Perioperative Local Anesthesia Block in Spine Surgery

Sponsor
Columbia University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05094427
Collaborator
(none)
200
1
14.7
13.6

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Preoperative fluoroscopically-guided dorsal ramus 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

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Perioperative Local Anesthesia Block in Spine Surgery: A Retrospective Chart Review
Actual Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: Preoperative fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon
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).
Other Names:
  • Local anesthetic block
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. First visual analog scale (VAS) pain score in the post-anesthesia care unit (PACU) [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).

    2. Total PACU opioid requirements [Within the first 24 hours of surgery]

      Total opioids received within the PACU prior to discharge home or transfer to floor (oral morphine equivalents)

    Secondary Outcome Measures

    1. Time required to perform block (in minutes) [Up to 30 minutes from start of DR block placement]

      Among patients who received DR block, total procedure time required to perform the block, intraoperatively.

    2. Length of Stay (in hours to days) [Up to 30 days from completion of surgery during hospital course]

      Total time in hospital from end of surgery to discharge

    3. Total number of adverse events [Up to 24 hours from start of DR block placement]

      Adverse cardiovascular events (hypotension, arrhythmia, cardiac arrest), adverse neurological events (unexpected neurological deficit, seizures, changes in intraoperative neuromonitoring)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • 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)

    Exclusion Criteria:
    • 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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Irving Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: Christoper E. Mandigo, MD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Columbia University
    ClinicalTrials.gov Identifier:
    NCT05094427
    Other Study ID Numbers:
    • AAAT6085
    First Posted:
    Oct 26, 2021
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Columbia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 21, 2022