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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Alexandria university

    Alexandria

Other trials in Egypt

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 groups in NCT05470166
Study groupRoleWhat they receive
infusion of intraoperative lidocaine to patients undergoing whipple surgeryExperimentallidocaine 1.5mg/kg infused as bolus, then 2mg/kg/hr through the operation
Receives: Drug: Lidocaine IV
saline infusion of same volume of lidocaineExperimentalsame 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.

  1. 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)
  1. Effect on immune response

    Natural killer cell isolation will be done preoperatively and 5 days postoperative

    Measured: pre-operative and 5 days postoperative

  2. Effect on i tumor recurrence

    cytotoxic lymphocytes assay will be measured preoperatively and 5 days postoperative

    Measured: pre-operative and 5 days postoperative

  3. 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

  4. 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

  5. Time to first ambulation

    effect of lidocaine and epidural analgesia on pain

    Measured: up to 5 days post-operative

  6. Total analgesic consumption

    effect of lidocaine on analgesic requirements

    Measured: up to 5 days post-operative

  7. 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

  8. Effect on haemodynamics

    effect of lidocaine on heart rate in beats per minute

    Measured: intraoperative and 5 days post-operative

  9. Effect on haemodynamics

    effect of lidocaine on blood pressure in mmHg

    Measured: intraoperative and 5 days post-operative

  10. 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.

  1. First posted22 Jul 2022
  2. Study start20 Apr 2022
  3. Primary completion17 Jan 2024
  4. Study completion1 Apr 2024

Resources

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)
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

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.

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