What side effects are associated with this type of intervention?

The opioid-free anesthetic regimen for laparoscopic surgery, which includes lidocaine, ketamine, dexmedetomidine, and magnesium, has several known side effects. Lidocaine can cause transient neurologic symptoms and, in rare cases, systemic toxicity. Ketamine is associated with postoperative nausea, vomiting, and potential for increased intracranial pressure. Dexmedetomidine may lead to bradycardia, hypotension, and dry mouth. Magnesium can cause hypotension, flushing, and in high doses, respiratory depression. These treatments aim to reduce postoperative opioid consumption and expedite the return of bowel function, but patients should be aware of these potential side effects.

What prior FDA approvals exist?

Lidocaine, ketamine, dexmedetomidine, and magnesium are key components of multimodal pain management strategies approved by the FDA for various uses in anesthesia and pain relief. Lidocaine is approved for local and regional anesthesia, ketamine for anesthesia and pain management, dexmedetomidine for sedation and analgesia, and magnesium is used off-label for its analgesic properties. These drugs are utilized in opioid-free anesthetic techniques to reduce postoperative opioid consumption and expedite recovery in laparoscopic surgeries.

What other types of research exist?

Promising novel alternatives to the current opioid-free anesthetic regimen for laparoscopic surgery patients include: 1) Intravenous acetaminophen, which has shown efficacy in reducing perioperative opioid use and improving pain control. 2) Parecoxib, a COX-2 inhibitor, which has demonstrated effectiveness in managing postoperative pain with a favorable safety profile. 3) Continuous peripheral nerve blocks, such as adductor canal blocks, which provide targeted pain relief and reduce the need for systemic opioids. These alternatives can be considered in multimodal pain management strategies to achieve the desired outcomes.

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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

Must not have

Emergency surgery

Contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of surgery to time of patient discharge from hospital (2-10 days)

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery urgently.

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I cannot have laparoscopic surgery due to certain health issues.

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I am not allergic to any of the drugs used in this study.

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I am unable to give consent by myself.

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I do not have serious heart, lung, liver, or kidney disease.

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I am under 18 years old.

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I am having or have had an open surgery.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of surgery to time of patient discharge from hospital (2-10 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to first flatus

Secondary study objectives

Patient Controlled Analgesia (PCA) morphine consumption

Quality of recovery after surgery

Time to Post-Anesthetic Care Unit (PACU) discharge readiness

+4 more

Awards & Highlights

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.

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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The opioid-free anesthetic regimen for laparoscopic surgery, including lidocaine, ketamine, dexmedetomidine, and magnesium, works through various mechanisms to manage pain and enhance recovery. Lidocaine blocks sodium channels to reduce pain signal transmission, ketamine antagonizes NMDA receptors to provide analgesia and reduce central sensitization, dexmedetomidine inhibits norepinephrine release for sedation and analgesia, and magnesium blocks NMDA receptors and calcium channels to enhance analgesic effects. These combined actions reduce postoperative opioid consumption and expedite bowel function return, minimizing opioid-related side effects and promoting faster recovery for laparoscopic surgery patients.

[Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study].Clonidine versus ketamine to prevent tourniquet pain during intravenous regional anesthesia with lidocaine.