Colorectal CancerNCT05412576
a Pilot Study of Lidocaine Infusion for Postoperative Analgesia in Elderly Patients With Colorectal Cancer Surgery
A study testing Lidocaine Hydrochloride 2% Injection Solution and 0.9% NaCl 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 1:1:1:1 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… 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 Hydrochloride 2% Injection Solution and 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 25 Dec 2022
- 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
- Age over 60 years old；
- American Society Anesthesiologygist(ASA)I~III；
- Patients scheduled for colorectal cancer surgery；
- The surgery takes more than two hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- Lidocaine Hydrochloride 2% Injection Solution, 0.9% NaCl
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Hydrochloride 2% Injection SolutionDrug
Also called IVL 0.5/1.0/1.5group
Injectable
0.9% NaClDrug
Also called placebo group
Injectable
| Study group | Role | What they receive |
|---|---|---|
| IVL0.5 group | Experimental | At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure. Receives: Drug: Lidocaine Hydrochloride 2% Injection Solution |
| IVL1.0 group | Experimental | At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure. Receives: Drug: Lidocaine Hydrochloride 2% Injection Solution |
| IVL1.5 group | Experimental | At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure. Receives: Drug: Lidocaine Hydrochloride 2% Injection Solution |
| Placebo group | Placebo comparator | At the beginning of surgery, in the placebo group, the same dose of normal saline as the experimental groups will be given until the procedure is over. Receives: Drug: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of moderate to severe pain (NRS score≥4）during movement (i.e.deep breathing) 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.
Measured: The first 24 hours after surgery
Secondary outcomes (8)
The blood concentration of lidocaine immediately and 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.
Measured: immediately after the operation; 24 hours after the operation
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
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.
Measured: 24 hours after surgery at rest; 48 and 72 hours after surgery, both at rest and during movement
Incidence of lidocaine toxicity 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.
Measured: within 72 hours after surgery
Quality of Recovery Scale Score (QoR-15) 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: 24, 48, and 72 hours after surgery
Bowel function recovery
defined as the time to first defecation or the time to first flatus
Measured: From the end of surgery to discharge, up to 1 week
Incidence of adverse reactions to opioids within three days after surgery
It is defined as if patients happened any constipation, nausea, vomiting, drowsiness, dizziness, itchy skin, confusion, respiratory depression, etc.
Measured: within three days after surgery
The incidence of a composite of postoperative pulmonary complications during hospitalization
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
Measured: from the end of surgery to discharge, up to 1 week
Length of hospital stay
determined by the number of days from admittance to discharge
Measured: from the end of surgery to discharge, up to 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jun 2021
- Primary completion24 Oct 2022
- Study completion25 Dec 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 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
- Jiang Chunling, PhD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412576
- Sponsor's protocol ID
- 2020-1180
- Status last verified
- Mar 2024
- First submitted
- 25 May 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05412576
- Acronym / sponsor ID
- 2020-1180
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 9 Jun 2022 (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 1:1:1:1 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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IVL0.5 group | Experimental | Drug: Lidocaine Hydrochloride 2% Injection SolutionAt the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure. |
| IVL1.0 group | Experimental | Drug: Lidocaine Hydrochloride 2% Injection SolutionAt the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure. |
| IVL1.5 group | Experimental | Drug: Lidocaine Hydrochloride 2% Injection SolutionAt the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure. |
| Placebo group | Placebo comparator | Drug: 0.9% NaClAt the beginning of surgery, in the placebo group, the same dose of normal saline as the experimental groups will be given until the procedure is over. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 60 years old；
- American Society Anesthesiologygist(ASA)I~III；
- Patients scheduled for colorectal cancer surgery；
- The surgery takes more than two hours
Key exclusion criteria (7 listed)
- 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.)；
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 |
|---|---|---|
| Lidocaine Hydrochloride 2% Injection SolutionAlso: IVL 0.5/1.0/1.5groupInjectable | Drug | IVL0.5 group, IVL1.0 group, IVL1.5 group |
| 0.9% NaClAlso: placebo groupInjectable | Drug | Placebo group |
Primary outcome
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.
8 secondary outcomes
The blood concentration of lidocaine immediately and 24 hours after the operation
Time frame: immediately after the operation; 24 hours after the operation
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
Incidence of lidocaine toxicity within 72 hours after surgery
Time frame: within 72 hours after surgery
Quality of Recovery Scale Score (QoR-15) at 24, 48, and 72 hours after surgery
Time frame: 24, 48, and 72 hours after surgery
Bowel function recovery
Time frame: From the end of surgery to discharge, up to 1 week
Incidence of adverse reactions to opioids within three days after surgery
Time frame: within three days after surgery
The incidence of a composite of postoperative pulmonary complications during hospitalization
Time frame: from the end of surgery to discharge, up to 1 week
Length of hospital stay
Time frame: from the end of surgery to discharge, up to 1 month.
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 13 Mar 2024.
- 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.
Jiang Chunling, PhD study director
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 Hydrochloride 2% Injection Solution and 0.9% NaCl 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 7 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 13 Mar 2024. 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?
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). 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 13 Mar 2024.