Pain, AcuteNCT05181371
ESP Block in VATS: Programmed Intermittent Bolus Versus Continuous Infusion on Quality of Recovery
A study testing Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS and Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS in people with Pain, Acute and Surgery, run by Mater Misericordiae University Hospital at 2 sites in Ireland.
Trial summary
Fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Acute, Surgery
- What is being tested?
- Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS and Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIreland
- Study dates
- 2 Jun 2022to 1 Aug 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female aged > 18
- Able to provide written informed consent
- ASA grade I - V
- VATS surgery
- Weight > 55kg
Who cannot join
- Absence of or inability to give informed consent
- Pre-existing infection at block site
- Severe coagulopathy
- Allergy to local anaesthesia (or another contraindication to block performance)
- Previous history of opiate abuse
- Pre-existing chronic pain condition
Show all 9Show fewer
- Pre-existing dementia (due to need to co-operate in completing QoR-15 score day after surgery
- Postoperative admission to ICU for continued ventilation
- BMI > 40 kg/m2
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Mater Misericordiae University Hospital
Dublin, D07 R2WY
St Jame's University Hospital
Dublin, D08 NHy1
About this study
Official title: Ultrasound Guided, Continuous Erector Spinae Plane (ESP) Block in Minimally Invasive Thoracic Surgery: Comparing Programmed Intermittent Bolus (PIB) vs Continuous Infusion on Quality of Recovery and Postoperative Respiratory Function
Fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for Erector Spinae Plane Block for MITS in terms of patient centred outcomes such as quality of recovery.
Read the detailed description
Minimally invasive thoracic surgery (MITS) has been shown to reduce postoperative pain, reduce tissue trauma and contribute to better recovery as compared to open thoracotomy. However, it still causes significant acute post-operative pain. Our Mater research group has shown that fascial plane blocks such as the Erector Spinae Plane block (ESP) contribute to post-operative analgesia after MITS. Case reports have described the improved quality of analgesia following ESP using programmed intermittent boluses (PIB) instead of continuous infusion. It is hypothesised that larger, repeated bolus doses provide superior analgesia, possibly as a result of improved spread of the local anaesthetic. Evidence for improved spread of local anaesthetic may be found in one study which demonstrated that PIB increased the number of affected dermatomal levels compared to continuous infusions for continuous paravertebral blocks. Similarly, with regard to labour epidural analgesia, PIB provides better analgesia compared with continuous infusion.
Because fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To the best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for Erector Spinae Plane Block for MITS in terms of patient-centered outcomes such as quality of recovery.
- Conditions
- Pain, Acute, Surgery
- Being tested
- Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS, Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS
- Keywords
- Regional Anesthesia, Erector Spinae Block, VATS, Quality of Recovery, Acute pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATSProcedure or surgery
Programmed Intermittent Bolus (PIB) of Levobupivacaine
Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATSProcedure or surgery
Continuous Infusion (CI) of Levobupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) | Active comparator | After induction of general anaesthesia, an ESP catheter will be inserted at the level of T5. A bolus dose of 20 ml 0.25% Levobupicaine will be administered into the ESP space. Two hours post bolus administration, patients will receive programmed intermittent bolus of local anaesthetic: 20mls 0.125% levobupivacaine every two hours. Receives: Procedure: Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS |
| Ultrasound Guided ESP Block with Continuous Infusion (CI) | Active comparator | After induction of general anaesthesia, an ESP catheter will be inserted at the level of T5. A bolus dose of 20 ml 0.25% Levobupicaine will be administered into the ESP space. Two hours post bolus administration, patients will receive a continuous infusion local anaesthetic: 0.125% levobupivacaine at an infusion rate of 10 ml/hr. Receives: Procedure: Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery (QoR-15)
Patient centred metric to measure the quality of recovery after surgery. Scale is between 0-150, where '0' refers to poor quality of recovery and '150' refers to excellent quality of recovery
Measured: 24 hours
Secondary outcomes (8)
Maximal inspiratory volume
This will be measured with a calibrated incentive spirometer at the bedside
Measured: 48 hours
Area Under the Curve for Verbal Rating Score for pain at rest
Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
Measured: 48 hours
Area Under the Curve for Verbal Rating Score for pain on deep inspiration
Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
Measured: 48 hours
Time to first intravenous opioid
Will be measured from immediate postoperative in minutes
Measured: 48 hours
Time to first mobilisation
Will be measured from immediate postoperative in hours
Measured: 48 hours
Duration of time in PACU .
