ERASERASNCT05470166
Lidocaine Infusion With ERAS Protocol for Pancreatic Cancer Surgery: Effect on Pain and Patient Immunity.
A study testing Lidocaine IV and saline IV in people with ERAS and Lidocaine, run by Alexandria University at 1 site in Egypt.
Trial summary
The whole world now is directed to implement strategies that enhance the patient's quality of life and prevent tumor relapse. Enhanced recovery after pancreatic surgery (ERAPS) program was found to improve the quality of life as it is an evidence-based protocol designed to standardize and optimize perioperative… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- ERAS, Lidocaine, Cancer of Pancreas
- What is being tested?
- Lidocaine IV and saline IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2022to 1 Apr 2024
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-70 years
- Both sex.
- American society of anesthesiology (ASA) physical status class II;III.
- Resectable pancreatic tumors.
Who cannot join
- Patients with history of sensitivity to lidocaine,
- Diabetic patients.
- Body weight loss > 15%.
- Opioid tolerant patient or patient receiving nonsteroidal anti-inflammatory drugs within 1 week of surgery or antiarrythmic drugs.
- Cognitive dysfunction.
- Any history of antitumor treatments or chemotherapy before surgery
- Any contraindication for neuraxial anaesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine Infusion With Enhanced Recovery Program for Pancreatic Cancer Surgery: Effect on Pain and Patient Immunity
The whole world now is directed to implement strategies that enhance the patient's quality of life and prevent tumor relapse.
Enhanced recovery after pancreatic surgery (ERAPS) program was found to improve the quality of life as it is an evidence-based protocol designed to standardize and optimize perioperative medical care in order to reduce surgical trauma, perioperative physiological stress, organ dysfunction, reduction of clinical complications, length of hospital stay and the health costs together with increase of patient satisfaction.
Read more
lidocaine; it is an amide local anaesthetic Recently its use as intravenous perioperative infusion for abdominal cancer surgeries is encouraging, as it significantly reduces postoperative pain, opioid consumption and nausea and vomiting. it also promotes gastrointestinal function recovery, and shortens the postoperative hospital stay. In addition, lidocaine in particular can act directly and indirectly on pancreatic cancer cells and the tumor microenvironment.
The investigators suggest that IV lidocaine infusion in combination with ERAPS protocol may achieve better postoperative outcomes after pancreatic surgery for cancer.
Read the detailed description
The whole world now is directed to implement strategies that enhance the patient's quality of life and prevent tumor relapse , so the Enhanced recovery after pancreatic surgery (ERAPS) program was found to improve the quality of life as it is an evidence-based protocol designed to standardize and optimize perioperative medical care in order to reduce surgical trauma, perioperative physiological stress, organ dysfunction, reduction of clinical complications, length of hospital stay and the health costs together with increase of patient satisfaction.
ERAPS was applied for pancreatic surgery in 2012, since that time 27 developed ERAPS items were evaluated, 5 of them got the highest level of evidence those include (avoiding hypothermia, use of wound catheters for continuous analgesia, antimicrobial, thromboprophylaxis protocols and preoperative nutritional interventions for patients with severe weight loss (15%). ERAS society encourages further researches to improve compliance and outcome and to confirm the benefit of current updated recommendations.
Many drugs had been used in the anaesthetic management of major abdominal surgeries and of which is lidocaine; it is an amide local anaesthetic commonly used for regional and neuraxial blocks. Recently its use as intravenous perioperative infusion for abdominal cancer surgeries is encouraging, as it significantly reduces postoperative pain, opioid consumption and nausea and vomiting. it also promotes gastrointestinal function recovery, and shortens the postoperative hospital stay.
In addition, lidocaine in particular can act directly and indirectly on pancreatic cancer cells and the tumor microenvironment. At the tumor level, lidocaine can induce apoptosis in cancer cells by inhibiting Src phosphorylation and reducing the expression of adhesion molecules. In the tumor microenvironment, lidocaine can enhance the activity of immune cells such as natural killer cells, which are responsible for directly attacking cancer cells. Furthermore the impact of lidocaine on post-operative opioid consumption could be another factor that reduces the opioid associated cancer progression.
Natural killer (NK) cells are cluster of differentiation 3 (CD3-) -cluster of differentiation 56 (CD56+) lymphocytes playing a pivotal role in the innate immune response against cancer. Their main purpose is identification and eradication of virus infected cells and metastatic cells. Diminished activity of NK cells is a predisposing factor for cancer recurrence. Preservation of innate immune function and the direct anti-inflammatory effects may be the cause of the protective effects of local anaesthetics and regional techniques.
