Pain Control After Elective HepatectomyPhase 4NCT02909322
Epidural Versus Paravertebral Block Analgesia After Hepatectomy
A Phase 4 study testing Bupivacaine and Hydromorphone and Ropivacaine and Hydromorphone in people with Pain Control After Elective Hepatectomy, run by Dr. Anthony Ho at 1 site in Canada.
Trial summary
The best mode of analgesia delivery after hepatectomy is currently unknown. Many institutions routinely use continuous epidural analgesia (CEA) for pain control in this patient population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain Control After Elective Hepatectomy
- What is being tested?
- Bupivacaine and Hydromorphone and Ropivacaine and Hydromorphone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Mar 2023
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age
- ASA I-III
- Undergoing elective liver resection through right subcostal incision
- Proficient in English
- Competent to give consent
Who cannot join
- Not given informed consent
- Not competent to give informed consent
- Dementia or neurological impairment
- Jaundice (bilirubin > 50μmol/L)
- Liver resection combined with secondary surgical procedure
- Contraindication to either epidural or paravertebral block (INR ≥ 1.6, platelet count < 100,000/mm3, fever, previous back surgery)
Show all 12Show fewer
- Anticipated significant coagulopathy post-liver resection (as indicated by a Model for End-Stage Liver Disease score >8 or predicted liver resection of more than 500g)
- Contraindications to any of the study medications
- Remain intubated in the postoperative period, due to inability to assess pain scores
- Midline incision and/or any type of extended incision that is not restricted to the standard right subcostal incision
- Body mass index < 18 or > 40
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Kingston General Hospital
Kingston, Ontario, K7L2V7
Debbie DuMerton Shore, RN, 613-548-7827, shored@kgh.kari.net
Anthony Ho, MD
About this study
Official title: Analgesic and Hemodynamic Effects of Continuous Epidural Analgesia Compared to Paravertebral Block in Liver Resection Patients
The best mode of analgesia delivery after hepatectomy is currently unknown. Many institutions routinely use continuous epidural analgesia (CEA) for pain control in this patient population. A functioning CEA provides adequate analgesia, but is associated with high failure rates (20-30%) and sometimes significant hemodynamic disturbances (hypotension) requiring an increased amount of intravenous fluid and blood products to maintain homeostasis. Furthermore, its safety has been the subject of debate in liver resection patients due to the elevated risk of epidural hematoma and its serious neurological consequences. These limitations highlight the need to explore other options for analgesic control after hepatectomy, such as paravertebral block (PVB). PVB has been shown to provide similar analgesia with a lower incidence of pulmonary complications, side effects (pruritis, urinary retention, nausea and vomiting, hypotension), and failure rates (6.1%) when compared to CEA in thoracic surgery, and therefore has been suggested as a safer alternative in hepatectomy patients. Despite this, there are no studies comparing the efficacy of CEA and PVB as analgesic techniques after hepatectomy. The investigators propose a randomized controlled trial to compare the analgesic efficacy, side effects, and complications associated with CEA and PVB in patients undergoing elective hepatectomy through a right subcostal incision.