Will be measured from immediate postoperative in minutes
Measured: 24 hours
Length of hospital stay
Will be measured from immediate postoperative in days
Measured: 30 days
Quality of Recovery (QoR-15)
Patient centred metric to measure the quality of recovery after surgery. Scale is between 0-150, where '0' refers to poor quality of recovery and '150' refers to excellent quality of recovery
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start2 Jun 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mater Misericordiae University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aneurin Moorthy, Mater Misericordiae University Hospital
- Investigators
- Donal Buggy, Principal investigator, Mater University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181371
- Sponsor's protocol ID
- ESP2
- Status last verified
- Sep 2023
- First submitted
- 19 Dec 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Patient Data sharing will be supported with qualified external researchers and supporting clinical documents from eligible studies. All data provided will be coded and anonymised to respect the privacy of patients who have participated in the trial.
Publications
Finnerty D, Ni Eochagain A, Ahmed M, Poynton A, Butler JS, Buggy DJ. A randomised trial of bilateral erector spinae plane block vs. no block for thoracolumbar decompressive spinal surgery. Anaesthesia. 2021 Nov;76(11):1499-1503. doi: 10.1111/anae.15488. Epub 2021 Apr 20.
PubMed 33878196Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.
PubMed 32660716Onuoha OC. Epidural Analgesia for Labor: Continuous Infusion Versus Programmed Intermittent Bolus. Anesthesiol Clin. 2017 Mar;35(1):1-14. doi: 10.1016/j.anclin.2016.09.003. Epub 2016 Dec 12.
PubMed 28131113Ilfeld BM, Gabriel RA. Basal infusion versus intermittent boluses for perineural catheters: should we take the 'continuous' out of 'continuous peripheral nerve blocks'? Reg Anesth Pain Med. 2019 Mar;44(3):285-286. doi: 10.1136/rapm-2018-100262. Epub 2019 Jan 13. No abstract available.
PubMed 30636717Eochagain AN, Moorthy A, O'Gara A, Buggy DJ. Ultrasound-guided, continuous erector spinae plane (ESP) block in minimally invasive thoracic surgery-comparing programmed intermittent bolus (PIB) vs continuous infusion on quality of recovery and postoperative respiratory function: a double-blinded randomised controlled trial. Trials. 2022 Sep 21;23(1):792. doi: 10.1186/s13063-022-06726-7.
PubMed 36131308
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided, Continuous Erector Spinae Plane (ESP) Block in Minimally Invasive Thoracic Surgery: Comparing Programmed Intermittent Bolus (PIB) vs Continuous Infusion on Quality of Recovery and Postoperative Respiratory Function
- ClinicalTrials.gov ID
- NCT05181371
- Acronym / sponsor ID
- ESP2
- Conditions
- Pain, Acute, Surgery
- Keywords
- Regional Anesthesia, Erector Spinae Block, VATS, Quality of Recovery, Acute pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mater Misericordiae University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 6 Jan 2022 (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.
Fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for Erector Spinae Plane Block for MITS in terms of patient centred outcomes such as quality of recovery.
Detailed description
Minimally invasive thoracic surgery (MITS) has been shown to reduce postoperative pain, reduce tissue trauma and contribute to better recovery as compared to open thoracotomy. However, it still causes significant acute post-operative pain. Our Mater research group has shown that fascial plane blocks such as the Erector Spinae Plane block (ESP) contribute to post-operative analgesia after MITS. Case reports have described the improved quality of analgesia following ESP using programmed intermittent boluses (PIB) instead of continuous infusion. It is hypothesised that larger, repeated bolus doses provide superior analgesia, possibly as a result of improved spread of the local anaesthetic. Evidence for improved spread of local anaesthetic may be found in one study which demonstrated that PIB increased the number of affected dermatomal levels compared to continuous infusions for continuous paravertebral blocks. Similarly, with regard to labour epidural analgesia, PIB provides better analgesia compared with continuous infusion.
