Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Behaviors and Mental Disorders

Pancreatic Neoplasms

Liver Neoplasms

Pain

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Liver Diseases

Pancreatic Cancer

Quality of Life

Hematinics

All Drugs and Chemicals

Gastrointestinal Agents

Herbal and Botanical

Liver Extracts

Pancrelipase

Pancreatin

Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.

Intravenous Patient-Controlled Analgesia (IVPCA)

Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.

Thoracic Epidural Analgesia (TEA)

Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Questionnaires

Hourly post surgery rating level of pain on a scale of 0-10.

Pain Assessment

Jean-Nicolas Vauthey, MD

The goal of this clinical research study is to learn if there is a difference in patients' quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after surgery on the liver and/or pancreas. Researchers want to learn which method helps people to recover more completely and more quickly after surgery.

The 2 kinds of pain control are intravenous (IV) pain management and epidural pain management.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. For every participant assigned to Group 1, 3 participants will be assigned to Group 2. This means you are 3 times more likely to be assigned to Group 2 than you are to Group 1.

* Group 1 will receive IV pain management.
* Group 2 will receive epidural pain management.

Group 1:

IV pain management will be given through a needle in your arm. This needle will be placed when you are either in the holding area or in the operating room. You will have this needle placed no matter if you take part in this study or not. The needle is used to give drugs and manage fluids during surgery.

After surgery, your doctor will set the limit for the highest dose of pain medication that you can receive at any time, but you will be able to use a hand-held button to adjust your drug according to the level of pain you may be having.

If your pain is not well controlled, the study staff may decide you can be switched to Group 2 if it seems to be in your best interest.

Group 2:

Epidural pain management will be given through a needle inserted into the space between the covering of your spinal cord and the cord itself. This area is full of fluid and is called the epidural region. The needle will be placed before your surgery, either in the holding area or in the operating room by the doctor that gives your anesthesia.

If your epidural does not work, the study staff may decide you can be switched to Group 1 if it seems to be in your best interest.

Both Groups:

During your surgery, you will have a catheter (sterile flexible tube) placed in an artery. This catheter will be used to provide additional fluid and blood support and to monitor you during surgery. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.

During surgery, blood (about 1 tablespoon) will be drawn before you receive anesthesia. This blood will be drawn using one of the IV lines that you already have in place for your surgery. This blood will be tested to look for certain proteins called cytokines that may help researchers to understand how your body is responding to pain and how pain is affecting the healing process.

You will be asked to sign a separate consent form that describes the surgery and its risks in detail. The study staff will also tell you about the standard pain medications, how they will be given, and the possible risks.

After Surgery:

After your surgery, you will go to the Post-Anesthesia Care Unit (PACU) for recovery. You will have a physical exam to check your recovery. Your vital signs will also be measured. You will be asked how you are feeling. Your doctor(s) will decide whether you will go from the PACU to the intensive care unit (ICU), overnight recovery suite, or will be moved to a regular post-surgical recovery floor room, where your recovery will be watched.

On Days 1, 3, and 5 after your surgery, blood (about 1 tablespoon) will be drawn for cytokine testing. This blood will be drawn along with the other routine blood work that you will have after your surgery.

If you are in Group 2, a member of the MD Anderson Pain Service will check your epidural site every day to make sure that it is working and that there are no problems with the area around your epidural. A nurse will also check during each shift (about every 8-10 hours) to see how well you are able to move and how the epidural is affecting your feeling in the area it is supposed to be working in.

In both groups, you will be asked to rate your level of pain management on a scale of 0-10. When you first come out of surgery, this pain rating will happen about every hour. Your pain will also be rated about every hour if you are assigned to the surgical ICU. When you get to your room (overnight recovery or surgical floor), it will happen about every 4 hours. You can use your call bell to let a nurse know if your pain is intolerable between the nurses checks.

Questionnaires:

Before your surgery, you will fill out questionnaires about the pain and your quality of life. This should take about 20 minutes to complete.

From the day after surgery (Day 1) through Day 5, you will also be asked to fill out questionnaires about your recovery and any side effects and symptoms you may be having from the pain medication. This will take about 20-40 minutes.

While you are in the hospital, you will be asked to answer some questions that will measure how quickly you recover from the sedation used during your surgery. Each shift (about every 8-10 hours), a nurse will ask you questions to find out how quickly you are recovering from anesthesia.

Length of Study Participation:

The pain medication or epidural insertion will be stopped early if you are having intolerable side effects or if the medication is not working.

Your participation in the study will be over after Day 5.

