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Intrathecal Opioid for Surgery

Phase 1 & 2

Recruiting

Led By Amy McCutchan, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours after surgery

Awards & highlights

Study Summary

This trial is comparing two methods of pain control after laparoscopic colorectal surgery to see which is more effective. Group 1 will get a small dose of drugs injected into the spinal fluid, while group 2 will get drugs injected near the nerves under a muscle.

Who is the study for?

This trial is for adults aged 18-80 undergoing elective laparoscopic colorectal surgery, with a BMI under 40 and an ASA Class of 1-3. They must want regional anesthesia for pain control post-surgery. Excluded are those with certain medical conditions like high brain pressure (except pseudo-tumor cerebri), infections at the injection site, severe liver or kidney disease, heavy daily opioid use, recent substance abuse, known allergies to study drugs, or any condition that might skew pain measurement.Check my eligibility

What is being tested?

The study compares two pain management methods after laparoscopic colorectal surgery: Group 1 receives an intrathecal injection delivering duramorph and bupivacaine into spinal fluid; Group 2 gets an erector spinae plane block where bupivacaine and decadron are injected near back nerves under a muscle.See study design

What are the potential side effects?

Possible side effects include discomfort at the injection site, allergic reactions to medications used (morphine, bupivacaine, decadron), potential nerve injury from needle placement during the ESP block or IT injection procedures. Side effects can vary based on individual patient factors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours after 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

cumulated oral morphine equivalent (OME)

Secondary outcome measures

Visual Analog Scale pain scores

first ambulation

first flatus

+6 more

Trial Design

2Treatment groups

Active Control

Group I: ESP BlockActive Control1 Intervention

an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.

Group II: IT InjectionActive Control1 Intervention

an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,150 Total Patients Enrolled

7 Trials studying Surgery

555 Patients Enrolled for Surgery

Amy McCutchan, MDPrincipal InvestigatorIndiana University School of Medicine

Media Library

ESP Block Clinical Trial Eligibility Overview. Trial Name: NCT05257941 — Phase 1 & 2

Surgery Research Study Groups: ESP Block, IT Injection

Surgery Clinical Trial 2023: ESP Block Highlights & Side Effects. Trial Name: NCT05257941 — Phase 1 & 2

ESP Block 2023 Treatment Timeline for Medical Study. Trial Name: NCT05257941 — Phase 1 & 2

Frequently Asked Questions

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

Are there any available positions for volunteers in this experiment?

"Yes, this information is accurate. The latest update on clinicaltrials.gov was on February 22nd, 2022 and the trial is still recruiting patients that match the eligibility criteria."

Answered by AI

How can I become a part of this research project?

"This clinical study is looking for 126 individuals who are between 18 and 80 years old and have already undergone surgery. In addition, patients must also meet the following requirements: they must be undergoing an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital, they must have a BMI of less than 40kg/m2, they must desire regional anesthesia for postoperative pain control, and they must be ASA Class 1, 2, or 3 according to the American Society of Anesthesiologists physical status classification system."

Answered by AI

Are participants in this trial required to be of majority age?

"Eligibility for this study includes patients aged 18-80. In total, there are 32 clinical trials underway involving patients that are minors and 246 with elderly participants."

Answered by AI