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Trial Title:
Effect of Lidocaine on Postoperative Pain in Elderlypatients Undergoing Colorectal Cancer Surgery
NCT ID:
NCT05920980
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Pain, Postoperative
Lidocaine
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients were randomized in a 1:1 lidocaine group, placebo control group using a
computer-generated random number table. After the randomization scheme is written, use
the opaque envelope, hide each group envelope into an opaque envelope, the envelope
outside the code, is sealed to the researcher, when the study, if the inclusion criteria,
then open the corresponding numbered envelope, and intervene according to the group
scheme in the envelope.
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Blinding of research personnel and patients will be maintained throughout the observation
period. On the day of surgery, nurses who did not participate in the perioperative
management will assign the standard configuration of the trial drugs, including
intraoperative medication and the configuration of the postoperative analgesic pump, to
the researchers before the induction of anesthesia. Throughout the study, the patients
and researchers should not be unblinded until the statistical analysis of the study data
is completed.
During the operation, an independent anesthesiologist will be responsible for the blood
draw, and the postoperative blood samples will be collected together with the routine
blood examination specimens. The investigators remained blinded throughout the
observation period until the anesthesiologist or assessors observe significant adverse
events of local general anesthesia toxicity.
Intervention:
Intervention type:
Drug
Intervention name:
lidocaine
Description:
Patients in the lidocaine groups, 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. Blood samples will be collected from some patients in the
lidocaine group for the measurement of lidocaine plasma concentration.
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 2 μg/kg, granisetron 12
mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 mL.
Arm group label:
Placebo group
Other name:
placebo group
Summary:
Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group
or placebo group.
Detailed description:
Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group
or placebo group. In the lidocaine groups, 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. Blood samples will be collected from some patients in the
lidocaine group for the measurement of lidocaine plasma concentration.In the placebo
group, the same volume of normal saline will be administered during anesthesia. The
postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to
200 mL in 0.9% normal saline solution with a total volume of 200 mL.
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 alanine transaminase 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 third-degree 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:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Start date:
June 5, 2023
Completion date:
June 1, 2024
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/NCT05920980