This is an investigational study. IV pain management and epidural pain management are FDA approved and commercially available. Randomly assigning you to a type of pain management and comparing the treatments is being done for research purposes only.

Up to 200 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas

Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient Controlled Analgesia (3:1) in Patients Undergoing Liver and/or Pancreatic Resection

The Area Under the Curve (AUC) pain score during the first 48 hours after surgery. Post operative pain was measured during the first 48 hours per unit acuity guidelines. Typically this was at a minimum of every four hours yielding an average number of measures during the first 48 hours. The scale is 0-480 low scores are better.

M.D. Anderson Cancer Center

Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.

Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.

TEA (Thoracic Epidural Analgesia)

Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.

Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10.

IV-PCA (Intravenous Patient-controlled Analgesia)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Major hepatectomy

Dr. Jean-Nicolas Vauthey,MD/Professor, Surgical Oncology

Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.

Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10

Postoperative Pain Experience

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Inflammation

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

Sufentanil

Anesthetics

Bupivacaine

Ropivacaine

Morphine

Dsuvia

Anesthetics, Local

Analgesics, Opioid

Narcotics

Anesthetics, Intravenous

Anesthetics, General

TEA is used for perioperative pain management, having been used both intra- and postoperatively, up to 48 h.

PCA is the standard of pain management and is usually used for up to 48 h postoperative for pain management following radical prostatectomy.

Patient controlled analgesia (PCA)

Intra-operatively: Bupivacaine 0.5% with adrenaline Post-operatively: Ropivacaine 0.2% + sufentanil 1 ug

Anil Gupta, MD PhD

Several recently published retrospective studies show that regional anaesthesia (RA) can reduce cancer-related mortality following surgical treatment of colorectal, breast and prostate cancers and malignant melanoma. If these results are true, then the choice of perioperative pain management is as beneficial, or even better, than the current oncological therapies. This theory needs to be investigated in a prospective, randomized and controlled trail. We shall perform a prospective, randomized study comparing the effects of Thoracic epidural analgesia (TEA) or patient controlled analgesia (PCA) on postoperative immunological and inflammatory markers in order to understand whether the protective effects, if any, of regional analgesia are due to changes in these markers or whether the underlying mechanisms is not mediated via this stress signalling pathway.

Methods

Thirty patients (ASA status 1-2) in the age group 50 - 75 years, undergoing elective radical retropubic prostatectomy would be included in this pilot study. The exact type of cancer, its staging, degree of spread to proximal or distant sites and the pathologic type of cancer would be recorded. Patients on chronic analgesic medication, endocrinologic and immunologic diseases, those with known allergy to LA and those where epidural catheter placement was contraindicated would be excluded. Patients would be allocated to one of three groups: General anesthesia combined with Epidural anesthesia during and after the operation (Group GE; n = 12), General anesthesia combined with Epidural during anesthesia and local anesthesia postoperatively (Group GL; n = 12), General anesthesia alone (Group GO; n = 10)

Anesthesia and Surgery

All patients would be premedicated with midazolam 0.1 mg/kg 15-30 min before planned surgery, which is a routine in our hospital. Paracetamol 1 g was given orally every 6 h starting with the first dose at the time of premedication. IV access would be attained in the preoperative holding area and further anxiolytic would be given as necessary intravenously.

Epidural technique

In patients in Group GE, an 18 G epidural needle would be inserted at the Th10-12 inter-space using the 'hanging-drop' or loss of resistance technique with the patient in the sitting position in the holding area. The epidural catheter would be inserted and subsequently tested for subarachnoid or intravascular placement using 3 ml of mepivacaine 2% with adrenaline, which is standard practice in our hospital. A bolus dose of 3-4 ml mepivacaine 2% with adrenaline would subsequently be injected and a loss of sensation to cold determined after 10 min. If a sensory block to an upper level of Thoracic 8 dermatome and a minimal lower level of L2 is achieved, the patient would be considered to be ready for induction of anesthesia. If not, a further dose of 2-3 ml mepivacaine 2% with adrenaline would be injected epidurally. If this fails to achieve the desired block, it would be assumed that the catheter was incorrectly placed and the patient offered the choice of one more attempt at epidural catheter placement, or exclusion from the study.

