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Trial Title:
Effect of Lidocaine on Postoperative Pain and Long-term Survival in Elderly Patients Undergoing Colorectal Surgery
NCT ID:
NCT06405776
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Pain, Postoperative
Lidocaine
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
lidocaine
Description:
Patients in the lidocaine group, lidocaine 1.5mg/kg/h is continuously infused (using
ideal body weight) during the whole procedure, postoperative analgesia pump with
lidocaine (lidocaine 50mg/kg, sufentanil 2ug/kg, glassetron 12mg) diluted to 200ml with
saline until 72h after surgery.
Arm group label:
Lidocaine group
Intervention type:
Drug
Intervention name:
Placebo
Description:
In the placebo group, the same volume of normal saline will be administered during
anesthesia. The postoperative PCIA device will contain sufentanil 2μg/kg, granisetron
12mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 mL.
Arm group label:
Placebo group
Summary:
This study is a further observation and follow-up of the patients enrolled in the
registration number NCT05920980 to further evaluate the effect of long-term infusion of
lidocaine on postoperative chronic pain, long-term quality of life and survival rate in
patients undergoing colorectal cancer surgery.
Detailed description:
This study is a further observation and follow-up of the patients enrolled in the
registration number NCT05920980 to further evaluate the effect of long-term infusion of
lidocaine on postoperative chronic pain, long-term quality of life and survival rate in
patients undergoing colorectal cancer surgery. Patients who meet the enrollment criteria
will be randomized 1:1 to the lidocaine group or placebo group. In the lidocaine group,
lidocaine 1.5mg/kg/h was continuously infused (using ideal body weight) during the whole
procedure. Postoperative analgesia pump with lidocaine (lidocaine 50mg/kg, sufentanil
2ug/kg, glassetron 12mg) diluted to 200ml with saline until 72h after surgery. In the
placebo group, the same volume of normal saline will be administered during anesthesia.
The postoperative PCIA device will contain sufentanil 2μg/kg, granisetron 12mg diluted to
200mL in 0.9% normal saline solution with a total volume of 200mL.Follow-up after
discharge includes chronic pain, the impact of chronic pain on quality of life, the
relapse-free survival and overall survival from postoperative 3 months to 5 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants were at least 60 years old;
2. American Society of Anesthesiologists (ASA) physical status I to III;
3. Body-mass index of 18-30 kg/m2;
4. Scheduled for elective colorectal surgery.
Exclusion Criteria:
1. Metastases occurring in other distant organs;
2. Severe hepatic insufficiency (aspartate aminotransferase or alaninetransaminase or
bilirubin >2.5 times the upper limit of normal);
3. Renal impairment (creatinine clearance <60 mL/min);
4. Cardiac rhythm disorders or systolic heart failure (second-and thirddegree heart
block, ejection fraction <50%);
5. Allergies to any of the trial drugs; chronic opioid use;
6. Inability to comprehend numeric rating scale.
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
China
Address:
City:
Sichuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Mao Ye
Phone:
13540432883
Email:
838915882@qq.com
Start date:
June 5, 2023
Completion date:
June 1, 2027
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06405776
