Opioid Use, Pain, Postoperative
Conditions
Brief 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. 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.
Interventions
DRUGBupivacaine
Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.
DRUGDexamethasone
Dexamethasone is a corticosteroid that reduces inflammation.
OTHERSaline
Saline is a mixture of NaCl and water that can be used as a placebo.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative and Postoperative Opioid Consumption | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores With Physical Therapy | on post-operative physical therapy day 0, 1, and 2 | 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. |
| Quality of Recovery | at baseline (holding area), 24 and 72 hours after surgery | 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. |
| Opioid Related Side Effects | at 24 hours after surgery | 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. |
| Blinding Assessment | at 72 hours after surgery | 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). |
| Numeric Rating Scale Pain at Rest | at baseline (holding area), post anesthesia care unit (PACU) (hour 0), hour 6, 12, and 24 hours after surgery | 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. |
| Time to Opioid Consumption Via Oral Administration | up to 24 hours after surgery | Time to pressing opioid use via oral administration (Oral PCA) |
| Total Opioid Consumption | 0-12 hours after surgery (intraoperative + immediately after surgery) | Measured in morphine milligram equivalent (MME). |
| 24 Hours Post-operative Opioid Consumption | 24 hours after surgery | The total opioid consumption at 24 hours post-operatively, measured in morphine milligrams equivalent (MME). |
| Time to First Opioid Use Via Intravenous Administration | up to 24 hours after surgery | Time to pressing opioid use via intravenous administration (IV PCA) |
Countries
United States
Participant flow
Recruitment details
All recruitment conducted at the Hospital for Special Surgery between 11/2019 and 6/2022.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Total | ESPB With Saline Placebo | ESPB With Bupivacaine and Dexamethasone |
|---|---|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 17.1 | 57.26 years STANDARD_DEVIATION 16.48 | 59.13 years STANDARD_DEVIATION 18.02 |
| Body Mass Index | 24.93 kg/m^2 STANDARD_DEVIATION 3.95 | 24.49 kg/m^2 STANDARD_DEVIATION 3.55 | 25.36 kg/m^2 STANDARD_DEVIATION 4.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 20 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 1.65 meters STANDARD_DEVIATION 0.12 | 1.64 meters STANDARD_DEVIATION 0.1 | 1.66 meters STANDARD_DEVIATION 0.014 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 42 Participants | 20 Participants | 22 Participants |
| Sex: Female, Male Female | 28 Participants | 16 Participants | 12 Participants |
| Sex: Female, Male Male | 18 Participants | 7 Participants | 11 Participants |
| Weight | 68.35 kg STANDARD_DEVIATION 14.69 | 66.23 kg STANDARD_DEVIATION 12.88 | 70.46 kg STANDARD_DEVIATION 16.31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 1 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
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).
Time frame: 0-24 hours after surgery (intraoperative + immediately after surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Intraoperative and Postoperative Opioid Consumption | 191 MME/day | Standard Deviation 195.2 |
| ESPB With Saline Placebo | Intraoperative and Postoperative Opioid Consumption | 139.4 MME/day | Standard Deviation 70.5 |
Secondary
24 Hours Post-operative Opioid Consumption
The total opioid consumption at 24 hours post-operatively, measured in morphine milligrams equivalent (MME).
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | 24 Hours Post-operative Opioid Consumption | 42.9 MME/day | Standard Deviation 31.1 |
| ESPB With Saline Placebo | 24 Hours Post-operative Opioid Consumption | 47.6 MME/day | Standard Deviation 33.2 |
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).
Time frame: at 72 hours after surgery
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Blinding Assessment | Bang Blinding Index (participants' response) | .045 score on a scale |
| ESPB With Bupivacaine and Dexamethasone | Blinding Assessment | Bang Blinding Index (research assistant's response) | 0.318 score on a scale |
| ESPB With Bupivacaine and Dexamethasone | Blinding Assessment | Bang Blinding Index (anesthesiologist's response) | 0.381 score on a scale |
| ESPB With Saline Placebo | Blinding Assessment | Bang Blinding Index (participants' response) | -0.048 score on a scale |
| ESPB With Saline Placebo | Blinding Assessment | Bang Blinding Index (research assistant's response) | -0.045 score on a scale |
| ESPB With Saline Placebo | Blinding Assessment | Bang Blinding Index (anesthesiologist's response) | -0.429 score on a scale |
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.
