Opioid UsePhase 4ESPB-SpineNCT04156581
Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery
A Phase 4 study testing Bupivacaine, Dexamethasone and Saline in people with Opioid Use and Pain, Postoperative, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and analgesic choices to minimize opioid consumption while providing adequate pain control after surgery. Although ERPs for spine surgery are now being described, few pathways include regional analgesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid Use, Pain, Postoperative
- What is being tested?
- Bupivacaine, Dexamethasone and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 18 Jun 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Planned primary complex spine surgery: >2 level- lumbar and/or thoraco-lumbar spine fusion with or without decompression
- Planned stand-alone posterior surgical approach
- Able to follow study protocol
- Able to communicate in English (outcome questionnaires validated in English)
Who cannot join
- Age <18 or >80
- Revision surgery
- BMI > 35
- planned prolonged intubation/intubation overnight on night of surgery
- Unable to communicate in English
- History of chronic pain condition requiring gabapentin/pregabalin/antidepressant medication longer than 3 months
Show all 9Show fewer
- Opioid tolerance (>60 OME daily for >2 weeks)
- Allergy, intolerance or contraindication to any protocol component/study medication/technique
- Patient refusal of regional analgesia (ESPB)
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: Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery: A Randomized Controlled Trial
Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and analgesic choices to minimize opioid consumption while providing adequate pain control after surgery. Although ERPs for spine surgery are now being described, few pathways include regional analgesia. The Erector Spinae Plane Block (ESPB) may represent a novel opportunity to incorporate regional analgesia into ERPs for spine surgery. To date, there is minimal data to support the utility of ESPB in spine surgery, and this block has not yet been evaluated in complex spine surgery.
This study seeks to see whether ESPB will reduce opioid consumption and pain scores, and improve patient recovery during the first 24 hours after complex spine surgery when included in a comprehensive ERP.
Read the detailed description
Lumbar spinal fusion with posterior approach is a moderate-severely painful procedure requiring significant postoperative opioid analgesia (Mathiesen, 2013). There are limited opportunities to use multimodal analgesia (MMA) and regional analgesia after spine surgery. For example, non-steroidal anti-inflammatory drugs are not universally provided, due to concerns regarding bleeding and impaired fusion (Sivaganasan, 2017). Likewise, local anesthetic-based techniques may cause motor weakness and sensory changes which interfere with interpretation of the early postoperative neurological examination.
As in other orthopedic subspecialty surgeries, enhanced recovery pathways (ERPs) are now being described in spine surgery (Wang 2017; Soffin 2018; Soffin 2019a; Ali 2019). Published data emphasizes the importance of opioid-sparing MMA to achieve analgesia and minimize opioid-related side effects. However, with the exception of a report from our group, none include regional analgesia or field blocks as an element of care (Soffin 2019b). Further, comparative research regarding the benefits of regional analgesia within standardized ERPs is lacking for other surgical modalities - even within subspecialties where the evidence base to support such trials is more advanced. These deficits highlight an opportunity to demonstrate the unique advantages of regional analgesia over and above that which can be provided by conventional oral and/or intravenous MMA.
Ultrasound-guided erector spinae plane block (ESPB) may represent a novel opportunity to apply regional analgesia to patients undergoing spine surgery. First described in 2016, ESPB provides analgesia by depositing local anesthetic deep to the erector spinae muscles (Forero 2016). Studies have not completely defined the mechanism of the block, but the target of the local anesthetic has been proposed to be unmyelinated C fibers / sensory cell bodies within the dorsal root ganglia (Ivanusic 2018).
Since its introduction, hundreds of case reports with a wide spectrum of indications have described ESPB as a useful analgesic adjunct for a wide range of indications (Tsui 2019). The feasibility of ESPBs in spine surgery has likewise been suggested in case reports (Almeida 2019; Chin 2019), case series (Melvin 2018; Singh 2018) and retrospective cohort studies (Ueshima 2019). Each conclude significant opioid-sparing capacity and improved NRS pain scores in patients who receive ESPB for a variety of spine surgery procedures.
More recently, results from 2 RCTs describing outcomes after ESPB for lumbar decompression have been reported. In the first, 60 patients were randomized to receive bilateral ESPB or no intervention (Yayik 2019). NRS scores and tramadol consumption were significantly lower in the first 24 hours after surgery, and the time to requesting opioid analgesia was significantly longer in patients were received ESPB. In the second RCT, postoperative morphine consumption was lower in patients who received ESPB compared to patients who did not receive ESPB (Singh, 2019). NRS scores were lower up to 6 hours after surgery in the ESPB group, and patient satisfaction scores were higher.
These preliminary RCTs are promising; however, both suffer from methodological flaws, including lack of power, inadequate blinding, and incomplete standardization of other intra- and post-operative analgesics.
- Conditions
- Opioid Use, Pain, Postoperative
- Being tested
- Bupivacaine, Dexamethasone, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.
DexamethasoneDrug
Also called Decadron
Dexamethasone is a corticosteroid that reduces inflammation.
