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

NCT05494125 | Terminated

• 1 other identifier: 2021-1815
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain; Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)

  First 72 hours after surgery

Secondary Outcomes (10)

• Duration of use and dose of opioid-iv-pca (if required)

  First 72 hours after surgery

• Post-operative opioid consumption

  From PACU arrival to 72 hours post surgery

• Numeric rating scale (NRS) pain scores: every 8 hours

  Between PACU and 72 hours post surgery

• Quality of Recovery 15 (QoR15) scores

  Pre-operative, holding area/day of surgery, 24 hours, 48 hours, 14 days and 42 days post surgery

• Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement

  First 48 hours post surgery

Study Arms (2)

ESP Catheters with Ropivacaine 0.2%

EXPERIMENTAL

Other: Ropivacaine

ESP Catheters with Saline Solution

PLACEBO COMPARATOR

Other: Placebo

Interventions

Ropivacaine OTHER

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

ESP Catheters with Ropivacaine 0.2%

Placebo OTHER

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

ESP Catheters with Saline Solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

• Amoroso K, Hughes AP, Sama AA, Cammisa FP, Shue J, Soffin EM. Continuous erector spinae plane catheters leading to unwanted neuraxial spread after spinal fusion surgery: a report of two cases from a terminated prospective randomized clinical trial. Reg Anesth Pain Med. 2023 Sep;48(9):478-481. doi: 10.1136/rapm-2023-104587. Epub 2023 May 16.

  PMID: 37192785 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: August 9, 2022
• Study Start: September 14, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 18, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

US (1)