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.
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
- Conditions the study is for
- Thoracic Surgery, Peripheral Nerve Block, Analgesia
- 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.
- Conditions
- Thoracic Surgery, Peripheral Nerve Block, Analgesia
- 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 group | Role | What they receive |
|---|---|---|
| Sham Block | Sham comparator | Patient will receive a single shot of normal saline 20 mL injected at the erector spinae plane Receives: 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 Receives: Drug: Ropivacaine Injection [Naropin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption in IV morphine equivalents
All source of opioid
Measured: First postoperative 24 hour
Secondary outcomes (15)
Opioid consumption in IV morphine equivalents
All source of opioid
Measured: Second postoperative 24 hours
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
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
Post-anesthetic recovery length of stay
In minutes
Measured: up to 12 hours
Hospital length of stay
in hours
Measured: Up to 1 week
Incidence of nausea
patient reported sensation of nausea related to opioid intake
Measured: Up to 1 week
Incidence of vomiting
nurse recorded incidence of vomiting related to opioid intake
Measured: Up to 1 week
Incidence of drowsiness
lightheadedness, drowsiness reported by patient related to opioid intake
Measured: Up to 1 week
Incidence of pruritus
new onset of pruritus related to opioid intake
Measured: Up to 1 week
Incidence of infection at block injection site
defined as redness, swelling, tenderness and/or prurulent discharge
Measured: Up to 1 week
Incidence of symptomatic hematoma at block injection site
collection of blood confirmed by ultrasound
Measured: Up to 1 week
Incidence of paresthesia in the area covered by block
paresthesia, decreased sensation thought to related to block
Measured: Up to 1 week
Incidence of hypoxia
hypoxia (SaO2 < 90%) despite > 5 L oxygen
Measured: during the first 24 hours
Incidence of mechanical ventilation
requiring re-intubation
Measured: during the first 24 hours
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.
- First posted14 Aug 2018
- Study start1 Sep 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Lin, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03628040
- Acronym / sponsor ID
- 112452
- Conditions
- Thoracic Surgery, Peripheral Nerve Block, Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a single center (Victoria Hospital), prospective randomized, patient and assessor blinded randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Sham Block | Sham comparator | Drug: Normal salinePatient will receive a single shot of normal saline 20 mL injected at the erector spinae plane |
| Erector Spinae Block | Active comparator | Drug: Ropivacaine Injection [Naropin]Patient will receive a single shot of Ropivacaine Injection [Naropin] 0.5% 20 mL injected at the erector spinae plane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Scheduled for an elective VATS
- American Society of Anesthesiologists (ASA) physical status I to III
Key exclusion criteria (11 listed)
- Age < 18
- BMI > 40
- Patient refusal or inability to provide consent
- Chronic pain conditions
- Daily opioid use > 60 mg of oral morphine equivalents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine Injection [Naropin]Also: Erector spinae blockRopivacaine will be injected in the erector spinae plane | Drug | Erector Spinae Block |
| Normal salineAlso: Sham blockNormal saline will be injected in the erector spinae plane | Drug | Sham Block |
Primary outcome
Opioid consumption in IV morphine equivalents
Time frame: First postoperative 24 hour
All source of opioid
15 secondary outcomes
Opioid consumption in IV morphine equivalents
Time frame: Second postoperative 24 hours
Area under curve of pain score
Time frame: First postoperative 24 hour
Area under curve of pain score
Time frame: Second postoperative 24 hour
Post-anesthetic recovery length of stay
Time frame: up to 12 hours
Hospital length of stay
Time frame: Up to 1 week
Incidence of nausea
Time frame: Up to 1 week
Incidence of vomiting
Time frame: Up to 1 week
Incidence of drowsiness
Time frame: Up to 1 week
Incidence of pruritus
Time frame: Up to 1 week
Incidence of infection at block injection site
Time frame: Up to 1 week
Incidence of symptomatic hematoma at block injection site
Time frame: Up to 1 week
Incidence of paresthesia in the area covered by block
Time frame: Up to 1 week
Incidence of hypoxia
Time frame: during the first 24 hours
Incidence of mechanical ventilation
Time frame: during the first 24 hours
Incidence of tachypnea
Time frame: during the first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.