Patients scheduled for elective colorectal resection for colorectal cancer or diverticular disease. MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10013534 Term: Div
Conditions
Interventions
Trade Name: Lidocaine 2%
Product Name: Lidocaine 2%
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lidocaine
CAS Numbe
Sponsors
The University Of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients scheduled for elective colorectal resection for colorectal cancer or diverticular disease at participating UK colorectal surgery units. Right hemicolectomy, extended right hemicolectomy, left colectomy, sigmoid colectomy, subtotal colectomy with ileosigmoid or ileorectal anastomosis and high anterior resection are eligible Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 187 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 561
Exclusion criteria
Exclusion criteria: Planned epidural anaesthesia Planned regional or local infiltration of lidocaine at the same time as lidocaine infusion Current pregnancy or breast feeding Age <18 years Patients lacking capacity to give informed consent. Known or suspected allergy to lidocaine or amide-type local anaesthetics Current complete heart block Current severe liver dysfunction (Child’s A or greater) Current renal failure (eGFR<30) Patients participating in the active intervention phase of another therapeutic clinical trial (or other interventional trial) unless a co-enrollment agreement is in place Patients having surgery for indications other than colorectal cancer/diverticular disease Rectal cancer below the peritoneal reflection in which total mesorectal excision is anticipated Rectal cancer patients who have received any neoadjuvant radiotherapy A preoperative surgical plan to form any new stoma during the primary procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim is an effectiveness analysis to measure whether intravenous lidocaine (given at time of surgery) achieves faster return of gut function for more patients after colorectal surgery. The primary outcome will be the proportion of randomised subjects compared between IV lidocaine and placebo that have achieved return of gut function at 72 hours after their surgery. This will be measured by ‘GI-3 recovery’ -an endpoint defined as achievement of both of the following two events: tolerating diet (defined as ingestion of food and drink without significant nausea or vomiting for 3 consecutive meals) and passage of flatus OR stool (whichever comes first).; Secondary Objective: • to measure whether perioperative intravenous lidocaine is effective in achieving faster postoperative return of gut function measured by GI-2 recovery (defined as the time to the later of the following two events (both must be achieved): time to tolerating diet, and time to first passage of stool. • to detect an absolute reduction of 10% (from 20% to 10%) in the rate of Prolonged Postoperative Ileus (PPOI= failure to establish GI-3 by postoperative day 5) • to detect a reduction in postoperative nausea and vomiting • to measure any difference in analgesia requirements • to assess quality of postoperative recovery using multi-dimensional patient-reported outcome tools and quality of life tools, as well as assessing time to medically-defined and patient-defined readiness for discharge from hospital • To measure the impact on recovery of variation in perioperative care from Enhanced Recovery after Surgery guidelines • To assess whether perioperative intravenous lidocaine during colore ;Primary end point(s): The primary outcome will be the proportion of randomised subjects compared between IV lidocaine and placebo that have achieved return of gut functi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to return of gut function using the GI-3 recovery definition (a composite endpoint defined as time from surgery to the later time to establish both of the following two events: time to tolerating diet without significant nausea or vomiting for 3 consecutive meals and time to first passage of flatus or stool) time from start of operation to event Time to return of gut function using the GI-2 recovery definition (a composite endpoint defined as time from surgery to the later time to establish both of the following two events: tolerating solid food without significant nausea or vomiting for 3 consecutive meals and first passage of stool) a) Yes/No outcome at 96 hours after start of operation; b) time to event proportion of participants achieving GI-2 recovery at 96 hours; 96 hours after start of operation Prolonged Postoperative Ileus (PPOI= failure to establish GI-3 by 120 hours after surgery (postoperative day 5)) Measurement variable: GI-3 recovery 120 hours after start of operation Nausea and vomiting Measurement variables: daily PONV score; number of episodes of vomiting/day (defined as episodes of expulsion of gastric content); total dosage of rescue antiemetic PONV questionnaire: total number episodes vomiting within 72 hours of operation; total dose rescue antiemetic within 72 hours of operation daily until 72 hours after start of operation Quality of analgesia Measured by OBAS score daily in-hospital up to and including postoperative day 7. Total postoperative opioid consumption morphine equivalent doses, cumulative total until 72 hours after start of operation Quality of Recovery Quality of recovery score (15-question patient-reported outcome measure) daily | — |
Countries
United Kingdom
Contacts
Public ContactSarah Cameron
University of Aberdeen
Outcome results
None listed