Read the detailed description
The best mode of analgesia delivery after hepatectomy is currently unknown. Many institutions routinely use continuous epidural analgesia (CEA) for pain control in hepatectomy patients. However, its safety has been the subject of debate. Paravertebral block (PVB) has been suggested as a safer alternative in this patient population. Despite this, there are no studies comparing the efficacy of CEA and PVB as analgesic techniques after hepatectomy. Although CEA provides high quality analgesia, and reduces cardiovascular and respiratory complications and the incidence of postoperative thromboembolic events, it is associated with hypotension and complications such as epidural hematoma, epidural abscess, and spinal cord injury, which are serious concerns in hepatectomy patients. Furthermore, patients given CEA are more likely to need blood transfusions, and transfused patients have significantly higher mortality rates, complications related to infection, and hospital length of stay. PVB is a less popular technique that involves injecting local anesthetic (LA) into the paravertebral space. This technique has been successfully used for pain relief after several surgical procedures, including ablation of hepatic tumours and hepatectomy. Although CEA and PVB have never been compared in hepatectomy patients, they have been compared in thoracotomy patients; in this patient population, PVB and CEA provide similar levels of pain control, but CEA is associated with more complications and side effects such as hypotension, nausea, vomiting, and urinary retention, and PVB is associated with better pulmonary function. Both CEA and PVB are reasonably effective for post-hepatectomy analgesia compared to placebo, and have their own strengths and weaknesses. The gold standard CEA provides excellent analgesia at the expense of more intense hypotension, significant failure rates (20-30%), and a higher risk of epidural hematoma and its serious neurological consequences. These limitations highlight the need to explore other options for analgesic control after hepatectomy such as PVB. Therefore, the investigators propose a randomized controlled trial to compare the analgesic efficacy, hemodynamic changes, and side effects in CEA and PVB in patients undergoing elective hepatectomy through a right subcostal incision. Since CEA is currently the gold standard for analgesia after hepatectomy, the investigators propose a non-inferiority trial to determine whether PVB produces a similar analgesic profile to CEA in hepatectomy patients, while being associated with fewer adverse side effects.
This is a randomized, controlled, pilot study. It will consist of two groups of participants undergoing hepatectomy: those receiving CEA, and those receiving PVB for analgesic control. CEA and PVB protocols will follow the usual standard of care at Kingston General Hospital (KGH). Participants in the CEA group will receive bupivacaine with hydromorphone infusion after induction of general anesthesia for surgery. Participants in the PVB group will receive a bolus dose of ropivacaine, and then ropivacaine infusion after induction of general anesthesia. Upon emergence from anesthesia, all participants will be transferred to the post-anesthetic care unit (PACU). Here, CEA participants will be started on patient-controlled epidural analgesia (PCEA) of bupivacaine and hydromorphone plus a self-administered bolus dose with a lockout period of 30 min if participants require additional pain relief, and PVB participants will be started on a patient-controlled paravertebral analgesia (PCPA) of ropivacaine plus a self-administered bolus dose with a lockout period of 30 min if participants require additional pain relief. All participants will receive oral hydromorphone every 4 hours as required for breakthrough pain relief starting on the morning of the second postoperative day. A member of the research team will assess the presence and severity of pain and nausea during the postoperative period. The assessments will be performed at 30 minutes after arrival to the PACU, and thereafter at 4, 8, 24, 48, and 72 hours after surgery. Investigators will ask all participants to score their pain at rest and with coughing on a numeric rating scale (NRS, where 0=no pain and 10=worst pain imaginable), and nausea scores (0=none, 1=mild, 2=moderate, 3=vomiting) at each of the above listed time points. At 72 hours after surgery, participant satisfaction with regard to analgesia will be assessed (1=very poor, 2=poor, 3=satisfactory, 4=good, 5=excellent). The requirement for breakthrough pain relief, the time of first breakthrough pain relief request, and cumulative opioid consumption will be recorded during the postoperative 72 hours.
- Conditions
- Pain Control After Elective Hepatectomy
- Being tested
- Bupivacaine and Hydromorphone, Ropivacaine and Hydromorphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine and HydromorphoneProcedure or surgery
Patients receive bupivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery.
Ropivacaine and HydromorphoneProcedure or surgery
Patients receive ropivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Epidural Analgesia | Active comparator | Analgesic medications will be given via epidural, the standard of care. Receives: Procedure: Bupivacaine and Hydromorphone |
| Paravertebral Block Analgesia | Experimental | Analgesic medications will be given via the paravertebral space. Receives: Procedure: Ropivacaine and Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Cumulative opioid consumption during the postoperative period will be recorded.
