Secondary Malignant Neoplasm of LiverNCT02647047
Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery
A study testing Spinal analgesia, Epidural analgesia and Transversus Abdominis Plane block in people with Secondary Malignant Neoplasm of Liver and Liver Diseases, run by Ospedale San Raffaele at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Malignant Neoplasm of Liver, Liver Diseases, Liver Neoplasms
- What is being tested?
- Spinal analgesia, Epidural analgesia and Transversus Abdominis Plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Hospitalized patients
- Surgical indication for minor laparotomic anterior liver resection (II, III, IV and V hepatic segment resection)
- Surgical indication for laparotomic liver metastasectomy
- Ability to provide an informed consent
Who cannot join
- Patient refusal to provide informed consent
- Chronical therapy with opioids
- Pregnancy or breastfeeding
- Alcohol or drug abuse
- Planned or unplanned post-operative intensive care unit admission
- Contraindication to spinal/epidural analgesia
Show all 9Show fewer
- Severe liver or renal failure
- Cognitive disorders, mental retard or psychiatric disorders
- Allergy to any drug used
Trial locations and contacts
1 site in 1 country.
Raffaella Reineke, M.D. contact
Italy1 site
Ospedale San Raffaele
Milan, MI, 20132
Elena Bignami, MD, +39.02.2643.4524, bignami.elena@hsr.it
About this study
Official title: Spinal Analgesia Versus Epidural Analgesia in Minor Laparotomic Liver Surgery in an Enhanced Recovery Programme: A Randomized Controlled Trial
The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient's length of hospitalization according to enhanced recovery after surgery (ERAS) principles.
Read the detailed description
Liver surgery is performed under general anesthesia. Loco-regional analgesia is generally performed before general anesthesia induction to obtain the best post-operative pain control,in association with intravenous analgesic drug administration.
For minor laparotomic surgery (defined as the resection of up to three hepatic segments), if not contraindicated, in our hospital loco-regional analgesia is performed through the placement of a thoracic (T7-T8 or T8-T9) epidural catheter in which a local anesthetic (usually ropivacaine) and an opioid (usually sufentanil) are administered for the first three post-operative days. This is still considered the gold-standard for pain management in this surgery. In our institute, there is a dedicated acute pain service (APS) for pain management in the post-operative period. APS is also responsible for monitoring, registering and treating all side effects related to both the procedure and the drugs used.
In laparoscopic abdominal surgery, instead of epidural analgesia, if not contraindicated, spinal analgesia with low dose morphine before general anesthesia induction is performed. This technique is actually considered efficacy and safe in these type of surgeries.
The investigators therefore decided to test the efficacy of spinal analgesia versus epidural analgesia for minor liver surgery since anterior hepatic segments resection is less painful than major liver surgery because it requires less liver manipulation without significant involvement of the Glisson's capsule. This might imply a less incidence of procedure-related side effects such as post-dural puncture headache or site infections. Moreover, spinal analgesia may allow a earlier post-operative patients mobilization and thus a earlier hospital discharge.
In this randomized controlled trial, the investigators therefore aim to randomize 40 consecutive patients into 2 arms. The experimental group will receive spinal analgesia (morphine 0.2 mg) for post-operative pain control while the control group will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2%: 99 mL + sufentanil 50 mcg/mL: 1 mL).
Randomization will be performed with closed opaque envelopes. During surgery, patients will be monitored as usual. Intraoperative blood losses and fluids administration will be recorded.
Patients randomized into the epidural group will not receive local anesthetic administration through the epidural catheter during the hepatic resection phase to avoid hemodynamic instability. Once the hepatic resection phase is finished and euvolemic status is recovered, epidural analgesia will be administered as mentioned before.
In patients in the spinal group, transversus abdominis plane (TAP) block with ropivacaine 0.375% 20 mL bilaterally or surgical wound infiltration with ropivacaine 0.75% 10- 20 mL will also be performed before anesthesia recovery.
In both groups, post-operative pain control will be managed with intravenous acetaminophen 1000 mg 40 minutes before ending of surgery followed by intravenous administration of acetaminophen 1000 mg every 8 hours and a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy in the post-operative period if not contraindicated.
Patients will be monitored every 24 hours until the achievement of the "ready to discharge" status defined as:
- appropriate oral alimentation;
- optimal pain control with drugs administered orally;
- adequate ability in walking and personal care;
- clinical, laboratory and instrumental absence of any post-operative complication;
- intestinal function recovery;
- patient consent to discharge.
