Clinical trial NCT05412576: a Pilot Study of Lidocaine Infusion for Postoperative Analgesia in Elderly Patients With Colorectal Cancer Surgery
Official title: a Pilot Randomized Controlled Trial on the Safety and Efficacy of Different Doses of Lidocaine Infusion for Postoperative Analgesia in Elderly Patients With Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 220
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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. Subsequently, all subjects will receive an analgesic device named Patient-Controlled Intravenous Analgesia pump, briefly, PCIA pump during the first 72 postoperative hours. PCIA pump contains lidocaine 30mg/kg, sufentanil 2 μg/kg, and granisetron 12 mg diluted to 200 mL in 0.9 % normal saline, while in the placebo group, the lidocaine will be replaced with the equal dose of 0.9% normal saline and other components unchanged. All the background infusions of PCIA will be set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The incidence of moderate to severe pain (NRS score≥4）during movement (i.e.deep breathing) 24 hours after surgery
timeFrame: The first 24 hours after surgery
Secondary outcomes:
measure: The blood concentration of lidocaine immediately and 24 hours after the operation
timeFrame: immediately after the operation; 24 hours after the operation
measure: 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
timeFrame: 24 hours after surgery at rest; 48 and 72 hours after surgery, both at rest and during movement
measure: Incidence of lidocaine toxicity within 72 hours after surgery
timeFrame: within 72 hours after surgery
measure: Quality of Recovery Scale Score (QoR-15) at 24, 48, and 72 hours after surgery
timeFrame: 24, 48, and 72 hours after surgery
measure: Bowel function recovery
timeFrame: From the end of surgery to discharge, up to 1 week
measure: Incidence of adverse reactions to opioids within three days after surgery
timeFrame: within three days after surgery
measure: The incidence of a composite of postoperative pulmonary complications during hospitalization
timeFrame: from the end of surgery to discharge, up to 1 week
measure: Length of hospital stay
timeFrame: from the end of surgery to discharge, up to 1 month.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Jiang Chunling, PhD
role: STUDY_DIRECTOR
References: