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NCT Number: NCT05920980

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

Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants were at least 60 years old;
  • American Society of Anesthesiologists (ASA) physical status I to III;
  • Body-mass index of 18-30 kg/m2;
  • Scheduled for elective colorectal surgery.

Exclusion criteria

  • Metastases occurring in other distant organs;
  • Severe hepatic insufficiency (aspartate aminotransferase or alanine transaminase or bilirubin >2.5 times the upper limit of normal);
  • Renal impairment (creatinine clearance <60 mL/min);
  • Cardiac rhythm disorders or systolic heart failure (second-and third-degree heart block, ejection fraction <50%);
  • Allergies to any of the trial drugs; chronic opioid use;
  • Inability to comprehend numeric rating scale.

Treatment and study plan

Lidocaine

Drug

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

Drug

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.

Other names: placebo group

Primary outcomes

  1. Pain scores of movement-evoked pain at postoperative 24 hours

    Time frame: 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 outcomes

  1. Pain scores of movement-evoked pain at postoperative 48 and 72 hours

    Time frame: 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.

  2. Pain scores of pain at rest at 24, 48 and 72 hours postoperatively

    Time frame: 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.

  3. The incidence of moderate-to-severe movement-evoked pain at 24, 48 and 72 hours postoperatively

    Time frame: 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.

  4. The incidence of moderate-to-severe pain at rest at 24, 48, and 72 hours postoperatively

    Time frame: 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.

  5. The cumulative morphine consumption at 24, 48, and 72 hours postoperatively

    Time frame: 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

  6. Time of Bowel function recovery

    Time frame: 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

  7. The incidence of postoperative nausea and vomiting during the first 72 hours postoperatively (any nausea or vomiting);

    Time frame: 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

  8. The incidence of a composite of postoperative pulmonary complications during hospitalisation

    Time frame: 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;

  9. Length of hospital stay

    Time frame: during the period from the end of surgery to discharge, an average of 7 days

    Length of hospital stay

  10. Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery

    Time frame: 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).

  11. Incidence of lidocaine toxicity

    Time frame: 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

  12. plasma lidocaine concentration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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