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

Sponsor

University of Saskatchewan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04144933

Collaborator

(none)

Enrollment

Location

Arms

15.6

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia General Anesthesia Analgesics, Opioid Opioid Free Anesthesia Postoperative Ileus Colorectal Surgery Laparoscopic Surgery Analgesia Dexmedetomidine Lidocaine Ketamine	Drug: Acetaminophen, Gabapentin Drug: Acetaminophen, Gabapentin Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine Drug: Dexamethasone, Ondansetron Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate Drug: Lidocaine 1% Injectable Solution, Sufentanil Drug: Sevoflurane, Sufentanil	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 15, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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-free 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

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-free 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

Outcome Measures

Primary Outcome Measures

Time to first flatus [End of surgery to first flatus (1-4 days)]
Time between the end of surgery and the movement when the patient first passes flatus

Secondary Outcome Measures

Time to first defecation [End of surgery to first defecation (1-7 days)]
Time between the end of surgery and the moment the patient first passes stool
Time to tolerance of oral intake [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
Total Post-Anesthetic Care Unit (PACU) opioid consumption [End of surgery to discharge from PACU (1-2 hours)]
Total amount of opioid (morphine equivalents) required in PACU
Patient Controlled Analgesia (PCA) morphine consumption [End of surgery to 48 hours postoperatively]
Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively
Time to Post-Anesthetic Care Unit (PACU) discharge readiness [End of surgery to PACU discharge readiness (1-3 hours)]
Time to Post-Anesthetic Care Unit (PACU) discharge readiness
Visual Analogue Scale (VAS) pain scores [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
Quality of recovery after surgery [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)