Skip to main content
OpenTrials
Completed

NCT Number: NCT05412576

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lidocaine Hydrochloride 2% Injection Solution

Drug

Injectable

Other names: IVL 0.5/1.0/1.5group

0.9% NaCl

Drug

Injectable

Other names: placebo group

Primary outcomes

  1. The incidence of moderate to severe pain (NRS score≥4)during movement (i.e.deep breathing) 24 hours after surgery

    Time frame: The first 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.

Secondary outcomes

  1. The blood concentration of lidocaine immediately and 24 hours after the operation

    Time frame: immediately after the operation; 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.

  2. 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

    Time frame: 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.

  3. Incidence of lidocaine toxicity within 72 hours after surgery

    Time frame: 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.

  4. Quality of Recovery Scale Score (QoR-15) at 24, 48, and 72 hours after surgery

    Time frame: 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).

  5. Bowel function recovery

    Time frame: From the end of surgery to discharge, up to 1 week

    defined as the time to first defecation or the time to first flatus

  6. Incidence of adverse reactions to opioids within three days after surgery

    Time frame: within three days after surgery

    It is defined as if patients happened any constipation, nausea, vomiting, drowsiness, dizziness, itchy skin, confusion, respiratory depression, etc.

  7. The incidence of a composite of postoperative pulmonary complications during hospitalization

    Time frame: from the end of surgery to discharge, up to 1 week

    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

  8. Length of hospital stay

    Time frame: from the end of surgery to discharge, up to 1 month.

    determined by the number of days from admittance to discharge

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2022
Registry last updated
Mar 13, 2024

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.

Published trials that share one or more normalized conditions with this study.