Perioperative Local Anesthesia Block in Spine Surgery

NCT05094427 | Completed

• 1 other identifier: AAAT6085
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Disease; Lumbar Disc Herniation; Lumbar Spinal Stenosis

Keywords

lumbar spine surgery; local anesthesia; local anesthetic block

Outcome Measures

Primary Outcomes (2)

• 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).

  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)

  Within the first 24 hours of surgery

Secondary Outcomes (3)

• Time required to perform block (in minutes)

  Up to 30 minutes from start of DR block placement

• Length of Stay (in hours to days)

  Up to 30 days from completion of surgery during hospital course

• Total number of adverse events

  Up to 24 hours from start of DR block placement

Study Arms (2)

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

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.

Interventions

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).

Also known as: Local anesthetic block

Lumbar spine surgery with preoperative fluoroscopically-guided DR block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Spinal Diseases; Intervertebral Disc Displacement; Spinal Stenosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoper E. Mandigo, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 26, 2021
• Study Start: March 10, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

US (1)