Measured: 0-72 hours after surgery
Time to first request for opioids
The first time after surgery each participant asks for opioid medication for pain will be recorded.
Measured: 0-72 hours after surgery
Pain scores
At the specified time points, participants will rate their pain on a scale from 0 to 10.
Measured: 30min, 4, 8, 24, 48, and 72 hours after surgery
Secondary outcomes (14)
Nausea
At the specified time points, participants will rate their nausea.
Measured: 30min, 4, 8, 24, 48, and 72 hours after surgery
Satisfaction with analgesia
Participants will rate their satisfaction with their analgesia.
Measured: 72 hours after surgery
Success rates of CEA and PVB
The number of successful CEA and PVB procedures will be recorded.
Measured: 0-72 hours after surgery
Failure rates of CEA and PVB
The number of therapeutic failures of CEA and PVB procedures will be recorded.
Measured: 0-72 hours after surgery
Mean arterial pressure
Mean arterial pressure will be recorded.
Measured: 0-72 hours after surgery
Central venous pressure
Central venous pressure will be recorded.
Measured: 0-72 hours after surgery
Urine output
Urine output will be recorded.
Measured: 0-72 hours after surgery
Acid-base
pH, bicarbonate, partial pressure of carbon dioxide, and partial pressure of oxygen in the blood will be recorded.
Measured: 0-72 hours after surgery
Intravenous fluid volume
Total volume of crystalloids, colloids, and blood products given perioperatively and during the 72 hours after surgery will be recorded.
Measured: 0-72 hours after surgery
Vasopressor volume
Total volume of vasopressors given perioperatively and during the 72 hours after surgery will be recorded.
Measured: 0-72 hours after surgery
Resumption of full oral diet
The number of days taken to resume a full oral diet will be recorded.
Measured: 0-72 hours after surgery
Hospital length of stay
The number of days until participants are discharged will be recorded.
Measured: 0-72 hours after surgery
Adverse events
Any postoperative adverse events will be recorded.
Measured: 0-72 hours after surgery
Demographic data
Descriptive demographic data will be recorded.
Measured: Upon enrollment up to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Pain Control After Elective HepatectomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Anthony Ho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Anthony Ho, Queen's University
- Investigators
- Anthony MH Ho, MD,FRCPC, Principal investigator, Queen's University/ Kingston Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909322
- Sponsor's protocol ID
- ANAE-270-15
- Status last verified
- Dec 2022
- First submitted
- 13 Jul 2016
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Page A, Rostad B, Staley CA, Levy JH, Park J, Goodman M, Sarmiento JM, Galloway J, Delman KA, Kooby DA. Epidural analgesia in hepatic resection. J Am Coll Surg. 2008 Jun;206(6):1184-92. doi: 10.1016/j.jamcollsurg.2007.12.041. Epub 2008 Apr 14.
PubMed 18501817Siniscalchi A, Begliomini B, De Pietri L, Braglia V, Gazzi M, Masetti M, Di Benedetto F, Pinna AD, Miller CM, Pasetto A. Increased prothrombin time and platelet counts in living donor right hepatectomy: implications for epidural anesthesia. Liver Transpl. 2004 Sep;10(9):1144-9. doi: 10.1002/lt.20235.
PubMed 15350005Choi SJ, Gwak MS, Ko JS, Kim GS, Ahn HJ, Yang M, Hahm TS, Lee SM, Kim MH, Joh JW. The changes in coagulation profile and epidural catheter safety for living liver donors: a report on 6 years of our experience. Liver Transpl. 2007 Jan;13(1):62-70. doi: 10.1002/lt.20933.
PubMed 17192873Matot I, Scheinin O, Eid A, Jurim O. Epidural anesthesia and analgesia in liver resection. Anesth Analg. 2002 Nov;95(5):1179-81, table of contents. doi: 10.1097/00000539-200211000-00009.
