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

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status

Terminated

Conditions

Spine Surgery
Post Operative Pain

Treatments

Other: Ropivacaine
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05494125
2021-1815

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10 participants in 2 patient groups, including a placebo group

ESP Catheters with Ropivacaine 0.2%
Experimental group
Treatment:
Other: Ropivacaine
ESP Catheters with Saline Solution
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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