A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery

Phase 1

• Conditions: 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: Diverticular disease System Organ Class: 100000004856; MedDRA version: 20.0 Level: LLT Classification code 10067878 Term: Bowel resection System Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2017-003835-12-GB
• Lead Sponsor: The University Of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 748

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified