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Thoracic SurgeryPhase 3NCT03628040

Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery

A Phase 3 study testing Ropivacaine Injection [Naropin] and Normal saline in people with Thoracic Surgery and Peripheral Nerve Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ropivacaine Injection [Naropin] and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
No sites listed yet
Study dates
1 Sep 2019to 1 Jan 2021
Phase
Phase 3
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

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

About this study

Official title: Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial

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.

Read the detailed description

VATS is a minimally invasive surgical technique to remove intrathoracic lesions. Using a camera based scope and specifically designed instruments, the surgery can be initiated with three "key-hole" sized incisions. At the end of the surgery, an incision is enlarged to allow removal of surgical specimen. Chest tubes are inserted at the end of procedure and sutured in between the ribs.

While acute pain after VATS is less than the traditional thoracotomy, patients still experience moderate amount of pain within the first 24 hours. Source of pain may be from diaphragm irritation, surgical incisions and chest tubes. Because of its origin on the chest wall, pain from VATS worsens with breathing. When pain is poorly controlled, it will lead to a shallow breathing pattern called "splinting" and this can progress to respiratory distress or failure. Given the high incidence of smoking history in this patient population, many would have presented with poor baseline respiratory function. Therefore, it is important to provide good pain control to allow deep breathing and cough to reduce respiratory complications[1][2].

Despite the smaller incisions, the incidence of chronic post-surgical pain (CPSP) after VATS is surprisingly similar to thoracotomy. The mechanism may be due to nerve compression by the trocar, an instrument inserted between the ribs to allow smooth manipulation of camera and surgical instruments in the thoracic cavity. Additionally, poorly controlled acute pain has also been postulated to lead to the development of CPSP, further emphasizing the importance of good analgesia[1].

Many regional analgesia techniques have been tried to improve postoperative analgesia. Thoracic epidural analgesia (TEA) remains the gold standard of pain control after thoracic surgery. Although it provides superior analgesia, its use is hindered by the rare but serious complication of epidural hematoma and abscess which may cause paralysis. Further, pain from VATS tends to be short-lived (less than 24 hours), making the risk to benefit ratio less ideal for TEA. An alternative to TEA is paravertebral block (PVB). Compared to TEA, it causes less hypotension and hematoma or abscess at the paravertebral space may be less consequential. Nevertheless, PVB is a deep block and is technically demanding which limits its wide adoption[3].

Erector spinae plane block (ESPB) is a novel nerve block that has been used for analgesia for surgeries of the chest and abdominal wall. Using a bony structure, the transverse process, as the end point, the block needle is very unlikely to cause injury to vital structures as is possible with TEA or PVB (for examples, the spinal cord, lungs and blood vessels). It is also technically easy to perform. ESPB has only been reported in case series but so far, no adverse events such as hypotension, hematoma or infection has been reported. ESPB has also showed promise in managing CPSP after thoracic surgery in a small case series[4].

Given its safety, ease of performance and efficacy, the study aims to study the analgesic efficacy of ESPB in addition to systemic analgesia compared to systemic analgesia alone in patients undergoing VATS. The hypothesis is that ESPB and systemic analgesia will provide better analgesia when compared to systemic analgesia alone.

Being tested
Ropivacaine Injection [Naropin], Normal saline
Medical subject headings
Agnosia

What participants receive

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

  • Ropivacaine Injection [Naropin]Drug

    Also called Erector spinae block

    Ropivacaine will be injected in the erector spinae plane

  • Normal salineDrug

    Also called Sham block

    Normal saline will be injected in the erector spinae plane

Study groups in NCT03628040
Study groupRoleWhat they receive
Sham BlockSham comparatorPatient will receive a single shot of normal saline 20 mL injected at the erector spinae plane
Receives: Drug: Normal saline
Erector Spinae BlockActive comparatorPatient will receive a single shot of Ropivacaine Injection [Naropin] 0.5% 20 mL injected at the erector spinae plane
Receives: Drug: Ropivacaine Injection [Naropin]

What is being measured

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

  1. Opioid consumption in IV morphine equivalents

    All source of opioid

    Measured: First postoperative 24 hour

Secondary outcomes (15)
  1. Opioid consumption in IV morphine equivalents

    All source of opioid

    Measured: Second postoperative 24 hours

  2. Area under curve of pain score

    0 - 10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)

    Measured: First postoperative 24 hour

  3. Area under curve of pain score

    0 - 10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)

    Measured: Second postoperative 24 hour

  4. Post-anesthetic recovery length of stay

    In minutes

    Measured: up to 12 hours

  5. Hospital length of stay

    in hours

    Measured: Up to 1 week

  6. Incidence of nausea

    patient reported sensation of nausea related to opioid intake

    Measured: Up to 1 week

  7. Incidence of vomiting

    nurse recorded incidence of vomiting related to opioid intake

    Measured: Up to 1 week

  8. Incidence of drowsiness

    lightheadedness, drowsiness reported by patient related to opioid intake

    Measured: Up to 1 week

  9. Incidence of pruritus

    new onset of pruritus related to opioid intake

    Measured: Up to 1 week

  10. Incidence of infection at block injection site

    defined as redness, swelling, tenderness and/or prurulent discharge

    Measured: Up to 1 week

  11. Incidence of symptomatic hematoma at block injection site

    collection of blood confirmed by ultrasound

    Measured: Up to 1 week

  12. Incidence of paresthesia in the area covered by block

    paresthesia, decreased sensation thought to related to block

    Measured: Up to 1 week

  13. Incidence of hypoxia

    hypoxia (SaO2 < 90%) despite > 5 L oxygen

    Measured: during the first 24 hours

  14. Incidence of mechanical ventilation

    requiring re-intubation

    Measured: during the first 24 hours

  15. Incidence of tachypnea

    Respiratory rate more than 30 for more than 2 hours

    Measured: during the first 24 hours

Timeline

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

  1. First posted14 Aug 2018
  2. Study start1 Sep 2019 (estimated)
  3. Primary completion1 Oct 2020 (estimated)
  4. Study completion1 Jan 2021 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will be a single center (Victoria Hospital), prospective randomized, patient and assessor blinded randomized controlled trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03628040
Sponsor's protocol ID
112452
Status last verified
Jun 2019
First submitted
25 Jul 2018
Last updated
24 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ropivacaine Injection [Naropin] and Normal saline in people with Thoracic Surgery and Peripheral Nerve Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.

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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Cheng Lin, FRCPC (5196858500 ext. 55115, cheng.lin@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid consumption in IV morphine equivalents (time frame: First postoperative 24 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 24 Jun 2019.

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