Post Operative PainNCT05494125
Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery
A study testing Ropivacaine in people with Post Operative Pain and Spine Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Single-shot erector spinae plane (ESP) blocks (ESPB) are emerging as an intervention to improve pain and minimize opioid consumption after lumbar spine surgery. Although promising, there is minimal evidence to support routine use, and widespread clinical adoption may be limited to centers with advanced regional… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Spine Surgery
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 18 Mar 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80
- Presenting for elective multilevel (>2 spinal levels) spinal fusion
- Lumbar, thoracic, and thoracolumbar procedures included
- Posterior surgical approach
- Willing and able to follow the study protocol
- Able to provide informed consent
Who cannot join
- Opioid tolerance (more than 60 morphine milliequivalents daily for more than 3 months)
- Daily gabapentin/pregabalin use for longer than 3 months
- Prior spine surgery at the index level
- Allergy or contraindication (including renal, liver disease) to included study medications
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Effects of Continuous Erector Spinae Plane Blocks on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery: A Prospective Randomized Clinical Trial
Single-shot erector spinae plane (ESP) blocks (ESPB) are emerging as an intervention to improve pain and minimize opioid consumption after lumbar spine surgery. Although promising, there is minimal evidence to support routine use, and widespread clinical adoption may be limited to centers with advanced regional anesthesia resources and expertise. Continuous ESP catheter techniques may solve these problems but are associated with challenges of their own. This trial will investigate the role of adding surgeon-placed, continuous ESP catheters to single-shot ESPBs for patients undergoing multilevel spine surgery. It will assess whether adding ESP catheters with ropivacaine infusion for 48 hours after surgery offers opioid-minimizing analgesia and improves patient quality of recovery, compared to ESP catheters with saline/placebo infusion for 48 hours.
- Conditions
- Post Operative Pain, Spine Surgery
- Being tested
- Ropivacaine, 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.
RopivacaineOther
Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters
PlaceboOther
Patients will receive a continuous infusion of saline solution through bilateral ESP catheters
| Study group | Role | What they receive |
|---|---|---|
| ESP Catheters with Ropivacaine 0.2% | Experimental | Not described Receives: Other: Ropivacaine |
| ESP Catheters with Saline Solution | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)
Measured: First 72 hours after surgery
Secondary outcomes (10)
Duration of use and dose of opioid-iv-pca (if required)
Measured in morphine equivalents daily
Measured: First 72 hours after surgery
Post-operative opioid consumption
Measured in morphine equivalents daily
Measured: From PACU arrival to 72 hours post surgery
Numeric rating scale (NRS) pain scores: every 8 hours
Scale of 0-10, 0 being no pain, 10 being the worst pain possible
Measured: Between PACU and 72 hours post surgery
Quality of Recovery 15 (QoR15) scores
The Quality of Recovery 15 (QoR15) is a 15-item questionnaire which assesses five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. It has a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Measured: Pre-operative, holding area/day of surgery, 24 hours, 48 hours, 14 days and 42 days post surgery
Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement
Measured in days after placement
Measured: First 48 hours post surgery
Total dose of ropivacaine delivered
Measured in mg/kg/hr
Measured: First 48 hours post surgery
Opioid-related side effects (nausea, vomiting, anti-emetic medication administration, constipation, sedation, administration of naloxone)
If the patient ever had any of the events
Measured: First 48 hours post surgery
Length of hospital stay
Measured in days after surgery
Measured: From PACU arrival to hospital discharge, up to 2 weeks
Patient satisfaction scale with pain management and ESP catheters
Patient satisfaction will be assessed using a 0 to 10 scale (0 being not satisfied to 10 being totally satisfied)
Measured: First 72 hours, 14 days, and 42 days post surgery
Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery
Measured with a 7-item questionnaire to assess chronic pain and opioid use
Measured: 3 and 6 month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start14 Sep 2022
- Primary completion31 Dec 2023
- Study completion18 Mar 2024
Why it stopped: Unanticipated adverse events occurred in 2 participants
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 Post Operative PainStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494125
- Sponsor's protocol ID
- 2021-1815
- Status last verified
- Apr 2024
- First submitted
- 15 Jul 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amoroso K, Hughes AP, Sama AA, Cammisa FP, Shue J, Soffin EM. Continuous erector spinae plane catheters leading to unwanted neuraxial spread after spinal fusion surgery: a report of two cases from a terminated prospective randomized clinical trial. Reg Anesth Pain Med. 2023 Sep;48(9):478-481. doi: 10.1136/rapm-2023-104587. Epub 2023 May 16.
