Effect of Lidocaine on Postoperative Pain in Elderlypatients Undergoing Colorectal Cancer Surgery

Colorectal Cancer Clinical Trial

Official title:

Effect of Perioperative Continuous Intravenous Infusion of Lidocaine on Postoperative Pain in Elderly Patients Undergoing Colorectal Cancer Surgery: a Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05920980
• Other study ID #: 2020HX1180
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• 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 to the lidocaine group or placebo group.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 276
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Pain, Postoperative

Intervention

Drug:
• lidocaine
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.
• Placebo
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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	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	Pain scores of movement-evoked pain at postoperative 24 hours	The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain.	up to 24 hours postoperatively
Secondary	Pain scores of movement-evoked pain at postoperative 48 and 72 hours	The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain.	From the date of the end of surgery until the date of 72 hours postoperatively
Secondary	Pain scores of pain at rest at 24, 48 and 72 hours postoperatively	The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain.	From the date of the end of surgery until the date of 72 hours postoperatively
Secondary	The incidence of moderate-to-severe movement-evoked pain at 24, 48 and 72 hours postoperatively	The pain is evaluated using 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 strongest pain.	From the date of the end of surgery until the date of 72 hours postoperatively
Secondary	The incidence of moderate-to-severe pain at rest at 24, 48, and 72 hours postoperatively	The pain is evaluated using 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 strongest pain.	From the date of the end of surgery until the date of 72 hours postoperatively
Secondary	The cumulative morphine consumption at 24, 48, and 72 hours postoperatively	postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator	From the date of the end of surgery until the date of 72 hours postoperatively
Secondary	Time of Bowel function recovery	defined as the time to first defecation or time to first flatusdefined as the time to first defecation or time to first flatus defined as the time to first defecation or time to first flatus	At 3 days after surgery
Secondary	The incidence of postoperative nausea and vomiting during the first 72 hours postoperatively (any nausea or vomiting);	we considered it PONV if patients felt any nausea or had any vomiting	From the date of the end of surgery until the date of 72 hours postoperatively
Secondary	The incidence of a composite of postoperative pulmonary complications during hospitalisation	defined as positive if any component developed before discharge after surgery;	during the period from the end of surgery to discharge, an average of 7 days
Secondary	Length of hospital stay	Length of hospital stay	during the period from the end of surgery to discharge, an average of 7 days
Secondary	Quality of Recovery Scale Score 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).	From the date of the end of surgery until the date of 72 hours postoperatively
Secondary	Incidence of lidocaine toxicity	such as new onset electrocardiogram (ECG) irregularities, drowsiness, light-headedness, metallic taste, peri-oral numbness, and tinnitus	From the time of anesthesia induction until the date of 72 hours postoperatively
Secondary	plasma lidocaine concentration	Blood samples will be collected from some patients in the lidocaine group measurement of lidocaine plasma concentration.	From the time of anesthesia induction until the date of 24hours postoperatively