). A combined retrospective and prospective study examined the analgesic effect and duration of intercostal blocks in patients undergoing VATS. The authors found that intercostal blocks decreased morphine consumption in the first 24 hours and the analgesic effect of the block lasted approximately 16 hours. Intercostal blocks appear to have some analgesic effect in the immediate post-operative period but are short-lived unless a catheter is placed. The standard practice for post-operative pain management for VATS lobectomy at St. Joseph's hospital consists of intercostal blocks performed by the thoracic surgeons at the end of surgery in combination with patient-controlled analgesia (PCA).

A novel regional technique called the Erector Spinae Plane (ESP) block has been recently described. This interfascial block involves ultrasound guided injection of local anesthetics posterior to the erector spinae muscle and superficial to transverse process of thoracic vertebrae at appropriate level. The ESP block appears to target the dorsal and ventral rami of the spinal nerves as they leave the intervertebral foramen. Cadaveric examination of ESP block showed extensive cranial-caudal spread of the block, approximately four dermatomes above and below the site of injection. The ESP block has been successfully applied in multiple clinical settings. For example, several patients suffering from chronic thoracic neuropathic pain achieved significant analgesia after receiving ESP blocks. ESP blocks have also been used as a rescue analgesia for a patient who failed a TEA after thoracotomy. Other applications include ventral hernia repair in abdominal surgery. The simplicity and safety of the ESP block has been proposed as its main advantages. Because it is a superficial interfascial plane block, it is distant from both the spinal cord and pleura. The ESP block is technically an easy to perform under ultrasound guidance due to its superficial location. There is also theoretically less possibility of needle related complications as the transverse process acts as a backstop for needle advancement. A catheter can be placed easily during the ESP block allowing continuous infusion and prolonged analgesia.

Given the importance of providing adequate analgesia in VATS lobectomy and wedge resections and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, the investigators are proposing a prospective observational study to examine the analgesic efficacy of the ESP block in VATS lobectomy or wedge resections as a potential alternative to TEA, PVB and intercostal blocks. The investigators are hoping the results of this study will provide framework for future larger comparative studies.

Being tested
Ultrasound guided erector spinae plane block, Intercostal block
Keywords
regional, erector spinae block, lobectomy, video-assisted
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided erector spinae plane blockProcedure or surgery

    A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T5 spinous process. The trapezius, rhomboid major, and erector spinae muscles will then be identified superficial to the tip of the T5 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.5% ropivacaine with 5mcg/mL of epinephrine will be injected in 5-mL aliquots through the needle (maximum of 3mg/kg), followed by insertion of a 19-gauge catheter under direct vision 5 cm beyond the needle tip. The catheter will then be secured in place.

  • Intercostal blockProcedure or surgery

    The surgeons will identify the desired rib, and advance the needle at an approximately 20-degree angle until contact with rib is made, the needle is then walked of the inferior border of the rib and advanced slightly to plaice the tip of the needle in the neurovascular bundle. The intercostal nerve blocks will be performed at T4-T11 using 0.25% Marcaine with epinephrine and a volume of 5 ml per block (maximum of 2.5mg/kg) after negative aspiration has been confirmed.

Study groups in NCT03176667
Study groupRoleWhat they receive
ESP for VATSExperimentalErector Spinae plane (ESP) block
Receives: Procedure: Ultrasound guided erector spinae plane block
ICB for VATSActive comparatorIntercostal block (ICB)
Receives: Procedure: Intercostal block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility comparing two regional techniques in VATS surgery which is defined as the number of patients recruited per week.

    Number of patients recruited per week

    Measured: One week

  2. Number of adverse events (AEs) which can be attributed to the ESP block which is defines as the number of AEs occuring per week.

    Number of adverse events

    Measured: One week

Secondary outcomes (2)
  1. Pain scores at rest and on movement

    Pain scores will be recorded at intervals

    Measured: Two days post-operatively

  2. Dermatome distribution to test loss of sensation to pinpricks

    The dermatome distribution on the patient's anterior chest, mid-axillary line and back will be collected using a blunt needle to test for loss of sensation to pinpricks.

    Measured: Two days post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start6 Dec 2018
  3. Primary completion30 Mar 2019
  4. Study completion15 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03176667
Sponsor's protocol ID
3012
Status last verified
Aug 2026
First submitted
24 May 2017
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Joshi GP, Bonnet F, Shah R, Wilkinson RC, Camu F, Fischer B, Neugebauer EA, Rawal N, Schug SA, Simanski C, Kehlet H. A systematic review of randomized trials evaluating regional techniques for postthoracotomy analgesia. Anesth Analg. 2008 Sep;107(3):1026-40. doi: 10.1213/01.ane.0000333274.63501.ff.

    PubMed 18713924
  • Demmy TL, Curtis JJ. Minimally invasive lobectomy directed toward frail and high-risk patients: a case-control study. Ann Thorac Surg. 1999 Jul;68(1):194-200. doi: 10.1016/s0003-4975(99)00467-1.

    PubMed 10421140
  • Kim JA, Kim TH, Yang M, Gwak MS, Kim GS, Kim MJ, Cho HS, Sim WS. Is intravenous patient controlled analgesia enough for pain control in patients who underwent thoracoscopy? J Korean Med Sci. 2009 Oct;24(5):930-5. doi: 10.3346/jkms.2009.24.5.930. Epub 2009 Sep 23.

    PubMed 19794994
  • Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.

    PubMed 22219442
  • Horth D, Sanh W, Moisiuk P, O'Hare T, Shargall Y, Finley C, Hanna W, Agzarian J, Forero M, Davis K, Vanniyasingam T, Thabane L, Shanthanna H. Continuous erector spinae plane block versus intercostal nerve block in patients undergoing video-assisted thoracoscopic surgery: a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Feb 24;7(1):56. doi: 10.1186/s40814-021-00801-7.

    PubMed 33627193

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided erector spinae plane block and Intercostal block in people with Post-operative Pain, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility comparing two regional techniques in VATS surgery which is defined as the number of patients recruited per week. (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03176667, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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