Colorectal CancerNCT05920980
Effect of Lidocaine on Postoperative Pain in Elderlypatients Undergoing Colorectal Cancer Surgery
A study testing lidocaine in people with Colorectal Cancer, run by West China Hospital at 1 site in China.
Trial summary
Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2023to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- lidocaine, Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
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.
PlaceboDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Experimental | 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. Receives: Drug: lidocaine |
| Placebo group | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 hours postoperatively
Secondary outcomes (12)
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.
Measured: From the date of the end of surgery until the date of 72 hours postoperatively
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.
Measured: From the date of the end of surgery until the date of 72 hours postoperatively
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.
Measured: From the date of the end of surgery until the date of 72 hours postoperatively
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.
Measured: From the date of the end of surgery until the date of 72 hours postoperatively
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
Measured: From the date of the end of surgery until the date of 72 hours postoperatively
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
Measured: At 3 days after surgery
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
Measured: From the date of the end of surgery until the date of 72 hours postoperatively
The incidence of a composite of postoperative pulmonary complications during hospitalisation
defined as positive if any component developed before discharge after surgery;
Measured: during the period from the end of surgery to discharge, an average of 7 days
Length of hospital stay
Length of hospital stay
Measured: during the period from the end of surgery to discharge, an average of 7 days
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).
Measured: From the date of the end of surgery until the date of 72 hours postoperatively
Incidence of lidocaine toxicity
such as new onset electrocardiogram (ECG) irregularities, drowsiness, light-headedness, metallic taste, peri-oral numbness, and tinnitus
Measured: From the time of anesthesia induction until the date of 72 hours postoperatively
plasma lidocaine concentration
Blood samples will be collected from some patients in the lidocaine group measurement of lidocaine plasma concentration.
Measured: From the time of anesthesia induction until the date of 24hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start5 Jun 2023
- Primary completion13 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Weiming Li, PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920980
- Sponsor's protocol ID
- 2020HX1180
- Status last verified
- Feb 2025
- First submitted
- 2 Jun 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05920980
- Acronym / sponsor ID
- 2020HX1180
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: lidocainePatients 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 group | Placebo comparator | Drug: PlaceboIn 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 may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocainePatients 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 group |
| PlaceboAlso: placebo groupIn 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 group |
Primary outcome
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.
12 secondary outcomes
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
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 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 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 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
Time of Bowel function recovery
Time frame: At 3 days after surgery
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
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
Length of hospital stay
Time frame: during the period from the end of surgery to discharge, an average of 7 days
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
Incidence of lidocaine toxicity
Time frame: From the time of anesthesia induction until the date of 72 hours postoperatively
plasma lidocaine concentration
Time frame: From the time of anesthesia induction until the date of 24hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiming Li, PhD principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine in people with Colorectal Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores of movement-evoked pain at postoperative 24 hours (time frame: up to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.