Opioid-Free Anesthesia for Colorectal Surgery Recovery
(RUMBLE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: University of Saskatchewan

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a new method of anesthesia without using opioids for patients undergoing certain types of surgery. The goal is to reduce the need for opioids after surgery and help patients recover bowel function faster. One of the main drugs used in this method is lidocaine, which can improve recovery and patient satisfaction.

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

I am scheduled for elective colorectal surgery and my health is classified as ASA I-III.

Exclusion Criteria

I need surgery urgently.

I cannot have laparoscopic surgery due to certain health issues.

You are currently pregnant or breastfeeding.

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Participant Groups

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.

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.