Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery (RUMBLE)

December 19, 2023 updated by: Jonathan Gamble, University of Saskatchewan

A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery

The objective of this study is to determine if an opioid-free general anesthetic (OFA) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to traditional opioid-containing general anesthetic techniques. It is hypothesized that this intraoperative OFA regimen will reduce postoperative opioid consumption, and expedite return of bowel function in this population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery when compared with traditional opioid-containing techniques.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18, American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery

Exclusion Criteria:

  • Emergency surgery, open surgery, contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum), American Society of Anesthesiology (ASA) class 4, age < 18, pregnant or breastfeeding women, significant cardiorespiratory/hepatic/renal disease, allergy to any study drugs, inability to consent, inability to respond to pain assessments, inability to use the patient controlled analgesia device (PCA)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
Drug: Acetaminophen, Gabapentin
975 mg, 300 mg
Other Names:
  • Opioid-containing preoperative medications
Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine
1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg
Other Names:
  • Opioid-free pre-intubation medications
Drug: Dexamethasone, Ondansetron
6 mg, 4 mg
Other Names:
  • Postoperative nausea and vomiting prophylaxis
Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate
Dose titrated to effect, 1.5 mg/kg/hr, 0.15 mg/kg/hr, 0.3 -1 mcg/kg/hr (titrated to effect), 30 mg/kg bolus over 30 minutes
Other Names:
  • Opioid-free maintenance medications
Active Comparator: Traditional Opioid-containing General Anesthesia (TOA)
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
Drug: Acetaminophen, Gabapentin
975 mg, 300 mg
Other Names:
  • Opioid-containing preoperative medications
Drug: Dexamethasone, Ondansetron
6 mg, 4 mg
Other Names:
  • Postoperative nausea and vomiting prophylaxis
Drug: Lidocaine 1% Injectable Solution, Sufentanil
0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)
Other Names:
  • Opioid-containing pre-intubation medications
Drug: Sevoflurane, Sufentanil
Dose titrated to effect, As needed (dose at anesthesiologist's discretion)
Other Names:
  • Opioid-containing maintenance medications

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to first flatus
Time Frame: End of surgery to first flatus (1-4 days)
Time between the end of surgery and the movement when the patient first passes flatus
End of surgery to first flatus (1-4 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first defecation
Time Frame: End of surgery to first defecation (1-7 days)
Time between the end of surgery and the moment the patient first passes stool
End of surgery to first defecation (1-7 days)
Time to tolerance of oral intake
Time Frame: End of surgery to first oral intake (1-3 days)
Time between the end of surgery to when the patient can tolerate any oral solid food intake
End of surgery to first oral intake (1-3 days)
Total Post-Anesthetic Care Unit (PACU) opioid consumption
Time Frame: End of surgery to discharge from PACU (1-2 hours)
Total amount of opioid (morphine equivalents) required in PACU
End of surgery to discharge from PACU (1-2 hours)
Patient Controlled Analgesia (PCA) morphine consumption
Time Frame: End of surgery to 48 hours postoperatively
Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively
End of surgery to 48 hours postoperatively
Time to Post-Anesthetic Care Unit (PACU) discharge readiness
Time Frame: End of surgery to PACU discharge readiness (1-3 hours)
Time to Post-Anesthetic Care Unit (PACU) discharge readiness
End of surgery to PACU discharge readiness (1-3 hours)
Visual Analogue Scale (VAS) pain scores
Time Frame: End of surgery to 48 hours postoperatively
Visual Analogue Scale (VAS) pain scores will be recorded on a scale of 0 to 10, with 0 indicating no pain, and 10 indicating extreme pain, 48 hours following surgery
End of surgery to 48 hours postoperatively
Quality of recovery after surgery
Time Frame: End of surgery to time of patient discharge from hospital (2-10 days)
Assessed using the Quality of Recovery (QoR) 15 questionnaire, a validated tool for measuring quality of recovery after anesthesia and surgery
End of surgery to time of patient discharge from hospital (2-10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIO-625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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