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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Placebo; Drug: lidocaine

• Registration Number: NCT05920980
• Lead Sponsor: West China Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-02
• Study Start: 2023-06-05
• Study First Submitted QC: 2023-06-24
• Study First Posted: 2023-06-27
• Primary Completion: 2025-01-13
• Study Completion: 2025-01-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	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.
Lidocaine group	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.

Primary Outcome Measures

Name	Time	Method
Pain scores of movement-evoked pain at postoperative 24 hours	up to 24 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.

Secondary Outcome Measures

Name	Time	Method
Pain scores of movement-evoked pain at postoperative 48 and 72 hours	From the date of the end of surgery until the date of 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.
Pain scores of pain at rest at 24, 48 and 72 hours postoperatively	From the date of the end of surgery until the date of 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.
The incidence of moderate-to-severe movement-evoked pain at 24, 48 and 72 hours postoperatively	From the date of the end of surgery until the date of 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.
The incidence of moderate-to-severe pain at rest at 24, 48, and 72 hours postoperatively	From the date of the end of surgery until the date of 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.
The cumulative morphine consumption at 24, 48, and 72 hours postoperatively	From the date of the end of surgery until the date of 72 hours postoperatively	postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator
Time of Bowel function recovery	At 3 days after surgery	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
The incidence of postoperative nausea and vomiting during the first 72 hours postoperatively (any nausea or vomiting);	From the date of the end of surgery until the date of 72 hours postoperatively	we considered it PONV if patients felt any nausea or had any vomiting
The incidence of a composite of postoperative pulmonary complications during hospitalisation	during the period from the end of surgery to discharge, an average of 7 days	defined as positive if any component developed before discharge after surgery;
Length of hospital stay	during the period from the end of surgery to discharge, an average of 7 days	Length of hospital stay
Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery	From the date of the end of surgery until the date of 72 hours postoperatively	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).
Incidence of lidocaine toxicity	From the time of anesthesia induction until the date of 72 hours postoperatively	such as new onset electrocardiogram (ECG) irregularities, drowsiness, light-headedness, metallic taste, peri-oral numbness, and tinnitus
plasma lidocaine concentration	From the time of anesthesia induction until the date of 24hours postoperatively	Blood samples will be collected from some patients in the lidocaine group measurement of lidocaine plasma concentration.

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China