Regional AnesthesiaAnESThNCT03419117
Analgesic Efficacy of Single-shot Erector Spinae Block for Thoracic Surgery
A study testing ESP block in people with Regional Anesthesia and Pain, Postoperative, run by University of British Columbia at 1 site in Canada.
Trial summary
The erector spinae plane (ESP) block is a novel regional anesthetic technique for the treatment of thoracic, cervical, and abdominal pain. This pilot study aims to investigate the post-operative analgesic effectiveness of ultrasound guided single-shot ESP blocks for patients undergoing minimally invasive thoracoscopic… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia, Pain, Postoperative
- What is being tested?
- ESP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jul 2018to 31 Dec 2020
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years of age
- Presenting for elective thoracoscopic wedge resection
- Proficient in the use of the English language
- Able to provide informed consent
- Expected stay > 24 hrs in hospital
Who cannot join
- ASA greater than, or equal to 4
- Expected post-operative endotracheal intubation
- High likelihood of conversion to open thoracotomy
- A diagnosis of a chronic pain condition
- Depression or other psychiatric diagnosis
- Dementia
Show all 13Show fewer
- Pregnancy
- Preoperative opioid use >30mg of oral morphine equivalents per day
- Known alcohol or recreational drug abuse
- Contraindication to local anesthetic use including allergy or sensitivity to ropivacaine or other amide-type local anesthetics
- Contraindication to the ESP block or regional anesthetic technique including: allergy or sensitivity to ultrasound gel; previous spine instrumentation; previous rib surgery; injured, diseased, or infected skin overlying the area to be blocked
- Perioperative use, or planned use, of alternative regional anesthetic technique (not including surgical local anesthetic infiltration)
- Perioperative ketamine and lidocaine infusion use
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
Vancouver, British Columbia, V5Z 1L8
About this study
The erector spinae plane (ESP) block is a novel regional anesthetic technique for the treatment of thoracic, cervical, and abdominal pain. This pilot study aims to investigate the post-operative analgesic effectiveness of ultrasound guided single-shot ESP blocks for patients undergoing minimally invasive thoracoscopic wedge resections of the lung in comparison to those receiving conventional parental opioid analgesia alone. This will be achieved through the use of objective measures including quality the 40 point Quality of Recovery assessment (QoR-40) on postoperative day (POD) 1, visual-analogue pain scale (VAS) in the post-anesthetic care unit (PACU) and at POD 1, and oral morphine-equivalent (OME) opioid consumption in the PACU and at 24 hours post-operatively.
Read the detailed description
Purpose To investigate the postoperative analgesic effectiveness of the ultrasound-guided ESP block compared to a placebo injection for patients undergoing thoracoscopic wedge resection of the lung.
Hypothesis Thoracoscopic surgery patients who receive an ESP block in addition to current standard of care, consisting of parenteral and enteral opioids and surgical wound infiltration, will have a clinically significant improvement in their QoR-40 at POD 1 and lower pain levels, as measured by VAS in the PACU on arrival and one hour after, and on POD 1, and OME opioid consumption in the PACU and at 24 hours post-operatively, in comparison to those patients who receive the current standard of care along with a placebo injection.
Justification The ESP block is a novel regional anesthetic technique that has shown efficacy in the management of thoracic pain as published in numerous case reports and observational case series. To date, no randomized control trials exist of its efficacy in comparison to conventional parental opioid analgesic management. Thoracoscopic wedge resections of the lung are procedures not usually treated with regional analgesia techniques, but given the moderate pain experienced by many patients, this surgical population will serve as a proof-of-concept for the potential of improved post-operative analgesic and recovery profiles. Proof of analgesic efficacy in this setting may allow a future head-to-head comparison with more invasive analgesic techniques currently used for thoracic surgery such as epidural and paravertebral catheterizations.
In undertaking this aim, we will measure a number of different metrics. The 40-item Quality of Recovery Score (QoR-40) will be our primary objective as it provides a patient-centered global measure of overall health in the postoperative period. It has been tested for validity and reliability, and has undergone quantification for the minimal clinically important difference. Other traditional metrics of analgesic performance including the VAS and 24-hour post-op OME opioid consumption will also be monitored as secondary objectives.
Objectives
Primary Objective:
- Quality-of-Recovery 40 scale at POD 1.
