Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery (ESPB-Spine)
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|ClinicalTrials.gov Identifier: NCT04156581|
Recruitment Status : Suspended (response to COVID-19)
First Posted : November 7, 2019
Last Update Posted : April 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Pain, Postoperative||Drug: Bupivacaine Drug: Dexamethasone Other: Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery: A Randomized Controlled Trial|
|Actual Study Start Date :||October 14, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Active Comparator: 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 is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.
Dexamethasone is a corticosteroid that reduces inflammation.
Placebo Comparator: 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 is a mixture of NaCl and water that can be used as a placebo.
- Total Opioid Consumption [ Time Frame: 0-24 hours after surgery (intraoperative + immediately after surgery) ]Measured in mean oral morphine equivalents (OME)
- Pain Scores at Rest [ Time Frame: at baseline (holding area), PACU (hour 0), hour 6, 12, and 24 hours after surgery ]Measured by Numeric Rating Scale (NRS) pain at rest (0 being no pain and 10 being as bad as you can imagine)
- Pain Scores with Physical Therapy [ Time Frame: on post-operative physical therapy day 0, 1, and 2 ]Measured by Numeric Rating Scale (NRS) pain with movement (0 being no pain and 10 being as bad as you can imagine)
- Quality of Recovery: QoR15 [ Time Frame: at baseline (holding area), 24 and 72 hours after surgery ]Measured by QoR15 (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])
- Opioid Related Side Effects [ Time Frame: at 24 hours after surgery ]Measured by 10 symptom ORSDS (symptom frequency: rarely to almost constantly; symptom severity: slight to very severe; symptom distress: not at all to very much)
- Blinding Assessment [ Time Frame: at 72 hours after surgery ]Measured by bang blinding index (choose between two treatment arms and provide explanation as to why arm was chosen)
- Time to Opioid Use [ Time Frame: up to 24 hours after surgery ]Time to pressing IV PCA and to requesting first oral opioid
- Total Opioid Consumption [ Time Frame: 0-12 hours after surgery (intraoperative + immediately after surgery) ]Measured in mean oral morphine equivalents (OME)
- Total Opioid Consumption [ Time Frame: 13-24 hours after surgery ]Measured in mean oral morphine equivalents (OME)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156581
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Ellen Soffin, MD PhD||Hospital for Special Surgery, New York|