Perioperative Local Anesthesia Block in Spine Surgery

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05094427
Study type	Observational
Source	Columbia University
Contact
Status	Completed
Phase
Start date	March 10, 2021
Completion date	March 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04795284` - Biomechanical Parameters of Gait in Patients With Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
Recruiting	`NCT04066296` - Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine	Phase 2
Active, not recruiting	`NCT05114135` - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)	N/A
Recruiting	`NCT06075862` - Balance Amongst Patients With Lumbar Spinal Stenosis
Recruiting	`NCT06057428` - Activity Levels Amongst Patients With Lumbar Spinal Stenosis
Recruiting	`NCT05527145` - Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial	N/A
Recruiting	`NCT01902979` - The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial	N/A
Completed	`NCT00749073` - The Vertos MILD™ Preliminary Patient Evaluation Study	N/A
Completed	`NCT00527527` - Chiropractic Dosage for Lumbar Stenosis	Phase 2
Completed	`NCT00405691` - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis	Phase 3
Completed	`NCT03194607` - Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
Recruiting	`NCT06034405` - Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Completed	`NCT06079580` - Patients With Lumbar Spinal Stenosis With Balance Disorder
Recruiting	`NCT05523388` - Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis
Completed	`NCT04587401` - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure	N/A
Completed	`NCT04563793` - Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Suspended	`NCT03381677` - Pedicle Osteotomy for Stenosis Trial	N/A
Completed	`NCT02258672` - Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis	N/A
Completed	`NCT02260401` - Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis	N/A
Completed	`NCT01994512` - Swedish Spinal Stenosis Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.