Secondary Objectives:
- Cumulative OME opioid consumption intra-operatively and through PACU, and at 24 hours post operatively.
- Visual analog pain scale assessments post-operatively in PACU on arrival, after 1 hour, and at POD 1.
Research Design The study will be a prospective, single center, randomized, placebo-controlled pilot study requiring 2 patient visits for assessment in the PACU and on POD 1. One interim analysis for safety monitoring will be undertaken.
Sample Size Calculation and Statistical Methods No prior studies have been conducted to calculate an exact sample size calculation. Based on similar work, we will power this study on an expected difference of at least 10 points on the QoR-40 and a SD of 15 when comparing the block to placebo. This is a clinically meaningful difference. Assuming an alpha level of 0.05 and a power of 0.80, our sample size is 74. With a 10% dropout rate we will require recruitment of 82 patients. All outcomes will be analysed with the independent student t-test.
- Conditions
- Regional Anesthesia, Pain, Postoperative
- Being tested
- ESP block, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blockProcedure or surgery
An ESP block will be performed prior to surgery for postoperative pain control
PlaceboProcedure or surgery
A sham ESP block will be performed before surgery in the placebo group
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients in the experimental arm will receive an ESP block prior to induction of general anesthetic for their thoracoscopic wedge resection Receives: Procedure: ESP block |
| Placebo | Placebo comparator | Patients allocated to the placebo-control arm will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality-of-Recovery 40 (QoR-40) scale at POD 1.
The QoR-40 is a widely used and extensively validated measure of quality of recovery
Measured: Postoperative day 1. Will be completed on the ward 24hrs after surgery
Secondary outcomes (2)
Morphine usage
Cumulative morphine-equivalent opioid consumption intra-operatively, in PACU (post-anesthetic care unit) and at 24 hours.
Measured: 30 minutes post-operatively in the PACU and 24hr after surgery.
Visual analog pain scale (VAS) assessments post-operatively in PACU, and at POD 1.
Patients will rate their pain on a scale from 0-10 as per standard VAS pain scoring systems.
Measured: 30 minutes post-operatively in the PACU and 24hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start3 Jul 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Wilson, University of British Columbia
- Investigators
- Jason M Wilson, MD PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419117
- Sponsor's protocol ID
- H18-00029
- Acronym
- AnESTh
- Status last verified
- May 2021
- First submitted
- 12 Jan 2018
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klaibert B, Lohser J, Tang R, Jew M, McGuire A, Wilson J. Efficacy of ultrasound-guided single-injection erector spinae plane block for thoracoscopic wedge resection: a prospective randomized control trial. Reg Anesth Pain Med. 2022 Dec;47(12):749-754. doi: 10.1136/rapm-2022-103602. Epub 2022 Sep 23.
PubMed 36150741
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Single-shot Erector Spinae Block for Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03419117
- Acronym / sponsor ID
- AnESTh / H18-00029
- Conditions
- Regional Anesthesia, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Feb 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.
The erector spinae plane (ESP) block is a novel regional anesthetic technique for the treatment of thoracic, cervical, and abdominal pain. This pilot study aims to investigate the post-operative analgesic effectiveness of ultrasound guided single-shot ESP blocks for patients undergoing minimally invasive thoracoscopic wedge resections of the lung in comparison to those receiving conventional parental opioid analgesia alone. This will be achieved through the use of objective measures including quality the 40 point Quality of Recovery assessment (QoR-40) on postoperative day (POD) 1, visual-analogue pain scale (VAS) in the post-anesthetic care unit (PACU) and at POD 1, and oral morphine-equivalent (OME) opioid consumption in the PACU and at 24 hours post-operatively.
Detailed description
Purpose To investigate the postoperative analgesic effectiveness of the ultrasound-guided ESP block compared to a placebo injection for patients undergoing thoracoscopic wedge resection of the lung.
Hypothesis Thoracoscopic surgery patients who receive an ESP block in addition to current standard of care, consisting of parenteral and enteral opioids and surgical wound infiltration, will have a clinically significant improvement in their QoR-40 at POD 1 and lower pain levels, as measured by VAS in the PACU on arrival and one hour after, and on POD 1, and OME opioid consumption in the PACU and at 24 hours post-operatively, in comparison to those patients who receive the current standard of care along with a placebo injection.