PubMed 37192785
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Erector Spinae Plane Blocks on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05494125
- Acronym / sponsor ID
- 2021-1815
- Conditions
- Post Operative Pain, Spine Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unanticipated adverse events occurred in 2 participants
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 9 Aug 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.
Single-shot erector spinae plane (ESP) blocks (ESPB) are emerging as an intervention to improve pain and minimize opioid consumption after lumbar spine surgery. Although promising, there is minimal evidence to support routine use, and widespread clinical adoption may be limited to centers with advanced regional anesthesia resources and expertise. Continuous ESP catheter techniques may solve these problems but are associated with challenges of their own. This trial will investigate the role of adding surgeon-placed, continuous ESP catheters to single-shot ESPBs for patients undergoing multilevel spine surgery. It will assess whether adding ESP catheters with ropivacaine infusion for 48 hours after surgery offers opioid-minimizing analgesia and improves patient quality of recovery, compared to ESP catheters with saline/placebo infusion for 48 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Catheters with Ropivacaine 0.2% | Experimental | Other: Ropivacaine |
| ESP Catheters with Saline Solution | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80
- Presenting for elective multilevel (>2 spinal levels) spinal fusion
- Lumbar, thoracic, and thoracolumbar procedures included
- Posterior surgical approach
- Willing and able to follow the study protocol
Key exclusion criteria (5 listed)
- Opioid tolerance (more than 60 morphine milliequivalents daily for more than 3 months)
- Daily gabapentin/pregabalin use for longer than 3 months
- Prior spine surgery at the index level
- Allergy or contraindication (including renal, liver disease) to included study medications
- Patient refusal
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 |
|---|---|---|
| RopivacainePatients will receive a continuous infusion of ropivacaine through bilateral ESP catheters | Other | ESP Catheters with Ropivacaine 0.2% |
| PlaceboPatients will receive a continuous infusion of saline solution through bilateral ESP catheters | Other | ESP Catheters with Saline Solution |
Primary outcome
Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)
Time frame: First 72 hours after surgery
10 secondary outcomes
Duration of use and dose of opioid-iv-pca (if required)
Time frame: First 72 hours after surgery
Post-operative opioid consumption
Time frame: From PACU arrival to 72 hours post surgery
Numeric rating scale (NRS) pain scores: every 8 hours
Time frame: Between PACU and 72 hours post surgery
Quality of Recovery 15 (QoR15) scores
Time frame: Pre-operative, holding area/day of surgery, 24 hours, 48 hours, 14 days and 42 days post surgery
Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement
Time frame: First 48 hours post surgery
Total dose of ropivacaine delivered
Time frame: First 48 hours post surgery
Opioid-related side effects (nausea, vomiting, anti-emetic medication administration, constipation, sedation, administration of naloxone)
Time frame: First 48 hours post surgery
Length of hospital stay
Time frame: From PACU arrival to hospital discharge, up to 2 weeks
Patient satisfaction scale with pain management and ESP catheters
Time frame: First 72 hours, 14 days, and 42 days post surgery
Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery
Time frame: 3 and 6 month post surgery
Results and safety
The study was stopped early (reason given: Unanticipated adverse events occurred in 2 participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 37192785Amoroso K, Hughes AP, Sama AA, Cammisa FP, Shue J, Soffin EM. Continuous erector spinae plane catheters leading to unwanted neuraxial spread after spinal fusion surgery: a report of two cases from a terminated prospective randomized clinical trial. Reg Anesth Pain Med. 2023 Sep;48(9):478-481. doi: 10.1136/rapm-2023-104587. Epub 2023 May 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Post Operative Pain and Spine Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 23 Apr 2024. 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 United States. 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 was stopped early (reason given: Unanticipated adverse events occurred in 2 participants). Results are not available in the source record.
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?
Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA) (time frame: First 72 hours 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 NCT05494125, 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 23 Apr 2024.