Perioperative Local Anesthesia Block in Spine Surgery

NCT ID: NCT05094427

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 232 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2022-03-31

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.

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.

Conditions

Lumbar Spine Disease; Lumbar Disc Herniation; Lumbar Spinal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

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

Intervention Type: 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).

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.

No interventions assigned to this group

Interventions

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).

Intervention Type: PROCEDURE

Other Intervention Names

Local anesthetic block

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoper E. Mandigo, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAT6085

Identifier Type: -

Identifier Source: org_study_id