Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative and Postoperative Opioid Consumption | The total amount of opioid taken during surgery and 24 hours after surgery, measured in morphine milligram equivalent (MME). | 0-24 hours after surgery (intraoperative + immediately after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline (holding area), post anesthesia care unit (PACU) (hour 0), hour 6, 12, and 24 hours after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ellen Soffin, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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).
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.
Not provided
Not provided
All recruitment conducted at the Hospital for Special Surgery between 11/2019 and 6/2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ESPB With Bupivacaine and Dexamethasone | 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. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation. |
| FG001 | ESPB With Saline Placebo | 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. Saline: Saline is a mixture of NaCl and water that can be used as a placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ESPB With Bupivacaine and Dexamethasone | 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. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The age of the participant at the time of enrollment. Measured in years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative and Postoperative Opioid Consumption | The total amount of opioid taken during surgery and 24 hours after surgery, measured in morphine milligram equivalent (MME). | Posted | Mean | Standard Deviation | MME/day | 0-24 hours after surgery (intraoperative + immediately after surgery) |
|
Adverse events data will be collected over the course of study enrollment and research activities. For this study, adverse events for each participant were assessed from the day of enrollment to the last day of study follow up, post-operative day 3.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ESPB With Bupivacaine and Dexamethasone | 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. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-operative tachycardia and hypoxia | General disorders | Non-systematic Assessment | The participant had new-onset tachycardia and hypoxia after surgery, and a CT scan showed that they had segmental and subsegmental pulmonary emboli on both sides in various lobes. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Justas Lauzadis | Hospital for Special Surgery | 212-774-2946 | lauzadisj@hss.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2024 | Jan 3, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dexamethasone | Drug | Dexamethasone is a corticosteroid that reduces inflammation. |
|
|
| Saline | Other | Saline is a mixture of NaCl and water that can be used as a placebo. |
|
|
| 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. |
| 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. | 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. | 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). | at 72 hours after surgery |
| Time to First Opioid Use Via Intravenous Administration | Time to pressing opioid use via intravenous administration (IV PCA) | up to 24 hours after surgery |
| Time to Opioid Consumption Via Oral Administration | Time to pressing opioid use via oral administration (Oral PCA) | up to 24 hours after surgery |
| Total Opioid Consumption | Measured in morphine milligram equivalent (MME). | 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). | 24 hours after surgery |
| BG001 | ESPB With Saline Placebo | 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. Saline: Saline is a mixture of NaCl and water that can be used as a placebo. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The participant's sex as reported by the patient. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | The self-reported race of the participant. | Count of Participants | Participants |
|
| Body Mass Index | The participants' body mass index at the time of study enrollment. | Mean | Standard Deviation | kg/m^2 |
|
| Weight | The participants' weight at the time of study enrollment. | Mean | Standard Deviation | kg |
|
| Height | The participants' height at the time of study enrollment. | Mean | Standard Deviation | meters |
|
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. Saline: Saline is a mixture of NaCl and water that can be used as a placebo. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | at baseline (holding area), post anesthesia care unit (PACU) (hour 0), hour 6, 12, and 24 hours after surgery |
|
|
|
| Secondary | 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. | The Number of Participants Analyzed differs from the number of participants assigned to each arm due to lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | on post-operative physical therapy day 0, 1, and 2 |
|
|
|
| Secondary | 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. | The Number of Participants Analyzed differs from the number of participants assigned to each arm due to lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | at baseline (holding area), 24 and 72 hours after surgery |
|
|
|
| Secondary | 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. | The Number of Participants Analyzed differs from the number of participants assigned to each arm due to lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | at 24 hours after surgery |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | at 72 hours after surgery |
|
|
|
| Secondary | Time to First Opioid Use Via Intravenous Administration | Time to pressing opioid use via intravenous administration (IV PCA) | Posted | Mean | Standard Deviation | minutes | up to 24 hours after surgery |
|
|
|
| Secondary | Time to Opioid Consumption Via Oral Administration | Time to pressing opioid use via oral administration (Oral PCA) | Posted | Mean | Standard Deviation | minutes | up to 24 hours after surgery |
|
|
|
| Secondary | Total Opioid Consumption | Measured in morphine milligram equivalent (MME). | Posted | Mean | Standard Deviation | MME/day | 0-12 hours after surgery (intraoperative + immediately after surgery) |
|
|
|
| Secondary | 24 Hours Post-operative Opioid Consumption | The total opioid consumption at 24 hours post-operatively, measured in morphine milligrams equivalent (MME). | Posted | Mean | Standard Deviation | MME/day | 24 hours after surgery |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | ESPB With Saline Placebo | 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. Saline: Saline is a mixture of NaCl and water that can be used as a placebo. | 0 | 23 | 0 | 23 | 1 | 23 |
|
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Pain Scores at Rest at 6 hours |
|
| Pain Scores at Rest at 12 hours |
|
| Pain Scores at Rest at 24 hours |
|
| Pain with movement (physical therapy) at POD 2 |
|
| Quality of recovery (QoR) at 72 hours |
|
| Bang Blinding Index (anesthesiologist's response) |
|