Lumbar Spine DiseaseNCT05094427
Perioperative Local Anesthesia Block in Spine Surgery
An observational study of Lumbar Spine Disease and Lumbar Disc Herniation, run by Columbia University at 1 site in United States.
Trial summary
The purpose of the this study to evaluate the feasibility, safety, and efficacy of a fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon prior to lumbosacral surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spine Disease, Lumbar Disc Herniation, Lumbar Spinal Stenosis
- What is being tested?
- Preoperative fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 31 Mar 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The population consists of a convenience sample of patients undergoing lumbar spine surgery at a tertiary care academic medical center and an associated specialized spine hospital.
Who may be able to join
- Patients aged 18 years and older
- Patients undergoing lumbar spine surgery at any spinal level from L1 to sacrum (including decompression, discectomy, posterior fusion, interbody fusion, wound revision or washout, intradural tumor resection, treatment of vascular spinal lesion, tethered cord release, repair of cerebrospinal fluid (CSF) leak, hardware removal)
Who cannot join
- Patients undergoing surgery that includes thoracic levels
- Patients from whom pain scores could not be elicited in the immediate postoperative period due to mental status (e.g. prolonged intubation requirement, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Perioperative Local Anesthesia Block in Spine Surgery: A Retrospective Chart Review
The purpose of the this study to evaluate the feasibility, safety, and efficacy of a fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon prior to lumbosacral surgery. The study will consist of a retrospective analysis of a cohort of patients who underwent lumbosacral surgery patients between June 2018 and March 2021 with or without a preoperative fluoroscopically-guided dorsal ramus (DR) block placed by the operative neurosurgeon.
Read the detailed description
Spine surgery poses unique challenges in postoperative pain management. Local anesthetic blocks, namely the erector spinae plane and thoracolumbar interfacial plane blocks, placed by anesthesia under ultrasound guidance have been shown to reduce postoperative pain after spinal surgery and decrease perioperative opioid requirements by as much as 50%. Nonetheless these procedures are not routinely performed, likely due to logistical hurdles and lack of widespread knowledge of the procedure by anesthesiologists. A preoperative dorsal ramus block performed by the operative neurosurgeon under fluoroscopy shows promise as an alternative approach to perioperative pain control. The objective of this retrospective observational study is to evaluate the feasibility, safety, and efficacy of a dorsal ramus block block performed by a neurosurgeon under x-ray guidance prior to lumbar surgery. The study will include a cohort of patients who have undergone lumbar spine surgery with or without the x-ray guided dorsal ramus block. A retrospective chart review of these patients will be performed to assess for postoperative pain control, postoperative opioid requirements, time to block completion, length of stay, and adverse events. Descriptive and comparative statistics will be performed. No new data will be gathered from the subjects beyond pre-existing data within the medical record, and no new procedures will be performed as part of the study. If the current study suggests that a dorsal ramus block performed by the operative neurosurgeon is feasible, safe, and effective, it will serve as a foundation for a randomized clinical trial of such a block among patients undergoing lumbar surgery.
- Being tested
- Preoperative fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon
- Keywords
- lumbar spine surgery, local anesthesia, local anesthetic block
- Medical subject headings
- Spinal Diseases, Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeonProcedure or surgery
Also called Local anesthetic block
Patients received bupivicaine injections delivered via 22-gauge spinal needle to the junction of the facet and transverse process or ala at multiple spinal levels (2.5-5 cc per injection of 0.25% or 0.5% bupivacaine).
| Study group | Role | What they receive |
|---|---|---|
| Lumbar spine surgery with preoperative fluoroscopically-guided DR block | Patients who have undergone lumbar spine surgery with a fluoroscopically-guided DR block placed by the operative neurosurgeon prior to surgery. These patients subsequently received standard of care general anesthesia and standard multimodality postoperative pain control. Receives: Procedure: Preoperative fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon | |
| Lumbar spine surgery without preoperative fluoroscopically-guided DR block | Patients who have undergone lumbar spine surgery without placement of a fluoroscopically-guided DR block. These patients received standard of care general anesthesia and standard multimodality postoperative pain control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
First visual analog scale (VAS) pain score in the post-anesthesia care unit (PACU)
The first VAS pain score recorded within the PACU on a 0-10 scale, with 0 indicating no pain (better outcome) and 10 indicating more pain (worse outcome).
Measured: Within the first 24 hours of surgery
Total PACU opioid requirements
Total opioids received within the PACU prior to discharge home or transfer to floor (oral morphine equivalents)
Measured: Within the first 24 hours of surgery
Secondary outcomes (3)
Time required to perform block (in minutes)
Among patients who received DR block, total procedure time required to perform the block, intraoperatively.
