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Procedure

Intervention group for Opioid Use Disorder

N/A

Recruiting

Led By Naveed Siddiqui, MD

Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ASA physical status I-III

IBD abdominal laparoscopic assisted surgeries under general anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours, 48 hours and 72 hours postoperatively

Awards & highlights

Study Summary

This trial will test the effect of a procedure called an ESP block on patients' recovery after surgery. The study will be conducted on two groups: one will receive the ESP block with anesthetic, and

Who is the study for?

This trial is for patients with Inflammatory Bowel Disease (IBD) who may also have issues with opioid use. Participants should be preparing for surgery and willing to receive an ultrasound-guided ESP block, which is a type of pain management technique.Check my eligibility

What is being tested?

The study tests the effectiveness of the Erector Spinae Plane (ESP) block in improving recovery quality and reducing opioid need after surgery. Patients will randomly get either Ropivacaine (anesthetic) or saline solution in their ESP block before surgery.See study design

What are the potential side effects?

Ropivacaine can cause side effects like low blood pressure, nausea, vomiting, dizziness, numbness around the injection site, or allergic reactions. Saline solution generally has minimal to no side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My health is good to moderately impaired.

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I have had laparoscopic surgery for IBD under general anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours, 48 hours and 72 hours postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours, 48 hours and 72 hours postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours, 48 hours and 72 hours postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of Recovery (via QoR-15) total score

Secondary outcome measures

Opioid consumption

Opioid related side effects

The hospital LOS

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intervention groupActive Control1 Intervention

Ultrasound guided bilateral ESP block either with local anesthetic

Group II: Control groupPlacebo Group1 Intervention

Ultrasound guided bilateral ESP block either with normal saline

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor

127 Previous Clinical Trials

11,147 Total Patients Enrolled

Naveed Siddiqui, MDPrincipal InvestigatorAssociate Professor

6 Previous Clinical Trials

483 Total Patients Enrolled

Frequently Asked Questions

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

Which specific criteria must individuals meet in order to be eligible for participation in this research study?

"To be eligible for enrollment in this research, potential participants must meet the criteria of having opioid use disorder and fall within the age range of 18 to 85. A total of 90 individuals will be sought after for participation in this trial."

Answered by AI

Is the enrollment phase of this medical study currently accepting participants?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is currently in search of suitable candidates. The initial posting was made on July 21st, 2021, and the most recent update occurred on January 26th, 2024. For this study, a total of 90 patients will be enrolled at one specific site."

Answered by AI

Does this medical study include individuals who are above the age of 80?

"In order to participate in this clinical trial, patients must be between the ages of 18 and 85. It is worth noting that there are a total of 53 studies specifically catering to patients under the age of 18, while another 226 studies target individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Erector Spinae Plane (ESP) Block in Patients With Inflammatory Bowel Disease (IBD)

Dr. Naveed Siddiqui 2021. "Efficacy of Erector Spinae Plane (ESP) Block in Patients With Inflammatory Bowel Disease (IBD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06230003.

All > Inflammatory Bowel Disease > Ibd