Justification The ESP block is a novel regional anesthetic technique that has shown efficacy in the management of thoracic pain as published in numerous case reports and observational case series. To date, no randomized control trials exist of its efficacy in comparison to conventional parental opioid analgesic management. Thoracoscopic wedge resections of the lung are procedures not usually treated with regional analgesia techniques, but given the moderate pain experienced by many patients, this surgical population will serve as a proof-of-concept for the potential of improved post-operative analgesic and recovery profiles. Proof of analgesic efficacy in this setting may allow a future head-to-head comparison with more invasive analgesic techniques currently used for thoracic surgery such as epidural and paravertebral catheterizations.
In undertaking this aim, we will measure a number of different metrics. The 40-item Quality of Recovery Score (QoR-40) will be our primary objective as it provides a patient-centered global measure of overall health in the postoperative period. It has been tested for validity and reliability, and has undergone quantification for the minimal clinically important difference. Other traditional metrics of analgesic performance including the VAS and 24-hour post-op OME opioid consumption will also be monitored as secondary objectives.
Objectives
Primary Objective:
- Quality-of-Recovery 40 scale at POD 1.
Secondary Objectives:
- Cumulative OME opioid consumption intra-operatively and through PACU, and at 24 hours post operatively.
- Visual analog pain scale assessments post-operatively in PACU on arrival, after 1 hour, and at POD 1.
Research Design The study will be a prospective, single center, randomized, placebo-controlled pilot study requiring 2 patient visits for assessment in the PACU and on POD 1. One interim analysis for safety monitoring will be undertaken.
Sample Size Calculation and Statistical Methods No prior studies have been conducted to calculate an exact sample size calculation. Based on similar work, we will power this study on an expected difference of at least 10 points on the QoR-40 and a SD of 15 when comparing the block to placebo. This is a clinically meaningful difference. Assuming an alpha level of 0.05 and a power of 0.80, our sample size is 74. With a 10% dropout rate we will require recruitment of 82 patients. All outcomes will be analysed with the independent student t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: ESP blockPatients in the experimental arm will receive an ESP block prior to induction of general anesthetic for their thoracoscopic wedge resection |
| Placebo | Placebo comparator | Procedure: PlaceboPatients allocated to the placebo-control arm will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-75 years of age
- Presenting for elective thoracoscopic wedge resection
- Proficient in the use of the English language
- Able to provide informed consent
- Expected stay > 24 hrs in hospital
Key exclusion criteria (13 listed)
- ASA greater than, or equal to 4
- Expected post-operative endotracheal intubation
- High likelihood of conversion to open thoracotomy
- A diagnosis of a chronic pain condition
- Depression or other psychiatric diagnosis
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 |
|---|---|---|
| ESP blockAn ESP block will be performed prior to surgery for postoperative pain control | Procedure or surgery | Treatment |
| PlaceboA sham ESP block will be performed before surgery in the placebo group | Procedure or surgery | Placebo |
Primary outcome
Quality-of-Recovery 40 (QoR-40) scale at POD 1.
Time frame: Postoperative day 1. Will be completed on the ward 24hrs after surgery
The QoR-40 is a widely used and extensively validated measure of quality of recovery
2 secondary outcomes
Morphine usage
Time frame: 30 minutes post-operatively in the PACU and 24hr after surgery.
Visual analog pain scale (VAS) assessments post-operatively in PACU, and at POD 1.
Time frame: 30 minutes post-operatively in the PACU and 24hrs after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Derived from this study: PubMed 36150741Klaibert B, Lohser J, Tang R, Jew M, McGuire A, Wilson J. Efficacy of ultrasound-guided single-injection erector spinae plane block for thoracoscopic wedge resection: a prospective randomized control trial. Reg Anesth Pain Med. 2022 Dec;47(12):749-754. doi: 10.1136/rapm-2022-103602. Epub 2022 Sep 23.
- Individual participant dataSharing planned: No
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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.
Jason M Wilson, MD PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP block in people with Regional Anesthesia and Pain, Postoperative, run by University of British Columbia 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 5 inclusion and 13 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 11 May 2021. 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. 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.
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?
Quality-of-Recovery 40 (QoR-40) scale at POD 1. (time frame: Postoperative day 1. Will be completed on the ward 24hrs after surgery). 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 NCT03419117, which also lists 1 linked publication.
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 11 May 2021.