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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
cumulated oral morphine equivalent (OME)
Secondary study objectives
Visual Analog Scale pain scores
first ambulation
first flatus
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,218,932 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
~19 spots leftby May 2025
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