SalineOther
Also called sodium chloride
Saline is a mixture of NaCl and water that can be used as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| ESPB with Bupivacaine and Dexamethasone | Active comparator | 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Receives: Drug: Bupivacaine; Drug: Dexamethasone |
| ESPB with saline placebo | Placebo comparator | 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative and Postoperative Opioid Consumption
The total amount of opioid taken during surgery and 24 hours after surgery, measured in morphine milligram equivalent (MME).
Measured: 0-24 hours after surgery (intraoperative + immediately after surgery)
Secondary outcomes (9)
Numeric Rating Scale Pain at Rest
Measured by Numeric Rating Scale (NRS) pain at rest (The minimum value 0 being 'no pain' and the maximum value 10 being 'as bad as you can imagine').
Higher scores means a worse outcome.
Measured: at baseline (holding area), post anesthesia care unit (PACU) (hour 0), hour 6, 12, and 24 hours after surgery
Pain Scores With Physical Therapy
Measured by Numeric Rating Scale (NRS) pain with movement (The minimum value 0 being 'no pain' and the maximum value 10 being 'as bad as you can imagine').
Higher scores means a worse outcome.
Measured: on post-operative physical therapy day 0, 1, and 2
Quality of Recovery
Quality of recovery (QoR) after anesthesia measures the early postoperative health status of patients. QoR15 is the shortened (15 questions) version, each question is scored on the following scales: (Part A: 0 to 10 where 0=none of the time [poor] and 10=all the time [excellent]; Part B: 0 to 10 where 10=none of the time [poor] and 0=all the time [excellent]).
The total recovery score is scored on the following scale excellent= 136-150, good=122-135, moderate=90-121, and poor=0-89.
A lower score means a worst outcome.
Measured: at baseline (holding area), 24 and 72 hours after surgery
Opioid Related Side Effects
The Opioid-Related Symptom Distress Scale (ORSDS) is a 4-point scale (minimum = 0 to maximum = 4) that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness). Measured by 10 symptoms on the following scale: did not have symptom = 0, slight = 1, moderate = 2, severe = 3, very severe = 4.
The total score for each participant was calculated and then the average score for the group was reported.
Measured: at 24 hours after surgery
Blinding Assessment
Measured by bang blinding index (choose between two treatment arms and provide explanation as to why arm was chosen). The blinding index proposed is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding.
The blinding assessment was completed by the participant, research assistant and anesthesiologist (principle investigator).
Measured: at 72 hours after surgery
Time to First Opioid Use Via Intravenous Administration
Time to pressing opioid use via intravenous administration (IV PCA)
Measured: up to 24 hours after surgery
Time to Opioid Consumption Via Oral Administration
Time to pressing opioid use via oral administration (Oral PCA)
Measured: up to 24 hours after surgery
Total Opioid Consumption
Measured in morphine milligram equivalent (MME).
Measured: 0-12 hours after surgery (intraoperative + immediately after surgery)
24 Hours Post-operative Opioid Consumption
The total opioid consumption at 24 hours post-operatively, measured in morphine milligrams equivalent (MME).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start19 Nov 2019
- Primary completion18 Jun 2022
- Study completion18 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid UseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Soffin, MD, PhD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156581
- Sponsor's protocol ID
- 2019-1282
- Acronym
- ESPB-Spine
- Status last verified
- Apr 2024
- First submitted
- 25 Oct 2019
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Certain individual participant data will be available. Individual participant data that underlie the results reported in a future article, after deidentification (text, tables, figures, appendices).
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04156581
- Acronym / sponsor ID
- ESPB-Spine / 2019-1282
- Conditions
- Opioid Use, Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 18 Jun 2022 (actual)
- Study completion
- 18 Jun 2022 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Posted 24 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and analgesic choices to minimize opioid consumption while providing adequate pain control after surgery. Although ERPs for spine surgery are now being described, few pathways include regional analgesia. The Erector Spinae Plane Block (ESPB) may represent a novel opportunity to incorporate regional analgesia into ERPs for spine surgery. To date, there is minimal data to support the utility of ESPB in spine surgery, and this block has not yet been evaluated in complex spine surgery.
This study seeks to see whether ESPB will reduce opioid consumption and pain scores, and improve patient recovery during the first 24 hours after complex spine surgery when included in a comprehensive ERP.
Detailed description
Lumbar spinal fusion with posterior approach is a moderate-severely painful procedure requiring significant postoperative opioid analgesia (Mathiesen, 2013). There are limited opportunities to use multimodal analgesia (MMA) and regional analgesia after spine surgery. For example, non-steroidal anti-inflammatory drugs are not universally provided, due to concerns regarding bleeding and impaired fusion (Sivaganasan, 2017). Likewise, local anesthetic-based techniques may cause motor weakness and sensory changes which interfere with interpretation of the early postoperative neurological examination.
