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

Primary Purpose

Colorectal Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
lidocaine
Placebo
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China Hospital, Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain scores of movement-evoked pain at postoperative 24 hours
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
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
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
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
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
postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator
Time of Bowel function recovery
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);
we considered it PONV if patients felt any nausea or had any vomiting
The incidence of a composite of postoperative pulmonary complications during hospitalisation
defined as positive if any component developed before discharge after surgery;
Length of hospital stay
Length of hospital stay
Quality of Recovery Scale Score at 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).
Incidence of lidocaine toxicity
such as new onset electrocardiogram (ECG) irregularities, drowsiness, light-headedness, metallic taste, peri-oral numbness, and tinnitus
plasma lidocaine concentration
Blood samples will be collected from some patients in the lidocaine group measurement of lidocaine plasma concentration.

Full Information

First Posted
June 2, 2023
Last Updated
October 10, 2023
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05920980
Brief Title
Effect of Lidocaine on Postoperative Pain in Elderlypatients Undergoing Colorectal Cancer Surgery
Official Title
Effect of Perioperative Continuous Intravenous Infusion of Lidocaine on Postoperative Pain in Elderly Patients Undergoing Colorectal Cancer Surgery: a Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiming Li, PhD
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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