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Opioid Analgesic
Intrathecal Morphine for Postoperative Pain
Phase 4
Recruiting
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
General anesthesia with anticipated intraoperative extubation
Age 18-80 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours postoperative
Awards & highlights
Study Summary
This trial is testing whether intrathecal morphine will decrease postoperative pain and analgesic consumption after VATS.
Who is the study for?
This trial is for adults aged 18-80 undergoing elective lung surgery (VATS) with expected immediate recovery from anesthesia. Candidates must understand English and not have severe health issues like advanced organ diseases, drug or alcohol abuse, chronic pain conditions, or be on life support treatments.Check my eligibility
What is being tested?
The study tests if a single dose of intrathecal morphine (5 mcg/kg) can better manage post-surgery pain compared to a placebo in patients after VATS. It's randomized and double-blinded, meaning neither the doctors nor the patients know who gets the real medicine versus the placebo.See study design
What are the potential side effects?
Morphine may cause side effects such as nausea, vomiting, itching, drowsiness, constipation, respiratory depression (slow breathing), and potential for addiction or tolerance with long-term use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will be put to sleep during surgery and wake up afterwards.
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I am between 18 and 80 years old.
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I will be put to sleep during surgery and expected to breathe on my own afterwards.
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I am scheduled for a minimally invasive lung surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month and 3 months after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month and 3 months after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative morphine equivalent consumption
Secondary outcome measures
Number of pain interventions
Postoperative opioid related side effects
Postoperative pain
+4 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: MorphineActive Control1 Intervention
Intrathecal morphine
Group II: PlaceboPlacebo Group1 Intervention
Intrathecal saline
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,003 Previous Clinical Trials
819,659 Total Patients Enrolled
1 Trials studying Postoperative Pain
200 Patients Enrolled for Postoperative Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood does not clot normally before surgery.I will be put to sleep during surgery and wake up afterwards.I have a bleeding disorder.I am on a breathing machine before surgery.I cannot understand English.I am between 18 and 80 years old.I expect to be on a breathing machine after surgery.I will be put to sleep during surgery and expected to breathe on my own afterwards.I have a serious liver condition.You have a history of using opioids or alcohol excessively.You are allergic to morphine.I have used a heart support device before surgery.I have kidney failure.I need home oxygen or take oral steroids for my lung condition.I experience chronic pain.I am scheduled for a minimally invasive lung surgery.I have chosen not to participate in the trial.I currently have an infection.My health is extremely poor, making me a high-risk surgery patient.I have received drugs through an IV to help my heart pump or to control my blood pressure before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Morphine
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial admit minors as participants?
"As specified by the inclusion criteria, only people aged 18 to 80 can be a part of this clinical trial. Yet, there are 69 medical studies specifically for those under 18 and 369 trials designed for participants above 65 years old."
Answered by AI
Has the FDA sanctioned Morphine for medical use?
"The safety of Morphine was assessed to be a 3 due to its Phase 4 trial status, which indicates that it is already approved and has been thoroughly studied."
Answered by AI
Are there any eligibility criteria for participating in this trial?
"This clinical study requires 90 volunteers with post-operative pain and ages ranging between 18 to 80 years old. Aspiring participants must possess the following qualifications: Age between 18 - 80, scheduled for elective video-assisted thoracoscopic surgery of a lung resection under general anaesthesia that will result in extubation."
Answered by AI
Are there still opportunities to participate in this research endeavor?
"According to clinicaltrials.gov, this study is not presently seeking participants as it was posted on 1/1/2023 and last updated 11/2/2022. Nevertheless, there are 483 other trials currently recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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