As in other orthopedic subspecialty surgeries, enhanced recovery pathways (ERPs) are now being described in spine surgery (Wang 2017; Soffin 2018; Soffin 2019a; Ali 2019). Published data emphasizes the importance of opioid-sparing MMA to achieve analgesia and minimize opioid-related side effects. However, with the exception of a report from our group, none include regional analgesia or field blocks as an element of care (Soffin 2019b). Further, comparative research regarding the benefits of regional analgesia within standardized ERPs is lacking for other surgical modalities - even within subspecialties where the evidence base to support such trials is more advanced. These deficits highlight an opportunity to demonstrate the unique advantages of regional analgesia over and above that which can be provided by conventional oral and/or intravenous MMA.
Ultrasound-guided erector spinae plane block (ESPB) may represent a novel opportunity to apply regional analgesia to patients undergoing spine surgery. First described in 2016, ESPB provides analgesia by depositing local anesthetic deep to the erector spinae muscles (Forero 2016). Studies have not completely defined the mechanism of the block, but the target of the local anesthetic has been proposed to be unmyelinated C fibers / sensory cell bodies within the dorsal root ganglia (Ivanusic 2018).
Since its introduction, hundreds of case reports with a wide spectrum of indications have described ESPB as a useful analgesic adjunct for a wide range of indications (Tsui 2019). The feasibility of ESPBs in spine surgery has likewise been suggested in case reports (Almeida 2019; Chin 2019), case series (Melvin 2018; Singh 2018) and retrospective cohort studies (Ueshima 2019). Each conclude significant opioid-sparing capacity and improved NRS pain scores in patients who receive ESPB for a variety of spine surgery procedures.
More recently, results from 2 RCTs describing outcomes after ESPB for lumbar decompression have been reported. In the first, 60 patients were randomized to receive bilateral ESPB or no intervention (Yayik 2019). NRS scores and tramadol consumption were significantly lower in the first 24 hours after surgery, and the time to requesting opioid analgesia was significantly longer in patients were received ESPB. In the second RCT, postoperative morphine consumption was lower in patients who received ESPB compared to patients who did not receive ESPB (Singh, 2019). NRS scores were lower up to 6 hours after surgery in the ESPB group, and patient satisfaction scores were higher.
These preliminary RCTs are promising; however, both suffer from methodological flaws, including lack of power, inadequate blinding, and incomplete standardization of other intra- and post-operative analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB with Bupivacaine and Dexamethasone | Active comparator | Drug: Bupivacaine, Drug: Dexamethasone23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. |
| ESPB with saline placebo | Placebo comparator | Other: Saline23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80
- Planned primary complex spine surgery: >2 level- lumbar and/or thoraco-lumbar spine fusion with or without decompression
- Planned stand-alone posterior surgical approach
- Able to follow study protocol
- Able to communicate in English (outcome questionnaires validated in English)
Key exclusion criteria (9 listed)
- Age <18 or >80
- Revision surgery
- BMI > 35
- planned prolonged intubation/intubation overnight on night of surgery
- Unable to communicate in English
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 |
|---|---|---|
| BupivacaineAlso: MarcaineBupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. | Drug | ESPB with Bupivacaine and Dexamethasone |
| DexamethasoneAlso: DecadronDexamethasone is a corticosteroid that reduces inflammation. | Drug | ESPB with Bupivacaine and Dexamethasone |
| SalineAlso: sodium chlorideSaline is a mixture of NaCl and water that can be used as a placebo. | Other | ESPB with saline placebo |
Primary outcome
Intraoperative and Postoperative Opioid Consumption
Time frame: 0-24 hours after surgery (intraoperative + immediately after surgery)
The total amount of opioid taken during surgery and 24 hours after surgery, measured in morphine milligram equivalent (MME).
9 secondary outcomes
Numeric Rating Scale Pain at Rest
Time frame: at baseline (holding area), post anesthesia care unit (PACU) (hour 0), hour 6, 12, and 24 hours after surgery
Pain Scores With Physical Therapy
Time frame: on post-operative physical therapy day 0, 1, and 2
Quality of Recovery
Time frame: at baseline (holding area), 24 and 72 hours after surgery
Opioid Related Side Effects
Time frame: at 24 hours after surgery
Blinding Assessment
Time frame: at 72 hours after surgery
Time to First Opioid Use Via Intravenous Administration
Time frame: up to 24 hours after surgery
Time to Opioid Consumption Via Oral Administration
Time frame: up to 24 hours after surgery
Total Opioid Consumption
Time frame: 0-12 hours after surgery (intraoperative + immediately after surgery)
24 Hours Post-operative Opioid Consumption
Time frame: 24 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Certain individual participant data will be available. Individual participant data that underlie the results reported in a future article, after deidentification (text, tables, figures, appendices).
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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.
Ellen Soffin, MD, PhD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine, Dexamethasone and Saline in people with Opioid Use and Pain, Postoperative, 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 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 27 Dec 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraoperative and Postoperative Opioid Consumption (time frame: 0-24 hours after surgery (intraoperative + immediately after surgery)). 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 27 Dec 2024.