Because fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To the best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for Erector Spinae Plane Block for MITS in terms of patient-centered outcomes such as quality of recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) | Active comparator | Procedure: Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATSAfter induction of general anaesthesia, an ESP catheter will be inserted at the level of T5. A bolus dose of 20 ml 0.25% Levobupicaine will be administered into the ESP space. Two hours post bolus administration, patients will receive programmed intermittent bolus of local anaesthetic: 20mls 0.125% levobupivacaine every two hours. |
| Ultrasound Guided ESP Block with Continuous Infusion (CI) | Active comparator | Procedure: Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATSAfter induction of general anaesthesia, an ESP catheter will be inserted at the level of T5. A bolus dose of 20 ml 0.25% Levobupicaine will be administered into the ESP space. Two hours post bolus administration, patients will receive a continuous infusion local anaesthetic: 0.125% levobupivacaine at an infusion rate of 10 ml/hr. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and Female aged > 18
- Able to provide written informed consent
- ASA grade I - V
- VATS surgery
- Weight > 55kg
Key exclusion criteria (9 listed)
- Absence of or inability to give informed consent
- Pre-existing infection at block site
- Severe coagulopathy
- Allergy to local anaesthesia (or another contraindication to block performance)
- Previous history of opiate abuse
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 |
|---|---|---|
| Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATSProgrammed Intermittent Bolus (PIB) of Levobupivacaine | Procedure or surgery | Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) |
| Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATSContinuous Infusion (CI) of Levobupivacaine | Procedure or surgery | Ultrasound Guided ESP Block with Continuous Infusion (CI) |
Primary outcome
Quality of Recovery (QoR-15)
Time frame: 24 hours
Patient centred metric to measure the quality of recovery after surgery. Scale is between 0-150, where '0' refers to poor quality of recovery and '150' refers to excellent quality of recovery
8 secondary outcomes
Maximal inspiratory volume
Time frame: 48 hours
Area Under the Curve for Verbal Rating Score for pain at rest
Time frame: 48 hours
Area Under the Curve for Verbal Rating Score for pain on deep inspiration
Time frame: 48 hours
Time to first intravenous opioid
Time frame: 48 hours
Time to first mobilisation
Time frame: 48 hours
Duration of time in PACU .
Time frame: 24 hours
Length of hospital stay
Time frame: 30 days
Quality of Recovery (QoR-15)
Time frame: 48 hours
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 21 Sep 2023.
- Background: PubMed 33878196Finnerty D, Ni Eochagain A, Ahmed M, Poynton A, Butler JS, Buggy DJ. A randomised trial of bilateral erector spinae plane block vs. no block for thoracolumbar decompressive spinal surgery. Anaesthesia. 2021 Nov;76(11):1499-1503. doi: 10.1111/anae.15488. Epub 2021 Apr 20.
- Background: PubMed 32660716Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.
- Background: PubMed 28131113Onuoha OC. Epidural Analgesia for Labor: Continuous Infusion Versus Programmed Intermittent Bolus. Anesthesiol Clin. 2017 Mar;35(1):1-14. doi: 10.1016/j.anclin.2016.09.003. Epub 2016 Dec 12.
- Background: PubMed 30636717Ilfeld BM, Gabriel RA. Basal infusion versus intermittent boluses for perineural catheters: should we take the 'continuous' out of 'continuous peripheral nerve blocks'? Reg Anesth Pain Med. 2019 Mar;44(3):285-286. doi: 10.1136/rapm-2018-100262. Epub 2019 Jan 13. No abstract available.
- Derived from this study: PubMed 36131308Eochagain AN, Moorthy A, O'Gara A, Buggy DJ. Ultrasound-guided, continuous erector spinae plane (ESP) block in minimally invasive thoracic surgery-comparing programmed intermittent bolus (PIB) vs continuous infusion on quality of recovery and postoperative respiratory function: a double-blinded randomised controlled trial. Trials. 2022 Sep 21;23(1):792. doi: 10.1186/s13063-022-06726-7.
- ESP vs PVBLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual Patient Data sharing will be supported with qualified external researchers and supporting clinical documents from eligible studies. All data provided will be coded and anonymised to respect the privacy of patients who have participated in the trial.
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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.
Donal Buggy principal investigator
Mater University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS and Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS in people with Pain, Acute and Surgery, run by Mater Misericordiae University Hospital at 2 sites in Ireland.
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 9 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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?
Quality of Recovery (QoR-15) (time frame: 24 hours). 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 NCT05181371, 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 21 Sep 2023.