Measured: Up to 30 minutes from start of DR block placement
Length of Stay (in hours to days)
Total time in hospital from end of surgery to discharge
Measured: Up to 30 days from completion of surgery during hospital course
Total number of adverse events
Adverse cardiovascular events (hypotension, arrhythmia, cardiac arrest), adverse neurological events (unexpected neurological deficit, seizures, changes in intraoperative neuromonitoring)
Measured: Up to 24 hours from start of DR block placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start10 Mar 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoper E. Mandigo, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094427
- Sponsor's protocol ID
- AAAT6085
- Status last verified
- Sep 2022
- First submitted
- 14 Oct 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Local Anesthesia Block in Spine Surgery: A Retrospective Chart Review
- ClinicalTrials.gov ID
- NCT05094427
- Acronym / sponsor ID
- AAAT6085
- Keywords
- lumbar spine surgery, local anesthesia, local anesthetic block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 26 Oct 2021 (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.
The purpose of the this study to evaluate the feasibility, safety, and efficacy of a fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon prior to lumbosacral surgery. The study will consist of a retrospective analysis of a cohort of patients who underwent lumbosacral surgery patients between June 2018 and March 2021 with or without a preoperative fluoroscopically-guided dorsal ramus (DR) block placed by the operative neurosurgeon.
Detailed description
Spine surgery poses unique challenges in postoperative pain management. Local anesthetic blocks, namely the erector spinae plane and thoracolumbar interfacial plane blocks, placed by anesthesia under ultrasound guidance have been shown to reduce postoperative pain after spinal surgery and decrease perioperative opioid requirements by as much as 50%. Nonetheless these procedures are not routinely performed, likely due to logistical hurdles and lack of widespread knowledge of the procedure by anesthesiologists. A preoperative dorsal ramus block performed by the operative neurosurgeon under fluoroscopy shows promise as an alternative approach to perioperative pain control. The objective of this retrospective observational study is to evaluate the feasibility, safety, and efficacy of a dorsal ramus block block performed by a neurosurgeon under x-ray guidance prior to lumbar surgery. The study will include a cohort of patients who have undergone lumbar spine surgery with or without the x-ray guided dorsal ramus block. A retrospective chart review of these patients will be performed to assess for postoperative pain control, postoperative opioid requirements, time to block completion, length of stay, and adverse events. Descriptive and comparative statistics will be performed. No new data will be gathered from the subjects beyond pre-existing data within the medical record, and no new procedures will be performed as part of the study. If the current study suggests that a dorsal ramus block performed by the operative neurosurgeon is feasible, safe, and effective, it will serve as a foundation for a randomized clinical trial of such a block among patients undergoing lumbar surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar spine surgery with preoperative fluoroscopically-guided DR block | – | Procedure: Preoperative fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeonPatients who have undergone lumbar spine surgery with a fluoroscopically-guided DR block placed by the operative neurosurgeon prior to surgery. These patients subsequently received standard of care general anesthesia and standard multimodality postoperative pain control. |
| Lumbar spine surgery without preoperative fluoroscopically-guided DR block | – | –Patients who have undergone lumbar spine surgery without placement of a fluoroscopically-guided DR block. These patients received standard of care general anesthesia and standard multimodality postoperative pain control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The population consists of a convenience sample of patients undergoing lumbar spine surgery at a tertiary care academic medical center and an associated specialized spine hospital.
Key inclusion criteria (2 listed)
- Patients aged 18 years and older
- Patients undergoing lumbar spine surgery at any spinal level from L1 to sacrum (including decompression, discectomy, posterior fusion, interbody fusion, wound revision or washout, intradural tumor resection, treatment of vascular spinal lesion, tethered cord release, repair of cerebrospinal fluid (CSF) leak, hardware removal)
Key exclusion criteria (2 listed)
- Patients undergoing surgery that includes thoracic levels
- Patients from whom pain scores could not be elicited in the immediate postoperative period due to mental status (e.g. prolonged intubation requirement, etc.)
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 |
|---|---|---|
| Preoperative fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeonAlso: Local anesthetic blockPatients received bupivicaine injections delivered via 22-gauge spinal needle to the junction of the facet and transverse process or ala at multiple spinal levels (2.5-5 cc per injection of 0.25% or 0.5% bupivacaine). | Procedure or surgery | Lumbar spine surgery with preoperative fluoroscopically-guided DR block |
Primary outcome
First visual analog scale (VAS) pain score in the post-anesthesia care unit (PACU)
Time frame: Within the first 24 hours of surgery
The first VAS pain score recorded within the PACU on a 0-10 scale, with 0 indicating no pain (better outcome) and 10 indicating more pain (worse outcome).
Total PACU opioid requirements
Time frame: Within the first 24 hours of surgery
Total opioids received within the PACU prior to discharge home or transfer to floor (oral morphine equivalents)
3 secondary outcomes
Time required to perform block (in minutes)
Time frame: Up to 30 minutes from start of DR block placement
Length of Stay (in hours to days)
Time frame: Up to 30 days from completion of surgery during hospital course
Total number of adverse events
Time frame: Up to 24 hours from start of DR block placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Christoper E. Mandigo, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Disease and Lumbar Disc Herniation, run by Columbia University 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 2 inclusion and 2 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 13 Sep 2022. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
First visual analog scale (VAS) pain score in the post-anesthesia care unit (PACU) (time frame: Within the first 24 hours of surgery). The study lists 2 primary outcomes in all. 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 13 Sep 2022.