PubMed 12401587Shontz R, Karuparthy V, Temple R, Brennan TJ. Prevalence and risk factors predisposing to coagulopathy in patients receiving epidural analgesia for hepatic surgery. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):308-11. doi: 10.1097/AAP.0b013e3181ac7d00.
PubMed 19574863Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
PubMed 11460814Stamenkovic DM, Jankovic ZB, Toogood GJ, Lodge JP, Bellamy MC. Epidural analgesia and liver resection: postoperative coagulation disorders and epidural catheter removal. Minerva Anestesiol. 2011 Jul;77(7):671-9. Epub 2008 Nov 27.
PubMed 19037193Cook TM, Counsell D, Wildsmith JA; Royal College of Anaesthetists Third National Audit Project. Major complications of central neuraxial block: report on the Third National Audit Project of the Royal College of Anaesthetists. Br J Anaesth. 2009 Feb;102(2):179-90. doi: 10.1093/bja/aen360. Epub 2009 Jan 12.
PubMed 19139027Weinberg L, Scurrah N, Gunning K, McNicol L. Postoperative changes in prothrombin time following hepatic resection: implications for perioperative analgesia. Anaesth Intensive Care. 2006 Aug;34(4):438-43. doi: 10.1177/0310057X0603400405.
PubMed 16913338Wong-Lun-Hing EM, van Dam RM, Welsh FK, Wells JK, John TG, Cresswell AB, Dejong CH, Rees M. Postoperative pain control using continuous i.m. bupivacaine infusion plus patient-controlled analgesia compared with epidural analgesia after major hepatectomy. HPB (Oxford). 2014 Jul;16(7):601-9. doi: 10.1111/hpb.12183. Epub 2013 Oct 23.
PubMed 24151899Revie 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 21309939McLeod G, Davies H, Munnoch N, Bannister J, MacRae W. Postoperative pain relief using thoracic epidural analgesia: outstanding success and disappointing failures. Anaesthesia. 2001 Jan;56(1):75-81. doi: 10.1046/j.1365-2044.2001.01763-7.x.
PubMed 11167441Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.
PubMed 12402719Tzimas 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 23662750Koea 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 20029637
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic and Hemodynamic Effects of Continuous Epidural Analgesia Compared to Paravertebral Block in Liver Resection Patients
- ClinicalTrials.gov ID
- NCT02909322
- Acronym / sponsor ID
- ANAE-270-15
- Conditions
- Pain Control After Elective Hepatectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dr. Anthony HoUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 21 Sep 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 best mode of analgesia delivery after hepatectomy is currently unknown. Many institutions routinely use continuous epidural analgesia (CEA) for pain control in this patient population. A functioning CEA provides adequate analgesia, but is associated with high failure rates (20-30%) and sometimes significant hemodynamic disturbances (hypotension) requiring an increased amount of intravenous fluid and blood products to maintain homeostasis. Furthermore, its safety has been the subject of debate in liver resection patients due to the elevated risk of epidural hematoma and its serious neurological consequences. These limitations highlight the need to explore other options for analgesic control after hepatectomy, such as paravertebral block (PVB). PVB has been shown to provide similar analgesia with a lower incidence of pulmonary complications, side effects (pruritis, urinary retention, nausea and vomiting, hypotension), and failure rates (6.1%) when compared to CEA in thoracic surgery, and therefore has been suggested as a safer alternative in hepatectomy patients. Despite this, there are no studies comparing the efficacy of CEA and PVB as analgesic techniques after hepatectomy. The investigators propose a randomized controlled trial to compare the analgesic efficacy, side effects, and complications associated with CEA and PVB in patients undergoing elective hepatectomy through a right subcostal incision.