Different concentrations of local anaesthetics appear to have different effects on NK cytotoxicity. High concentrations of lidocaine suppress NK cell cytotoxicity; yet clinically relevant concentrations enhance the in vitro function of NK cells via the release of lytic granules. Hence, lidocaine appears to have predominantly anticancer effects So the investigators suggest that IV lidocaine infusion in combination with ERAPS protocol may achieve better postoperative outcomes after pancreatic surgery for cancer.
- Being tested
- Lidocaine IV, saline IV
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IVDrug
lidocaine infusion as bolus 1.5mg/kg then 2mg/kg/hr
saline IVOther
saline infusion same volume as lidocaine
| Study group | Role | What they receive |
|---|---|---|
| infusion of intraoperative lidocaine to patients undergoing whipple surgery | Experimental | lidocaine 1.5mg/kg infused as bolus, then 2mg/kg/hr through the operation Receives: Drug: Lidocaine IV |
| saline infusion of same volume of lidocaine | Experimental | same amount of normal saline infused as bolus and infusion Receives: Other: saline IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative nociceptive pain assessment.
post operative pain assessment using visual analogue scale (VAS), The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be.
Measured: 24 hours postoperative
Secondary outcomes (10)
Effect on immune response
Natural killer cell isolation will be done preoperatively and 5 days postoperative
Measured: pre-operative and 5 days postoperative
Effect on i tumor recurrence
cytotoxic lymphocytes assay will be measured preoperatively and 5 days postoperative
Measured: pre-operative and 5 days postoperative
Total intra-operative fluid requirements.
Total intraoperative fluid requirements in liters and fluid responsiveness assessed by pleth variability index (PVI) every 10 minutes to keep value < 13 %.
Measured: intra-operative every 10 minutes
Gastro-intestinal recovery.
effect of lidocaine on enhancing gastrointestinal motility,Time to return of bowel sounds in hours, first time to pass flatus and time to first defecation in hours will be recorded.
Measured: up to 5 days postoperative
Time to first ambulation
effect of lidocaine and epidural analgesia on pain
Measured: up to 5 days post-operative
Total analgesic consumption
effect of lidocaine on analgesic requirements
Measured: up to 5 days post-operative
Length of hospital stay in days
effect of lidocaine on ERAS and Duration of hospital stay in days will be recorded in both groups including the start of the hospitalization time
Measured: up to 5 days postoperative
Effect on haemodynamics
effect of lidocaine on heart rate in beats per minute
Measured: intraoperative and 5 days post-operative
Effect on haemodynamics
effect of lidocaine on blood pressure in mmHg
Measured: intraoperative and 5 days post-operative
Perioperative complications
recording of any complications perioperatively and postoperatively Nausea and vomiting, wound infection, urinary tract infection, deep vein thrombosis and hematoma will be recorded in both groups.
Measured: intraoperative and up to 5 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start20 Apr 2022
- Primary completion17 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alexandria
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470166
- Sponsor's protocol ID
- lidocaine ERAS whipple
- Acronym
- ERAS
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: through clinical trials
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Infusion With Enhanced Recovery Program for Pancreatic Cancer Surgery: Effect on Pain and Patient Immunity
- ClinicalTrials.gov ID
- NCT05470166
- Acronym / sponsor ID
- ERAS / lidocaine ERAS whipple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- University of Alexandria
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 22 Jul 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.
The whole world now is directed to implement strategies that enhance the patient's quality of life and prevent tumor relapse.
Enhanced recovery after pancreatic surgery (ERAPS) program was found to improve the quality of life as it is an evidence-based protocol designed to standardize and optimize perioperative medical care in order to reduce surgical trauma, perioperative physiological stress, organ dysfunction, reduction of clinical complications, length of hospital stay and the health costs together with increase of patient satisfaction.
lidocaine; it is an amide local anaesthetic Recently its use as intravenous perioperative infusion for abdominal cancer surgeries is encouraging, as it significantly reduces postoperative pain, opioid consumption and nausea and vomiting. it also promotes gastrointestinal function recovery, and shortens the postoperative hospital stay. In addition, lidocaine in particular can act directly and indirectly on pancreatic cancer cells and the tumor microenvironment.
The investigators suggest that IV lidocaine infusion in combination with ERAPS protocol may achieve better postoperative outcomes after pancreatic surgery for cancer.
Detailed description
The whole world now is directed to implement strategies that enhance the patient's quality of life and prevent tumor relapse , so the Enhanced recovery after pancreatic surgery (ERAPS) program was found to improve the quality of life as it is an evidence-based protocol designed to standardize and optimize perioperative medical care in order to reduce surgical trauma, perioperative physiological stress, organ dysfunction, reduction of clinical complications, length of hospital stay and the health costs together with increase of patient satisfaction.
