Perioperative Local Anesthesia Block in Spine Surgery

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05094427
• Other study ID #: AAAT6085
• Status: Completed
• Start date: March 10, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Spinal Diseases
• Spinal Stenosis

Intervention

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).

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time required to perform block (in minutes)	Among patients who received DR block, total procedure time required to perform the block, intraoperatively.	Up to 30 minutes from start of DR block placement
Secondary	Length of Stay (in hours to days)	Total time in hospital from end of surgery to discharge	Up to 30 days from completion of surgery during hospital course
Secondary	Total number of adverse events	Adverse cardiovascular events (hypotension, arrhythmia, cardiac arrest), adverse neurological events (unexpected neurological deficit, seizures, changes in intraoperative neuromonitoring)	Up to 24 hours from start of DR block placement