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

Anesthesia Clinical Trial

— RUMBLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144933
• Other study ID #: BIO-625
• Status: Recruiting
• Phase: Phase 3
• Start date: May 15, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2023
• Source: University of Saskatchewan
• Contact: Jonathan Gamble, MD
• Phone: 306-655-1183
• Email: jonathan.gamble[@]saskhealthauthority.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Analgesia
• Analgesics, Opioid
• Anesthesia
• Colorectal Surgery
• Dexmedetomidine
• General Anesthesia
• Ketamine
• Laparoscopic Surgery
• Lidocaine
• Opioid Free Anesthesia
• Postoperative Ileus

Intervention

Drug:
• Acetaminophen, Gabapentin
975 mg, 300 mg
• Acetaminophen, Gabapentin
975 mg, 300 mg
• Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine
1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg
• Dexamethasone, Ondansetron
6 mg, 4 mg
• 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
• Lidocaine 1% Injectable Solution, Sufentanil
0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)
• Sevoflurane, Sufentanil
Dose titrated to effect, As needed (dose at anesthesiologist's discretion)

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

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