Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2024-03-18

Brief Summary

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Single-shot erector spinae plane (ESP) blocks (ESPB) are emerging as an intervention to improve pain and minimize opioid consumption after lumbar spine surgery. Although promising, there is minimal evidence to support routine use, and widespread clinical adoption may be limited to centers with advanced regional anesthesia resources and expertise. Continuous ESP catheter techniques may solve these problems but are associated with challenges of their own. This trial will investigate the role of adding surgeon-placed, continuous ESP catheters to single-shot ESPBs for patients undergoing multilevel spine surgery. It will assess whether adding ESP catheters with ropivacaine infusion for 48 hours after surgery offers opioid-minimizing analgesia and improves patient quality of recovery, compared to ESP catheters with saline/placebo infusion for 48 hours.

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Detailed Description

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Conditions

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Post Operative Pain Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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ESP Catheters with Ropivacaine 0.2%

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type OTHER

Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters

ESP Catheters with Saline Solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Patients will receive a continuous infusion of saline solution through bilateral ESP catheters

Interventions

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Ropivacaine

Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters

Intervention Type OTHER

Placebo

Patients will receive a continuous infusion of saline solution through bilateral ESP catheters

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-80
* Presenting for elective multilevel (\>2 spinal levels) spinal fusion
* Lumbar, thoracic, and thoracolumbar procedures included
* Posterior surgical approach
* Willing and able to follow the study protocol
* Able to provide informed consent

Exclusion Criteria

* Opioid tolerance (more than 60 morphine milliequivalents daily for more than 3 months)
* Daily gabapentin/pregabalin use for longer than 3 months
* Prior spine surgery at the index level
* Allergy or contraindication (including renal, liver disease) to included study medications
* Patient refusal

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes