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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05494125
• Other study ID #: 2021-1815
• Status: Terminated
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: March 18, 2024

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 18, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain
• Spine Surgery

Intervention

Other:
• Ropivacaine
Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters
• Placebo
Patients will receive a continuous infusion of saline solution through bilateral ESP catheters

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of use and dose of opioid-iv-pca (if required)	Measured in morphine equivalents daily	First 72 hours after surgery
Secondary	Post-operative opioid consumption	Measured in morphine equivalents daily	From PACU arrival to 72 hours post surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Total dose of ropivacaine delivered	Measured in mg/kg/hr	First 48 hours post surgery
Secondary	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
Secondary	Length of hospital stay	Measured in days after surgery	From PACU arrival to hospital discharge, up to 2 weeks
Secondary	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
Secondary	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