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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05412576
• Other study ID #: 2020-1180
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 25, 2022

Study information

• Verified date: March 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 25, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Lidocaine Hydrochloride 2% Injection Solution
Injectable
• 0.9% NaCl
Injectable

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The blood concentration of lidocaine immediately and 24 hours after the operation	Immediately after the operation and 24 hours after the procedure, the researchers drew 3ml of blood respectively from patients to detect the blood concentration of lidocaine.	immediately after the operation; 24 hours after the operation
Secondary	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	The pain will be evaluated using a numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain, and 10 points representing the sharpest pain.	24 hours after surgery at rest; 48 and 72 hours after surgery, both at rest and during movement
Secondary	Incidence of lidocaine toxicity within 72 hours after surgery	the occurrence of one or more adverse events including tingling/pins and needles, especially around the eyes and mouth, ringing in the ears, dizziness, visual disturbances, and metallic taste.	within 72 hours after surgery
Secondary	Quality of Recovery Scale Score (QoR-15) at 24, 48, and 72 hours after surgery	The global QoR-15 score ranges from 0 to 150 and is categorized as five quality of recovery dimensions, including physical comfort (5 items), emotional state (4 items), psychological support (2 items), physical independence (2 items), and pain (2 items). Each piece is graded using an 11-point Likert scale. The QoR is classified according to the QoR-15 score as excellent (QoR-15 > 135), good (122 = QoR-15 = 135), moderate (90 = QoR-15 = 121) and poor (QoR-15 < 90).	24, 48, and 72 hours after surgery
Secondary	Bowel function recovery	defined as the time to first defecation or the time to first flatus	From the end of surgery to discharge, up to 1 week
Secondary	Incidence of adverse reactions to opioids within three days after surgery	It is defined as if patients happened any constipation, nausea, vomiting, drowsiness, dizziness, itchy skin, confusion, respiratory depression, etc.	within three days after surgery
Secondary	The incidence of a composite of postoperative pulmonary complications during hospitalization	defined as positive if any component developed before discharge after surgery; These complications included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis	from the end of surgery to discharge, up to 1 week
Secondary	Length of hospital stay	determined by the number of days from admittance to discharge	from the end of surgery to discharge, up to 1 month.