Time frame: at baseline (holding area), post anesthesia care unit (PACU) (hour 0), hour 6, 12, and 24 hours after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at baseline | 2.74 score on a scale | Standard Deviation 2.56 |
| ESPB With Bupivacaine and Dexamethasone | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at 12 hours | 3.19 score on a scale | Standard Deviation 2.1 |
| ESPB With Bupivacaine and Dexamethasone | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at 6 hours | 3.33 score on a scale | Standard Deviation 2.35 |
| ESPB With Bupivacaine and Dexamethasone | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at 24 hours | 3.86 score on a scale | Standard Deviation 2.1 |
| ESPB With Bupivacaine and Dexamethasone | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at PACU (0 hours) | 3.56 score on a scale | Standard Deviation 3.93 |
| ESPB With Saline Placebo | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at 24 hours | 4.05 score on a scale | Standard Deviation 1.96 |
| ESPB With Saline Placebo | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at baseline | 3.04 score on a scale | Standard Deviation 2.2 |
| ESPB With Saline Placebo | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at PACU (0 hours) | 4.15 score on a scale | Standard Deviation 4.07 |
| ESPB With Saline Placebo | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at 6 hours | 3.9 score on a scale | Standard Deviation 2.49 |
| ESPB With Saline Placebo | Numeric Rating Scale Pain at Rest | Pain Scores at Rest at 12 hours | 3.87 score on a scale | Standard Deviation 2.53 |
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.
Time frame: at 24 hours after surgery
Population: The Number of Participants Analyzed differs from the number of participants assigned to each arm due to lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | 2.56 score on a scale | Standard Deviation 0.67 |
| ESPB With Saline Placebo | Opioid Related Side Effects | 2.24 score on a scale | Standard Deviation 0.65 |
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.
Time frame: on post-operative physical therapy day 0, 1, and 2
Population: The Number of Participants Analyzed differs from the number of participants assigned to each arm due to lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Pain Scores With Physical Therapy | Pain with movement (physical therapy) at POD 0 | 3 score on a scale | Standard Deviation 1.41 |
| ESPB With Bupivacaine and Dexamethasone | Pain Scores With Physical Therapy | Pain with movement (physical therapy) at POD 1 | 4.29 score on a scale | Standard Deviation 2.8 |
| ESPB With Bupivacaine and Dexamethasone | Pain Scores With Physical Therapy | Pain with movement (physical therapy) at POD 2 | 4.94 score on a scale | Standard Deviation 2.95 |
| ESPB With Saline Placebo | Pain Scores With Physical Therapy | Pain with movement (physical therapy) at POD 0 | 2 score on a scale | Standard Deviation 2.45 |
| ESPB With Saline Placebo | Pain Scores With Physical Therapy | Pain with movement (physical therapy) at POD 1 | 3.9 score on a scale | Standard Deviation 2.29 |
| ESPB With Saline Placebo | Pain Scores With Physical Therapy | Pain with movement (physical therapy) at POD 2 | 3.53 score on a scale | Standard Deviation 2.85 |
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.
Time frame: at baseline (holding area), 24 and 72 hours after surgery
Population: The Number of Participants Analyzed differs from the number of participants assigned to each arm due to lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Quality of Recovery | Quality of recovery (QoR) at preop | 101.36 score on a scale | Standard Deviation 10.62 |
| ESPB With Bupivacaine and Dexamethasone | Quality of Recovery | Quality of recovery (QoR) at 24 hours | 69.85 score on a scale | Standard Deviation 14.75 |
| ESPB With Bupivacaine and Dexamethasone | Quality of Recovery | Quality of recovery (QoR) at 72 hours | 79.67 score on a scale | Standard Deviation 11.89 |
| ESPB With Saline Placebo | Quality of Recovery | Quality of recovery (QoR) at preop | 99.45 score on a scale | Standard Deviation 10.53 |
| ESPB With Saline Placebo | Quality of Recovery | Quality of recovery (QoR) at 24 hours | 74.73 score on a scale | Standard Deviation 10.22 |
| ESPB With Saline Placebo | Quality of Recovery | Quality of recovery (QoR) at 72 hours | 79.82 score on a scale | Standard Deviation 12.53 |
Secondary
Time to First Opioid Use Via Intravenous Administration
Time to pressing opioid use via intravenous administration (IV PCA)
Time frame: up to 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Time to First Opioid Use Via Intravenous Administration | 237.73 minutes | Standard Deviation 185.91 |
| ESPB With Saline Placebo | Time to First Opioid Use Via Intravenous Administration | 286.23 minutes | Standard Deviation 458.77 |
Secondary
Time to Opioid Consumption Via Oral Administration
Time to pressing opioid use via oral administration (Oral PCA)
Time frame: up to 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Time to Opioid Consumption Via Oral Administration | 254.62 minutes | Standard Deviation 360.87 |
| ESPB With Saline Placebo | Time to Opioid Consumption Via Oral Administration | 141.09 minutes | Standard Deviation 271.87 |
Secondary
Total Opioid Consumption
Measured in morphine milligram equivalent (MME).
Time frame: 0-12 hours after surgery (intraoperative + immediately after surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Total Opioid Consumption | 21.83 MME/day | Standard Deviation 15.42 |
| ESPB With Saline Placebo | Total Opioid Consumption | 25.48 MME/day | Standard Deviation 18.37 |