Effect of Lidocaine on Postoperative Pain in Elderlypatients Undergoing Colorectal Cancer Surgery
Study Details
Study Description
Brief Summary
Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lidocaine group 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. |
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 Comparator: Placebo group 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. |
Drug: 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants were at least 60 years old;
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American Society of Anesthesiologists (ASA) physical status I to III;
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Body-mass index of 18-30 kg/m2;
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Scheduled for elective colorectal surgery.
Exclusion Criteria:
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Metastases occurring in other distant organs;
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Severe hepatic insufficiency (aspartate aminotransferase or alanine transaminase or bilirubin >2.5 times the upper limit of normal);
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Renal impairment (creatinine clearance <60 mL/min);
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Cardiac rhythm disorders or systolic heart failure (second-and third-degree heart block, ejection fraction <50%);
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Allergies to any of the trial drugs; chronic opioid use;
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Inability to comprehend numeric rating scale.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West China Hospital, Sichuan University | Chengdu | Sichuan | China | 610041 |
Sponsors and Collaborators
- West China Hospital
Investigators
- Principal Investigator: Weiming Li, PhD, West China Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020HX1180