Colorectal Cancer
Conditions
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.
Interventions
DRUGlidocaine
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.
DRUGPlacebo
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.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding of research personnel and patients will be maintained throughout the observation period. On the day of surgery, nurses who did not participate in the perioperative management will assign the standard configuration of the trial drugs, including intraoperative medication and the configuration of the postoperative analgesic pump, to the researchers before the induction of anesthesia. Throughout the study, the patients and researchers should not be unblinded until the statistical analysis of the study data is completed. During the operation, an independent anesthesiologist will be responsible for the blood draw, and the postoperative blood samples will be collected together with the routine blood examination specimens. The investigators remained blinded throughout the observation period until the anesthesiologist or assessors observe significant adverse events of local general anesthesia toxicity.
Intervention model description
Patients were randomized in a 1:1 lidocaine group, placebo control group using a computer-generated random number table. After the randomization scheme is written, use the opaque envelope, hide each group envelope into an opaque envelope, the envelope outside the code, is sealed to the researcher, when the study, if the inclusion criteria, then open the corresponding numbered envelope, and intervene according to the group scheme in the envelope.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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 |
Countries
China
Outcome results
None listed