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

Effects of Continuous Erector Spinae Plane Blocks on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery: A Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Terminated
• Conditions: Post Operative Pain; Spine Surgery
• Intervention / Treatment: Other: Ropivacaine; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP Catheters with Ropivacaine 0.2%	Other: Ropivacaine; Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters
Placebo Comparator: ESP Catheters with Saline Solution	Other: Placebo; Patients will receive a continuous infusion of saline solution through bilateral ESP catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of use and dose of opioid-iv-pca (if required)	Measured in morphine equivalents daily	First 72 hours after surgery
Post-operative opioid consumption	Measured in morphine equivalents daily	From PACU arrival to 72 hours post surgery
Numeric rating scale (NRS) pain scores: every 8 hours	Scale of 0-10, 0 being no pain, 10 being the worst pain possible	Between PACU and 72 hours post surgery
Quality of Recovery 15 (QoR15) scores	The Quality of Recovery 15 (QoR15) is a 15-item questionnaire which assesses five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. It has a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).	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	Measured in days after placement	First 48 hours post surgery
Total dose of ropivacaine delivered	Measured in mg/kg/hr	First 48 hours post surgery
Opioid-related side effects (nausea, vomiting, anti-emetic medication administration, constipation, sedation, administration of naloxone)	If the patient ever had any of the events	First 48 hours post surgery
Length of hospital stay	Measured in days after surgery	From PACU arrival to hospital discharge, up to 2 weeks
Patient satisfaction scale with pain management and ESP catheters	Patient satisfaction will be assessed using a 0 to 10 scale (0 being not satisfied to 10 being totally satisfied)	First 72 hours, 14 days, and 42 days post surgery
Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery	Measured with a 7-item questionnaire to assess chronic pain and opioid use	3 and 6 month post surgery

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): March 18, 2024

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2021-1815

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No