- Being tested
- Spinal analgesia, Epidural analgesia, Transversus Abdominis Plane block, Surgical wound infiltration, Acetaminophen
- Keywords
- spinal analgesia, epidural analgesia, laparotomic liver resection, ERAS, length of stay
- Medical subject headings
- Liver Diseases, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal analgesiaProcedure or surgery
Administration of morphine 0.2 mg in subarachnoid space.
Epidural analgesiaProcedure or surgery
Bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL in epidural space
Transversus Abdominis Plane blockProcedure or surgery
Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally
Surgical wound infiltrationProcedure or surgery
Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL
AcetaminophenDrug
Administration of 1000 mg of acetaminophen 40 minutes before ending of surgery followed by intravenous administration of 1000 mg every 8 hours
KetorolacDrug
Administration of a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy
RopivacaineDrug
Epidural bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL
SufentanilDrug
Epidural continuous epidural infusion of sufentanil 50 mcg/mL 1 mL
RopivacaineDrug
Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally to obtain the transversus abdominis plane block
RopivacaineDrug
Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL
| Study group | Role | What they receive |
|---|---|---|
| Spinal | Experimental | Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection. Receives: Procedure: Spinal analgesia; Procedure: Transversus Abdominis Plane block; Procedure: Surgical wound infiltration; Drug: Acetaminophen; Drug: Ketorolac; Drug: Ropivacaine |
| Epidural | Active comparator | Patients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection. Receives: Procedure: Epidural analgesia; Drug: Acetaminophen; Drug: Ketorolac; Drug: Ropivacaine; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative pain control by mean of the visual analog scale early after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Measured: Within 1 hour after surgery
Assessment of postoperative pain control by mean of the visual analog scale six hours after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Measured: 6 hours after surgery
Assessment of postoperative pain control by mean of the visual analog scale one day after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Measured: 24 hours after surgery
Assessment of postoperative pain control by mean of the visual analog scale two days after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Measured: 48 hours after surgery
Assessment of postoperative pain control by mean of the visual analog scale three days after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Measured: 72 hours after surgery
Assessment of postoperative pain control by mean of the visual analog scale at hospital discharge
Visual analog scale (VAS) will be assessed and compared between the two groups.
Measured: Up to 30 days after surgery
Secondary outcomes (1)
Ready to discharge status
The postoperative day in which patients reach the "ready to discharge" status will be recorded and compared between the two groups.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Secondary Malignant Neoplasm of LiverStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Bignami, Ospedale San Raffaele
- Investigators
- Raffaella Reineke, M.D., Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647047
- Sponsor's protocol ID
- VAS-LIVER
- Status last verified
- Jan 2016
- First submitted
- 15 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tzimas P, Prout J, Papadopoulos G, Mallett SV. Epidural anaesthesia and analgesia for liver resection. Anaesthesia. 2013 Jun;68(6):628-35. doi: 10.1111/anae.12191.
PubMed 23662750Revie EJ, Massie LJ, McNally SJ, McKeown DW, Garden OJ, Wigmore SJ. Effectiveness of epidural analgesia following open liver resection. HPB (Oxford). 2011 Mar;13(3):206-11. doi: 10.1111/j.1477-2574.2010.00274.x.
PubMed 21309939Kasivisvanathan R, Abbassi-Ghadi N, Prout J, Clevenger B, Fusai GK, Mallett SV. A prospective cohort study of intrathecal versus epidural analgesia for patients undergoing hepatic resection. HPB (Oxford). 2014 Aug;16(8):768-75. doi: 10.1111/hpb.12222. Epub 2014 Jan 28.
PubMed 24467320Ntinas A, Kardassis D, Konstantinopoulos I, Kottos P, Manias A, Kyritsi M, Zilianiaki D, Vrochides D. Duration of the thoracic epidural catheter in a fast-track recovery protocol may decrease the length of stay after a major hepatectomy: a case control study. Int J Surg. 2013;11(9):882-5. doi: 10.1016/j.ijsu.2013.07.014. Epub 2013 Aug 4.
PubMed 23924906Koea JB, Young Y, Gunn K. Fast track liver resection: the effect of a comprehensive care package and analgesia with single dose intrathecal morphine with gabapentin or continuous epidural analgesia. HPB Surg. 2009;2009:271986. doi: 10.1155/2009/271986. Epub 2009 Dec 15.
