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ESP Block with Ropivacaine for Postoperative Pain

N/A
Recruiting
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Posterior surgical approach
Lumbar, thoracic, and thoracolumbar procedures included
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 month post surgery
Awards & highlights

Study Summary

This trial will investigate whether adding a continuous infusion of a local anesthetic to a single-shot erector spinae plane block (ESPB) provides better pain relief and fewer side effects than a placebo infusion for people undergoing multilevel spine surgery.

Who is the study for?
This trial is for adults aged 18-80 who are having elective multilevel spine surgery (more than two spinal levels) using a posterior approach. They should be able to follow the study protocol and give informed consent. It's not for those with opioid tolerance, long-term gabapentin/pregabalin use, previous surgery at the same spine level, or allergies/contraindications to study medications.Check my eligibility
What is being tested?
The trial is testing if adding continuous ESP catheters with ropivacaine infusion improves recovery and reduces pain and opioid use after multilevel spine surgery compared to ESP catheters with saline/placebo. The ropivacaine or placebo is given for 48 hours post-surgery.See study design
What are the potential side effects?
Possible side effects of ropivacaine may include low blood pressure, nausea, vomiting, headaches, dizziness, allergic reactions or nerve damage. Placebo typically has no direct side effects but does not offer pain relief.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My surgery will be done from the back.
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My surgery involves the lower back, mid-back, or both.
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I am between 18 and 80 years old.
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I am scheduled for a spinal fusion surgery involving more than two spinal levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 month post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 month post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)
Secondary outcome measures
Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement
Duration of use and dose of opioid-iv-pca (if required)
Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ESP Catheters with Ropivacaine 0.2%Experimental Treatment1 Intervention
Group II: ESP Catheters with Saline SolutionPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
242 Previous Clinical Trials
61,858 Total Patients Enrolled
6 Trials studying Postoperative Pain
333 Patients Enrolled for Postoperative Pain

Media Library

Ropivacaine Clinical Trial Eligibility Overview. Trial Name: NCT05494125 — N/A
Postoperative Pain Research Study Groups: ESP Catheters with Ropivacaine 0.2%, ESP Catheters with Saline Solution
Postoperative Pain Clinical Trial 2023: Ropivacaine Highlights & Side Effects. Trial Name: NCT05494125 — N/A
Ropivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05494125 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been added to the research study?

"Affirmative, the details posted on clinicaltrials.gov demonstrate that this medical study is actively recruiting patients. After being put up on September 14th 2022, it was last updated a month later; 44 people are required to be enrolled at one centre."

Answered by AI

Does this clinical trial encompass elderly individuals?

"As delineated in the study's eligibility requirements, potential participants must be at least 18 years old and no older than 80."

Answered by AI

Is this experiment now open to recruitment?

"This clinical trial is still accepting patients, as evidenced by its last update on October 28th. It was initially posted six weeks prior on September 14th."

Answered by AI

Who qualifies to participate in this research project?

"A total of 44 individuals, aged between 18 and 80 who have undergone spinal surgery are eligible for this trial. In addition, applicants should comply with the following conditions: lumbar/thoracic/thoracolumbar fusion operations; readiness to abide by the study protocols; providing informed consent and undergoing a posterior surgical approach."

Answered by AI
~2 spots leftby May 2024