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OpenTrials
Completed

NCT Number: NCT05094427

Perioperative Local Anesthesia Block in Spine Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Preoperative fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon

Procedure

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

Primary outcomes

  1. 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).

  2. 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)

Secondary outcomes

  1. Time required to perform block (in minutes)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Perioperative Local Anesthesia Block in Spine Surgery: A Retrospective Chart Review

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2021
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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