PubMed 20029637Hughes MJ, McNally S, Wigmore SJ. Enhanced recovery following liver surgery: a systematic review and meta-analysis. HPB (Oxford). 2014 Aug;16(8):699-706. doi: 10.1111/hpb.12245. Epub 2014 Mar 24.
PubMed 24661306
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Analgesia Versus Epidural Analgesia in Minor Laparotomic Liver Surgery in an Enhanced Recovery Programme: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02647047
- Acronym / sponsor ID
- VAS-LIVER
- Keywords
- spinal analgesia, epidural analgesia, laparotomic liver resection, ERAS, length of stay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Jan 2016 (estimated)
- 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 purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient's length of hospitalization according to enhanced recovery after surgery (ERAS) principles.
Detailed description
Liver surgery is performed under general anesthesia. Loco-regional analgesia is generally performed before general anesthesia induction to obtain the best post-operative pain control,in association with intravenous analgesic drug administration.
For minor laparotomic surgery (defined as the resection of up to three hepatic segments), if not contraindicated, in our hospital loco-regional analgesia is performed through the placement of a thoracic (T7-T8 or T8-T9) epidural catheter in which a local anesthetic (usually ropivacaine) and an opioid (usually sufentanil) are administered for the first three post-operative days. This is still considered the gold-standard for pain management in this surgery. In our institute, there is a dedicated acute pain service (APS) for pain management in the post-operative period. APS is also responsible for monitoring, registering and treating all side effects related to both the procedure and the drugs used.
In laparoscopic abdominal surgery, instead of epidural analgesia, if not contraindicated, spinal analgesia with low dose morphine before general anesthesia induction is performed. This technique is actually considered efficacy and safe in these type of surgeries.
The investigators therefore decided to test the efficacy of spinal analgesia versus epidural analgesia for minor liver surgery since anterior hepatic segments resection is less painful than major liver surgery because it requires less liver manipulation without significant involvement of the Glisson's capsule. This might imply a less incidence of procedure-related side effects such as post-dural puncture headache or site infections. Moreover, spinal analgesia may allow a earlier post-operative patients mobilization and thus a earlier hospital discharge.
In this randomized controlled trial, the investigators therefore aim to randomize 40 consecutive patients into 2 arms. The experimental group will receive spinal analgesia (morphine 0.2 mg) for post-operative pain control while the control group will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2%: 99 mL + sufentanil 50 mcg/mL: 1 mL).
Randomization will be performed with closed opaque envelopes. During surgery, patients will be monitored as usual. Intraoperative blood losses and fluids administration will be recorded.
Patients randomized into the epidural group will not receive local anesthetic administration through the epidural catheter during the hepatic resection phase to avoid hemodynamic instability. Once the hepatic resection phase is finished and euvolemic status is recovered, epidural analgesia will be administered as mentioned before.
In patients in the spinal group, transversus abdominis plane (TAP) block with ropivacaine 0.375% 20 mL bilaterally or surgical wound infiltration with ropivacaine 0.75% 10- 20 mL will also be performed before anesthesia recovery.
In both groups, post-operative pain control will be managed with intravenous acetaminophen 1000 mg 40 minutes before ending of surgery followed by intravenous administration of acetaminophen 1000 mg every 8 hours and a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy in the post-operative period if not contraindicated.
