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Opioid-Free Anesthesia for Colorectal Surgery Recovery (RUMBLE Trial)
Phase 3
Recruiting
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18
American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of surgery to time of patient discharge from hospital (2-10 days)
Awards & highlights
RUMBLE Trial Summary
This trial will compare the effects of two types of anesthesia on post-operative opioid consumption and bowel function.
Who is the study for?
This trial is for adults over 18 who are in good health (ASA class I-III) and scheduled for elective laparoscopic colorectal surgery. It's not suitable for those with allergies to study drugs, significant organ diseases, inability to consent or use pain assessment tools, pregnant or breastfeeding women, or those needing open/emergency surgery.Check my eligibility
What is being tested?
The study tests if a general anesthetic technique without opioids—using lidocaine, ketamine, dexmedetomidine, and magnesium—can reduce the need for postoperative opioids and speed up the return of bowel function after laparoscopic colorectal surgery compared to traditional methods.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site from lidocaine or other medications used like ketamine and dexmedetomidine. These can range from mild irritation to more serious symptoms depending on individual responses.
RUMBLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I am scheduled for elective colorectal surgery and my health is classified as ASA I-III.
RUMBLE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of surgery to time of patient discharge from hospital (2-10 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of surgery to time of patient discharge from hospital (2-10 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first flatus
Secondary outcome measures
Patient Controlled Analgesia (PCA) morphine consumption
Quality of recovery after surgery
Time to Post-Anesthetic Care Unit (PACU) discharge readiness
+4 moreRUMBLE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Opioid-free General Anesthesia (OFA)Experimental Treatment4 Interventions
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
Group II: Traditional Opioid-containing General Anesthesia (TOA)Active Control4 Interventions
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
Find a Location
Who is running the clinical trial?
University of SaskatchewanLead Sponsor
251 Previous Clinical Trials
154,350 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery urgently.I cannot have laparoscopic surgery due to certain health issues.You are currently pregnant or breastfeeding.I am not allergic to any of the drugs used in this study.I am unable to give consent by myself.I am older than 18 years.I do not have serious heart, lung, liver, or kidney disease.I am scheduled for elective colorectal surgery and my health is classified as ASA I-III.I am under 18 years old.I am having or have had an open surgery.You are unable to communicate your level of pain.
Research Study Groups:
This trial has the following groups:- Group 1: Traditional Opioid-containing General Anesthesia (TOA)
- Group 2: Opioid-free General Anesthesia (OFA)
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What are some common conditions that Dexamethasone and Ondansetron help alleviate?
"Dexamethasone and Ondansetron can be used in the treatment of macular edema, minor burns, and certain eye conditions."
Answered by AI
Are there any other similar treatments to Dexamethasone and Ondansetron that have been trialed?
"According to the latest data, there are 1091 ongoing clinical trials involving Dexamethasone and Ondansetron. Of these, 264 are in Phase 3. The majority of trials for this treatment are based in Mishawaka, Indiana; however, there are 21187 locations running studies for this medication overall."
Answered by AI
Are there any possible risks to taking Dexamethasone and Ondansetron?
"There is some evidence supporting the efficacy of Dexamethasone, Ondansetron, and thus it received a score of 3."
Answered by AI
Could you direct me to where I can sign up for this clinical trial?
"From what is published on clinicaltrials.gov, it appears as though this research project is still looking for individuals to participate. The study was originally announced on May 15th, 2021 with the most recent update coming October 31st, 2022. So far, only 1 site has been recruited for the 60 person goal."
Answered by AI
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