None listed
Conditions
Brief summary
This trial aims to assess if the addition of a post-operative lidocaine infusion results in an earlier return of bowel function in adult patients undergoing elective laparoscopic colorectal surgery. This will be determined by the time to first passage of wind or the passage of bowel motion and the tolerance of solid diet. Patients will be randomised and allocated to either placebo or lidocaine infusion. The allocation will be blinded and the patient and all researchers involved will be blinded throughout the duration of the study. The differences in the return of gastrointestinal function post-operatively between the two groups will then be assessed to determine if lidocaine has an effect on bowel function. Delay in the return of bowel function after bowel surgery can manifest as nausea, vomiting, abdominal distention and absence of passing wind or bowel motions. These symptoms are important as they are the most frequent cause of delayed recovery and prolonged hospital stay. The only time commitment required for patients involved in this study would be to record when they first pass wind, pass a bowel motion, and tolerted a solid meal. The safety of patients involved in the study would be ensured by following the protocol already in place at Austin Health for post-operative lidocaine infusion.
Interventions
The intervention of this study is the administration of 24 hours of postoperative lidocaine intravenous continuous drip infusion at a rate of 1mg/kg/hr. Made up by pharmacy and administered by an experienced anesthetist. The infusion will be set up and placed in a locked and secured box to avoid accidental tampering.
The infusion will continue as originally set up until the completion of the 24 hour infusion.
Intraoperative lidocaine infusions are now standard practice for colorectal resectio
The intervention of this study is the administration of 24 hours of postoperative lidocaine intravenous continuous drip infusion at a rate of 1mg/kg/hr. Made up by pharmacy and administered by an experienced anesthetist. The infusion will be set up and placed in a locked and secured box to avoid accidental tampering. The infusion will continue as originally set up until the completion of the 24 hour infusion. Intraoperative lidocaine infusions are now standard practice for colorectal resections at Austin hospital and therefore this will be administered to both exposure and placebo group during the study period. This will be run at a standard rate of 1.5mg/kg intraoperatively. At the completion of the case but before extubation, the patient will then be allocated to lidocaine or placebo. In the intervention arm, the lidocaine infusion will run at 1mg/kg/hr for 24 hours. The infusion will be setup immediately at the completion of surgery prior to extubation and continue to run until 24 hours later.
Sponsors
Dr Rebecca Shine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
INCLUSION CRITERIA All patients >18 years undergoing elective laparoscopic/hybrid colorectal resections for benign or malignant conditions at Austin hospital during the study period.
Exclusion criteria
Contraindications to IV lidocaine: • Known history of allergy or hypersensitivity to Lidocaine (lignocaine) or other amide-type local anaesthetic. • Stokes-Adams syndrome or any type of heart block or other high-risk arrhythmias. • Severe shock • Myasthenia gravis • Serious diseases of the CNS or of the spinal cord Other exclusion criteria: • Childs Pugh A or worse liver disease • CKD with eGFR <40ml/hr • Chronic use of opioid analgesia or local anesthetics • Patients will be excluded if they were unable to participate in postoperative assessments because of language difficulty, postoperative confusion, or cognitive impairment.
Outcome results
None listed