Patients will be monitored every 24 hours until the achievement of the "ready to discharge" status defined as:
- appropriate oral alimentation;
- optimal pain control with drugs administered orally;
- adequate ability in walking and personal care;
- clinical, laboratory and instrumental absence of any post-operative complication;
- intestinal function recovery;
- patient consent to discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal | Experimental | Procedure: Spinal analgesia, Procedure: Transversus Abdominis Plane block, Procedure: Surgical wound infiltration, Drug: Acetaminophen, Drug: Ketorolac, Drug: RopivacainePatients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection. |
| Epidural | Active comparator | Procedure: Epidural analgesia, Drug: Acetaminophen, Drug: Ketorolac, Drug: Ropivacaine, Drug: SufentanilPatients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years old
- Hospitalized patients
- Surgical indication for minor laparotomic anterior liver resection (II, III, IV and V hepatic segment resection)
- Surgical indication for laparotomic liver metastasectomy
- Ability to provide an informed consent
Key exclusion criteria (9 listed)
- Patient refusal to provide informed consent
- Chronical therapy with opioids
- Pregnancy or breastfeeding
- Alcohol or drug abuse
- Planned or unplanned post-operative intensive care unit admission
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 |
|---|---|---|
| Spinal analgesiaAdministration of morphine 0.2 mg in subarachnoid space. | Procedure or surgery | Spinal |
| Epidural analgesiaBolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL in epidural space | Procedure or surgery | Epidural |
| Transversus Abdominis Plane blockAdministration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally | Procedure or surgery | Spinal |
| Surgical wound infiltrationInfiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL | Procedure or surgery | Spinal |
| AcetaminophenAdministration of 1000 mg of acetaminophen 40 minutes before ending of surgery followed by intravenous administration of 1000 mg every 8 hours | Drug | Epidural, Spinal |
| KetorolacAdministration of a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy | Drug | Epidural, Spinal |
| RopivacaineEpidural bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL | Drug | Epidural |
| SufentanilEpidural continuous epidural infusion of sufentanil 50 mcg/mL 1 mL | Drug | Epidural |
| RopivacaineAdministration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally to obtain the transversus abdominis plane block | Drug | Spinal |
| RopivacaineInfiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL | Drug | Spinal |
Primary outcome
Assessment of postoperative pain control by mean of the visual analog scale early after surgery
Time frame: Within 1 hour after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Assessment of postoperative pain control by mean of the visual analog scale six hours after surgery
Time frame: 6 hours after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Assessment of postoperative pain control by mean of the visual analog scale one day after surgery
Time frame: 24 hours after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Assessment of postoperative pain control by mean of the visual analog scale two days after surgery
Time frame: 48 hours after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Assessment of postoperative pain control by mean of the visual analog scale three days after surgery
Time frame: 72 hours after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Assessment of postoperative pain control by mean of the visual analog scale at hospital discharge
Time frame: Up to 30 days after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
1 secondary outcome
Ready to discharge status
Time frame: Up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Background: PubMed 23662750Tzimas P, Prout J, Papadopoulos G, Mallett SV. Epidural anaesthesia and analgesia for liver resection. Anaesthesia. 2013 Jun;68(6):628-35. doi: 10.1111/anae.12191.
- Background: PubMed 21309939Revie EJ, Massie LJ, McNally SJ, McKeown DW, Garden OJ, Wigmore SJ. Effectiveness of epidural analgesia following open liver resection. HPB (Oxford). 2011 Mar;13(3):206-11. doi: 10.1111/j.1477-2574.2010.00274.x.
- Background: PubMed 24467320Kasivisvanathan R, Abbassi-Ghadi N, Prout J, Clevenger B, Fusai GK, Mallett SV. A prospective cohort study of intrathecal versus epidural analgesia for patients undergoing hepatic resection. HPB (Oxford). 2014 Aug;16(8):768-75. doi: 10.1111/hpb.12222. Epub 2014 Jan 28.
- Background: PubMed 23924906Ntinas A, Kardassis D, Konstantinopoulos I, Kottos P, Manias A, Kyritsi M, Zilianiaki D, Vrochides D. Duration of the thoracic epidural catheter in a fast-track recovery protocol may decrease the length of stay after a major hepatectomy: a case control study. Int J Surg. 2013;11(9):882-5. doi: 10.1016/j.ijsu.2013.07.014. Epub 2013 Aug 4.
- Background: PubMed 20029637Koea JB, Young Y, Gunn K. Fast track liver resection: the effect of a comprehensive care package and analgesia with single dose intrathecal morphine with gabapentin or continuous epidural analgesia. HPB Surg. 2009;2009:271986. doi: 10.1155/2009/271986. Epub 2009 Dec 15.
- Background: PubMed 24661306Hughes MJ, McNally S, Wigmore SJ. Enhanced recovery following liver surgery: a systematic review and meta-analysis. HPB (Oxford). 2014 Aug;16(8):699-706. doi: 10.1111/hpb.12245. Epub 2014 Mar 24.
Related trials for Secondary Malignant Neoplasm of Liver
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
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.
Raffaella Reineke, M.D. contact
Raffaella Reineke, M.D. principal investigator
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal analgesia, Epidural analgesia and Transversus Abdominis Plane block in people with Secondary Malignant Neoplasm of Liver and Liver Diseases, run by Ospedale San Raffaele at 1 site in Italy.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Jan 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Bignami, M.D. (+39.02.2643.4524, bignami.elena@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postoperative pain control by mean of the visual analog scale early after surgery (time frame: Within 1 hour after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647047, which also lists 6 linked publications.
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 6 Jan 2016.