a Pilot Study of Lidocaine Infusion for Postoperative Analgesia in Elderly Patients With Colorectal Cancer Surgery

NCT05412576 | Completed

• 1 other identifier: 2020-1180
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

patients who meet the enrollment criteria will be randomized 1:1:1:1 to the different doses of lidocaine or the placebo group. In the lidocaine groups, at the beginning of surgery, lidocaine 0.5mg/kg, 1.0mg/kg, and 1.5mg/kg per hour were continuously infused (using ideal body weight) respectively during the whole procedure. In contrast, the control group was infused with the same dose of normal saline. All the infusion procedures will be stopped at the end of surgery

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• The incidence of moderate to severe pain (NRS score≥4）during movement (i.e.deep breathing) 24 hours after surgery

  The pain is evaluated using a numbering rating score(NRS).NRS scores range from 0 to 10 points, with 0 points repressing no pain,1-3points repressing mild pain, 4-6 points repressing moderate pain, 7-9 points repressing severe pain, and 10 points repressing the strongest pain.

  The first 24 hours after surgery

Secondary Outcomes (8)

• The blood concentration of lidocaine immediately and 24 hours after the operation

  immediately after the operation; 24 hours after the operation

• The incidence of moderate to severe pain 24 hours after surgery at rest, 48 and 72 hours after surgery, both at rest and during movement

  24 hours after surgery at rest; 48 and 72 hours after surgery, both at rest and during movement

• Incidence of lidocaine toxicity within 72 hours after surgery

  within 72 hours after surgery

• Quality of Recovery Scale Score (QoR-15) at 24, 48, and 72 hours after surgery

  24, 48, and 72 hours after surgery

• Bowel function recovery

  From the end of surgery to discharge, up to 1 week

Study Arms (4)

IVL0.5 group

EXPERIMENTAL

At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure.

Drug: Lidocaine Hydrochloride 2% Injection Solution

IVL1.0 group

EXPERIMENTAL

At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure.

Drug: Lidocaine Hydrochloride 2% Injection Solution

IVL1.5 group

EXPERIMENTAL

At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure.

Drug: Lidocaine Hydrochloride 2% Injection Solution

Placebo group

PLACEBO COMPARATOR

At the beginning of surgery, in the placebo group, the same dose of normal saline as the experimental groups will be given until the procedure is over.

Drug: 0.9% NaCl

Interventions

Lidocaine Hydrochloride 2% Injection Solution DRUG

Injectable

Also known as: IVL 0.5/1.0/1.5group

IVL0.5 group; IVL1.0 group; IVL1.5 group

0.9% NaCl DRUG

Injectable

Also known as: placebo group

Placebo group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 60 years old；
• American Society Anesthesiologygist(ASA)I\~III；
• Patients scheduled for colorectal cancer surgery；
• The surgery takes more than two hours

You may not qualify if:

• BMI≥30kg/㎡or BMI≤18kg/㎡；
• Combined with other organ malignancies；
• Chronic opioid use, substance abuse, contraindication to the use or incompatibility of any drug in the study；
• Patients with liver and kidney insufficiency and chronic pain at the surgical site；
• Accompanied by severe heart disease (such as severe atrioventricular block, severe heart failure, etc.)；
• A history of uncontrolled seizures or acute porphyria；
• Patients who have taken other experimental drugs or participated in or are participating in other clinical trials within 3 months before being enrolled in the study

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jiang Chunling, PhD

  West China Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 9, 2022
• Study Start: June 1, 2021
• Primary Completion: October 24, 2022
• Study Completion: December 25, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)