Detailed description
The best mode of analgesia delivery after hepatectomy is currently unknown. Many institutions routinely use continuous epidural analgesia (CEA) for pain control in hepatectomy patients. However, its safety has been the subject of debate. Paravertebral block (PVB) has been suggested as a safer alternative in this patient population. Despite this, there are no studies comparing the efficacy of CEA and PVB as analgesic techniques after hepatectomy. Although CEA provides high quality analgesia, and reduces cardiovascular and respiratory complications and the incidence of postoperative thromboembolic events, it is associated with hypotension and complications such as epidural hematoma, epidural abscess, and spinal cord injury, which are serious concerns in hepatectomy patients. Furthermore, patients given CEA are more likely to need blood transfusions, and transfused patients have significantly higher mortality rates, complications related to infection, and hospital length of stay. PVB is a less popular technique that involves injecting local anesthetic (LA) into the paravertebral space. This technique has been successfully used for pain relief after several surgical procedures, including ablation of hepatic tumours and hepatectomy. Although CEA and PVB have never been compared in hepatectomy patients, they have been compared in thoracotomy patients; in this patient population, PVB and CEA provide similar levels of pain control, but CEA is associated with more complications and side effects such as hypotension, nausea, vomiting, and urinary retention, and PVB is associated with better pulmonary function. Both CEA and PVB are reasonably effective for post-hepatectomy analgesia compared to placebo, and have their own strengths and weaknesses. The gold standard CEA provides excellent analgesia at the expense of more intense hypotension, significant failure rates (20-30%), and a higher risk of epidural hematoma and its serious neurological consequences. These limitations highlight the need to explore other options for analgesic control after hepatectomy such as PVB. Therefore, the investigators propose a randomized controlled trial to compare the analgesic efficacy, hemodynamic changes, and side effects in CEA and PVB in patients undergoing elective hepatectomy through a right subcostal incision. Since CEA is currently the gold standard for analgesia after hepatectomy, the investigators propose a non-inferiority trial to determine whether PVB produces a similar analgesic profile to CEA in hepatectomy patients, while being associated with fewer adverse side effects.
This is a randomized, controlled, pilot study. It will consist of two groups of participants undergoing hepatectomy: those receiving CEA, and those receiving PVB for analgesic control. CEA and PVB protocols will follow the usual standard of care at Kingston General Hospital (KGH). Participants in the CEA group will receive bupivacaine with hydromorphone infusion after induction of general anesthesia for surgery. Participants in the PVB group will receive a bolus dose of ropivacaine, and then ropivacaine infusion after induction of general anesthesia. Upon emergence from anesthesia, all participants will be transferred to the post-anesthetic care unit (PACU). Here, CEA participants will be started on patient-controlled epidural analgesia (PCEA) of bupivacaine and hydromorphone plus a self-administered bolus dose with a lockout period of 30 min if participants require additional pain relief, and PVB participants will be started on a patient-controlled paravertebral analgesia (PCPA) of ropivacaine plus a self-administered bolus dose with a lockout period of 30 min if participants require additional pain relief. All participants will receive oral hydromorphone every 4 hours as required for breakthrough pain relief starting on the morning of the second postoperative day. A member of the research team will assess the presence and severity of pain and nausea during the postoperative period. The assessments will be performed at 30 minutes after arrival to the PACU, and thereafter at 4, 8, 24, 48, and 72 hours after surgery. Investigators will ask all participants to score their pain at rest and with coughing on a numeric rating scale (NRS, where 0=no pain and 10=worst pain imaginable), and nausea scores (0=none, 1=mild, 2=moderate, 3=vomiting) at each of the above listed time points. At 72 hours after surgery, participant satisfaction with regard to analgesia will be assessed (1=very poor, 2=poor, 3=satisfactory, 4=good, 5=excellent). The requirement for breakthrough pain relief, the time of first breakthrough pain relief request, and cumulative opioid consumption will be recorded during the postoperative 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Epidural Analgesia | Active comparator | Procedure: Bupivacaine and HydromorphoneAnalgesic medications will be given via epidural, the standard of care. |
| Paravertebral Block Analgesia | Experimental | Procedure: Ropivacaine and HydromorphoneAnalgesic medications will be given via the paravertebral space. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years of age
- ASA I-III
- Undergoing elective liver resection through right subcostal incision
- Proficient in English
- Competent to give consent
Key exclusion criteria (12 listed)
- Not given informed consent
- Not competent to give informed consent
- Dementia or neurological impairment
- Jaundice (bilirubin > 50μmol/L)
- Liver resection combined with secondary surgical procedure
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 |
|---|---|---|
| Bupivacaine and HydromorphonePatients receive bupivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery. | Procedure or surgery | Continuous Epidural Analgesia |
| Ropivacaine and HydromorphonePatients receive ropivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery. | Procedure or surgery | Paravertebral Block Analgesia |
Primary outcome
Opioid consumption
Time frame: 0-72 hours after surgery
Cumulative opioid consumption during the postoperative period will be recorded.
