Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Pancreatic Neoplasms

Postoperative Complications

Pain, Postoperative

Pain

Neurologic Manifestations

Pancreatic Cancer

Patients randomized to recieve epidural catheter placement with LOS technique, without any Rx control

Patients randomized for X-ray placement of epidural catheter

placement of epidural catheters with LOS technique

placement of epidural catheters with x-ray guide

X-ray placement

Alvise Martini, MD

The use of epidural catheters for postoperative analgesia in pancreatic surgery is recommended by the guidelines of the ERAS society. Some studies claim it may expose to hemodynamic alterations that may compromise outcome and increase postoperative complications, attributable to a malfunction of the catheter itself, often linked to a bad positioning, since this is usually positioned with LOS technique. Our hypothesis is that a positioning made using the radiographic guide the day before the intervention can significantly reduce the number of catheter's dysfunctions.

About 30% of epidural catheters are reported to have hypo or hyper functioning behaviour. This has and impact on postoperative pain control and can affect also surgical and global outcome since it is known that a malfunctional catheter carries an increased complication's rate.

Our hypothesis is that rx-guided positioning can reduce the incidence of catheter malfunction afrom 30 to 15 %.

PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique

PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique: Outcome Influence on Patient Underwent Pancreatic Surgery

malfunctional catheters are defined as following:

* symptomatic hypotension due to epidural infusion
* NRS \> 6 in the first postoperative day and NRS \> 4 in subsequent postoperative day
* overt malpositioning:
* rx evidence of catheter's tip under T10 during routine rx or TC
* NRS \> 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and response to lidocaine 1% 6ml bolus (low tip)
* NRS \> 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and NO response to lidocaine 1% 6ml bolus ( not in epidural space or very low tip)
* evidence of catheter accidental removal

Numerical Rating Scale (NRS) is used to assess pain. Patients self-report actual pain on 0 to 10 scale where 0 is no pain and 10 is the worst immaginable pain.

Parameter used

-higher postoperative daily numeric rating scale (NRS) until catheter removal

Numerical Rating Scale (NRS) is used to assess pain. Patients self-report actual pain on 0 to 10 scale where 0 is no pain and 10 is the worst immaginable pain.

Complications are considered as:

* bleedings
* infections
* pancreatic fistulas (degree)
* biliary fistulas
* abdominal collections
* ICU admission
* needs of new surgery (for any reasons)
* pneumonia
* delayed gastric emptying

Azienda Ospedaliera Universitaria Integrata Verona

MD, Principal Investigator

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

NaCl 0.9% continous intravenous on general anesthesia during tumor craniotomy surgery

Adjuvant lidocaine continous intravenous on general anesthesia during tumor craniotomy surgery

NaCl 0.9% continous intravenous on tumor craniotomy surgery

NaCl 0.9%

Adjuvant lidocaine continous intravenous on tumor craniotomy surgery

Adjuvant lidocaine continous

Arief Cahyadi, Specialist

This study aims to investigate the effect of adjuvant continuous lidocaine in General Anesthesia on Depth of Anesthesia (qCON), Pain Response (qNOX), and Blood Sugar Levels in Elective Primary Tumor Craniotomy Surgery

Craniotomy for resection of brain tumors is frequently performed in neurosurgical practice. Craniotomy surgery is currently starting to use the Enhanced Recovery After Surgery (ERAS) protocol, namely for intraoperative pain management. Intraoperative pain can be evaluated through intraoperative hemodynamic conditions or can also use qCON and qNOX parameters and blood sugar levels. Perioperative pain management in the form of continuous intravenous lidocaine shows a role in reducing intraoperative pain. However, the use of intravenous lidocaine in ERAS protocols is still debated. So this study aims to use general anesthesia with continuous IV lidocaine adjuvant general anesthesia to affect depth of anesthesia (qCONtm) and intraoperative pain response in the form of values (qNOXtm), and blood sugar levels during elective primary tumor craniotomy.

The method is a Double-Blinded Randomized Control Trial. 60 patients aged 18-65 years who were diagnosed with craniotomy supratentorial tumor were randomly allocated to either Adjuvant Continuous Lidocaine (intervention group) or Normal Saline 0.9% (control group). Both drugs are given in a 20 ml syringe. The primary outcome measure of the study was the intraoperative of qCON, qNOX, and Blood Sugar. While the secondary outcome was the intraoperative hemodynamic.

All patients will be induced by general anesthesia using fentanyl 3 μg/kg IV as coinduction and propofol 1 mg/kg until the patient falls asleep. After induction, patients who receive lidocaine will receive a continuous intravenous infusion of 2 mg/kg/hour of lidocaine while other patients are given 0.9% NaCl as control. All patients data of hemodynamics, qCon, QNox, and blood glucose recorded and will be analyze.

Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery

Effectiveness of Adjuvant Continuous Lidocaine in General Anesthesia on Depth of Anesthesia (qCON), Pain Response (qNOX), and Blood Sugar Levels in Elective Primary Tumor Craniotomy Surgery

Depth of Anaesthesia measured by qCON index on CONOX monitor. qCON ranges from 0 to 99. A qCON index of more than 60 indicates inadequate use of sedative agents, whereas a qCON of less than 40 indicates excessive sedation

Pain Response measured by qNOX index on CONOX monitor. The qNOX index uses a scale from 0 to 99 where 99 indicates a high probability of response to noxious stimulation. A decreasing index value means a smaller probability of response to the stimulus

Blood Sugar Levels measured by blood test during surgery

blood pressure (mm/Hg) shown on the monitor during surgery, induction, intubation, head pin installation, and skin incision, bone opening, dura mater opening, skin suturing. Blood Preasure includes systolic (mmHg), Diastolic (mmHg), and Mean Arterial Pressure (mmHg)

Heart Rate (times/minutes) shown on the monitor during surgery, induction, intubation, head pin installation, and skin incision, bone opening, dura mater opening, skin suturing

Body Temperature (celsius) shown on the monitor during surgery, induction, intubation, head pin installation, and skin incision, bone opening, dura mater opening, skin suturing

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique	NCT03685370	Postoperative P... Postoperative C... Pancreatic Canc... Haemodynamic In...	LOS X-ray placement	18 Years - 80 Years	Azienda Ospedaliera Universitaria Integrata Verona
Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery	NCT06249113	Surgery Anesthesia; Fun... Haemodynamic In...	NaCl 0.9% Adjuvant lidoca...	18 Years - 65 Years	Indonesia University
PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique	NCT03685370	Postoperative P... Postoperative C... Pancreatic Canc... Haemodynamic In...	LOS X-ray placement	18 Years - 80 Years	Azienda Ospedaliera Universitaria Integrata Verona

Spots Global Cancer Trial Database for haemodynamic instability