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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

60

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

May 15, 2021

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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