Clinical trial NCT04144933: Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
Official title: A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Anesthesia
General Anesthesia
Analgesics, Opioid
Opioid Free Anesthesia
Postoperative Ileus
Colorectal Surgery
Laparoscopic Surgery
Analgesia
Dexmedetomidine
Lidocaine
Ketamine
Keywords: Opioid-free
Opioid-sparing
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time to first flatus
timeFrame: End of surgery to first flatus (1-4 days)
Secondary outcomes:
measure: Time to first defecation
timeFrame: End of surgery to first defecation (1-7 days)
measure: Time to tolerance of oral intake
timeFrame: End of surgery to first oral intake (1-3 days)
measure: Total Post-Anesthetic Care Unit (PACU) opioid consumption
timeFrame: End of surgery to discharge from PACU (1-2 hours)
measure: Patient Controlled Analgesia (PCA) morphine consumption
timeFrame: End of surgery to 48 hours postoperatively
measure: Time to Post-Anesthetic Care Unit (PACU) discharge readiness
timeFrame: End of surgery to PACU discharge readiness (1-3 hours)
measure: Visual Analogue Scale (VAS) pain scores
timeFrame: End of surgery to 48 hours postoperatively
measure: Quality of recovery after surgery
timeFrame: End of surgery to time of patient discharge from hospital (2-10 days)
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
References: