IT Injection for Surgery

IU Health University Hospital, Indianapolis, IN
SurgeryESP Block - Drug
18 - 80
All Sexes

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.

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 72 hours after surgery

24 hours after surgery
cumulated oral morphine equivalent (OME)
48 hours after surgery
patient's satisfaction scores
72 hours after surgery
Visual Analog Scale pain scores
Day 7
hospital stay
Hour 72
first ambulation
first flatus
opioid side effects
oral food
oral liquid

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

IT Injection
1 of 2
ESP Block
1 of 2

Active Control

126 Total Participants · 2 Treatment Groups

Primary Treatment: IT Injection · No Placebo Group · Phase 1 & 2

IT Injection
ActiveComparator Group · 1 Intervention: IT Injection · Intervention Types: Drug
ESP Block
ActiveComparator Group · 1 Intervention: ESP Block · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 72 hours after surgery

Who is running the clinical trial?

Indiana UniversityLead Sponsor
914 Previous Clinical Trials
775,705 Total Patients Enrolled
7 Trials studying Surgery
555 Patients Enrolled for Surgery
Amy McCutchan, MDPrincipal InvestigatorIndiana University School of Medicine

Eligibility Criteria

Age 18 - 80 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You prefer to have anesthesia in a specific part of your body for pain management after surgery.
Your body mass index (BMI) is below 40kg/m2.

Frequently Asked Questions

Are there any available positions for volunteers in this experiment?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

How many people are being asked to participate in this research project?

"Yes, that is accurate. The clinical trial described was posted on January 27th and is currently looking for 126 patients at a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.