Patients in Group GO would not have an epidural catheter placed. Following transfer to the operating room and routine monitoring, anesthesia would be induced in all patients with fentanyl 2 mg/kg i.v. and propofol 1-2mg/kg until loss of eyelash reflex. Tracheal intubation would be performed after muscle relaxation with rocuronium 0.5 mg/kg and anesthesia maintained with 1-3% sevoflurane and 33% oxygen in air. Mechanical ventilation would be used in a low-flow system in order to maintain an end-tidal CO2 of between 4.5-5.5 kPa. In all patients, sevoflurane concentration would be adjusted in order to maintain adequate anesthetic depth, which would be measured using Auditory evoked potentials (AEP) and maintained between 15-25 (A-line). Tachycardia, despite adequate anesthetic depth, would be treated by giving fentanyl intermittently IV as an analgesic when required during the operation. At the end of surgery, muscle relaxation would be reversed using glycopyrrolate (0.2 mg) and neostigmine (2.5 mg). Radical retropubic prostatectomy would be performed in a standardized way using a lower-abdominal midline incision.

Postoperative Management

During the first 4 h postoperatively, patients in Group GO would receive morphine 1-2 mg IV intermittently for pain relief in the post-anesthesia care unit (PACU) in order that the numeric rating scale (NRS) (0 = no pain, 10 = worst imaginable pain) is \< 3. Patients in Group GE would have an infusion of ropivacaine 0.2% 5-10 ml/h epidurally. In the event of pain, morphine (1-2 mg) would be administered intravenously as needed in both groups in order to provide good pain relief and NRS \< 3.

All patients would be observed in the PACU for 4 h before being transferred to the general urological ward. The epidural infusion/PCA pump would be continued as long as pain relief is needed using these techniques but for a minimum of 48 h. Subsequently, pain relief would be obtained using oral analgesics using a combination of paracetamol and NSAID drugs.

Recording and Measurements

The total amount of anesthetic and analgesic drugs required during the operation would be recorded. Anesthetic drug requirement would be determined by two methods: end-tidal concentration of sevoflurane recorded every 5 min and the weight of the vaporizer before and after each anesthetic. For all measurements, the time when the anesthetic gases were turned off was considered to be time zero (t = 0). In addition to the routine postoperative protocols, the following measurements were recorded:

Pain intensity: At the site of the incision, 'deep' (visceral) pain and pain on coughing at 1, 4, 12, 24 and 48 h was measured using the NRS.

Rescue analgesic (morphine) consumption: during 0-4 h, 4-24 h and 24-48 h. Supplementary analgesic consumption: Additional analgesics administered in order to relieve pain would be recorded/day.

Side effects: Nausea and/or vomiting (0-4 h, 4-24 h and 24-48 h), pruritus and all other complications were recorded.

Surgical complications: the surgical incision would be inspected daily for evidence of infection and graded as either no evidence of infection (= 0), evidence of inflammation (= 1), mild wound dehiscence or suspected infection (= 2) or pus formation with definite infection (= 3). After 48-72 h, the epidural catheter would be removed and the catheter tip sent for bacterial culture.

Blood sampling:

Patient serum or EDTA/Heparin plasma will be assessed for cytokine levels by a Luminex multiplex assay (Human Inflammation 12-Plex kit; GM.CSF, IFN-g, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, TNF-a and VEGF from R\&D system) and PGE2 levels will be measured by an ELISA kit from Cayman Chemicals Company. In addition, markers of systemic inflammatory response, including CRP, white blood cell count, differential count and total platelet count, will also be measured before and after surgery.

Natural Killer (NK) cell activity in the blood would be measured using the FANKIA assay. Clusters of differentiation (CD) markers would be measured.

Stress response would be measured using serum cortisol and prolactin levels.

Effects of Anesthetic Technique on Immune and Inflammatory Systems Following Radical Prostatectomy

Comparison Between Epidural and Patient Controlled Analgesia on Immunological and Inflammatory Systems Following Radical Retropubic Prostatectomy

NK cells are of primary importance in the elimination of tumor target cells at the early stage of tumor development, up to and including tumor metastasis. Decreased NK cell function during the perioperative period is associated with an increased risk of mortality in cancer patients. The NK cell activity would be measured using a special assay called FANKIA

Interleucine release is a response to injury and the amount of interleucine in the circulation is related to the degree of trauma. Intensity of trauma is in turn related to the degree of stress response, which is reduced by epidural analgesia

Serum cortisol is a marker for stress response which is an important factor in immune response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas	NCT01438476	Liver Cancer Pancreatic Canc...	Intravenous Pat... Thoracic Epidur... Questionnaires Pain Assessment	18 Years -	M.D. Anderson Cancer Center
Effects of Anesthetic Technique on Immune and Inflammatory Systems Following Radical Prostatectomy	NCT01367418	Prostate Cancer	Patient control... Thoracic Epidur...	50 Years - 78 Years	Örebro University, Sweden

Spots Global Cancer Trial Database for thoracic epidural analgesia (tea)