ERAPS was applied for pancreatic surgery in 2012, since that time 27 developed ERAPS items were evaluated, 5 of them got the highest level of evidence those include (avoiding hypothermia, use of wound catheters for continuous analgesia, antimicrobial, thromboprophylaxis protocols and preoperative nutritional interventions for patients with severe weight loss (15%). ERAS society encourages further researches to improve compliance and outcome and to confirm the benefit of current updated recommendations.
Many drugs had been used in the anaesthetic management of major abdominal surgeries and of which is lidocaine; it is an amide local anaesthetic commonly used for regional and neuraxial blocks. Recently its use as intravenous perioperative infusion for abdominal cancer surgeries is encouraging, as it significantly reduces postoperative pain, opioid consumption and nausea and vomiting. it also promotes gastrointestinal function recovery, and shortens the postoperative hospital stay.
In addition, lidocaine in particular can act directly and indirectly on pancreatic cancer cells and the tumor microenvironment. At the tumor level, lidocaine can induce apoptosis in cancer cells by inhibiting Src phosphorylation and reducing the expression of adhesion molecules. In the tumor microenvironment, lidocaine can enhance the activity of immune cells such as natural killer cells, which are responsible for directly attacking cancer cells. Furthermore the impact of lidocaine on post-operative opioid consumption could be another factor that reduces the opioid associated cancer progression.
Natural killer (NK) cells are cluster of differentiation 3 (CD3-) -cluster of differentiation 56 (CD56+) lymphocytes playing a pivotal role in the innate immune response against cancer. Their main purpose is identification and eradication of virus infected cells and metastatic cells. Diminished activity of NK cells is a predisposing factor for cancer recurrence. Preservation of innate immune function and the direct anti-inflammatory effects may be the cause of the protective effects of local anaesthetics and regional techniques.
Different concentrations of local anaesthetics appear to have different effects on NK cytotoxicity. High concentrations of lidocaine suppress NK cell cytotoxicity; yet clinically relevant concentrations enhance the in vitro function of NK cells via the release of lytic granules. Hence, lidocaine appears to have predominantly anticancer effects So the investigators suggest that IV lidocaine infusion in combination with ERAPS protocol may achieve better postoperative outcomes after pancreatic surgery for cancer.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infusion of intraoperative lidocaine to patients undergoing whipple surgery | Experimental | Drug: Lidocaine IVlidocaine 1.5mg/kg infused as bolus, then 2mg/kg/hr through the operation |
| saline infusion of same volume of lidocaine | Experimental | Other: saline IVsame amount of normal saline infused as bolus and infusion |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30-70 years
- Both sex.
- American society of anesthesiology (ASA) physical status class II;III.
- Resectable pancreatic tumors.
Key exclusion criteria (7 listed)
- Patients with history of sensitivity to lidocaine,
- Diabetic patients.
- Body weight loss > 15%.
- Opioid tolerant patient or patient receiving nonsteroidal anti-inflammatory drugs within 1 week of surgery or antiarrythmic drugs.
- Cognitive dysfunction.
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 IVlidocaine infusion as bolus 1.5mg/kg then 2mg/kg/hr | Drug | infusion of intraoperative lidocaine to patients undergoing whipple surgery |
| saline IVsaline infusion same volume as lidocaine | Other | saline infusion of same volume of lidocaine |
Primary outcome
Post-operative nociceptive pain assessment.
Time frame: 24 hours postoperative
post operative pain assessment using visual analogue scale (VAS), The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be.
10 secondary outcomes
Effect on immune response
Time frame: pre-operative and 5 days postoperative
Effect on i tumor recurrence
Time frame: pre-operative and 5 days postoperative
Total intra-operative fluid requirements.
Time frame: intra-operative every 10 minutes
Gastro-intestinal recovery.
Time frame: up to 5 days postoperative
Time to first ambulation
Time frame: up to 5 days post-operative
Total analgesic consumption
Time frame: up to 5 days post-operative
Length of hospital stay in days
Time frame: up to 5 days postoperative
Effect on haemodynamics
Time frame: intraoperative and 5 days post-operative
Effect on haemodynamics
Time frame: intraoperative and 5 days post-operative
Perioperative complications
Time frame: intraoperative and up to 5 days postoperative
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 21 Aug 2024.
- Individual participant dataSharing planned: Yes. through clinical trials
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 IV and saline IV in people with ERAS and Lidocaine, run by Alexandria University at 1 site in Egypt.
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 21 Aug 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 Egypt. 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. 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?
Post-operative nociceptive pain assessment. (time frame: 24 hours postoperative). 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 21 Aug 2024.