Time to first request for opioids
Time frame: 0-72 hours after surgery
The first time after surgery each participant asks for opioid medication for pain will be recorded.
Pain scores
Time frame: 30min, 4, 8, 24, 48, and 72 hours after surgery
At the specified time points, participants will rate their pain on a scale from 0 to 10.
14 secondary outcomes
Nausea
Time frame: 30min, 4, 8, 24, 48, and 72 hours after surgery
Satisfaction with analgesia
Time frame: 72 hours after surgery
Success rates of CEA and PVB
Time frame: 0-72 hours after surgery
Failure rates of CEA and PVB
Time frame: 0-72 hours after surgery
Mean arterial pressure
Time frame: 0-72 hours after surgery
Central venous pressure
Time frame: 0-72 hours after surgery
Urine output
Time frame: 0-72 hours after surgery
Acid-base
Time frame: 0-72 hours after surgery
Intravenous fluid volume
Time frame: 0-72 hours after surgery
Vasopressor volume
Time frame: 0-72 hours after surgery
Resumption of full oral diet
Time frame: 0-72 hours after surgery
Hospital length of stay
Time frame: 0-72 hours after surgery
Adverse events
Time frame: 0-72 hours after surgery
Demographic data
Time frame: Upon enrollment up to 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Background: PubMed 18501817Page A, Rostad B, Staley CA, Levy JH, Park J, Goodman M, Sarmiento JM, Galloway J, Delman KA, Kooby DA. Epidural analgesia in hepatic resection. J Am Coll Surg. 2008 Jun;206(6):1184-92. doi: 10.1016/j.jamcollsurg.2007.12.041. Epub 2008 Apr 14.
- Background: PubMed 15350005Siniscalchi A, Begliomini B, De Pietri L, Braglia V, Gazzi M, Masetti M, Di Benedetto F, Pinna AD, Miller CM, Pasetto A. Increased prothrombin time and platelet counts in living donor right hepatectomy: implications for epidural anesthesia. Liver Transpl. 2004 Sep;10(9):1144-9. doi: 10.1002/lt.20235.
- Background: PubMed 17192873Choi SJ, Gwak MS, Ko JS, Kim GS, Ahn HJ, Yang M, Hahm TS, Lee SM, Kim MH, Joh JW. The changes in coagulation profile and epidural catheter safety for living liver donors: a report on 6 years of our experience. Liver Transpl. 2007 Jan;13(1):62-70. doi: 10.1002/lt.20933.
- Background: PubMed 12401587Matot I, Scheinin O, Eid A, Jurim O. Epidural anesthesia and analgesia in liver resection. Anesth Analg. 2002 Nov;95(5):1179-81, table of contents. doi: 10.1097/00000539-200211000-00009.
- Background: PubMed 19574863Shontz R, Karuparthy V, Temple R, Brennan TJ. Prevalence and risk factors predisposing to coagulopathy in patients receiving epidural analgesia for hepatic surgery. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):308-11. doi: 10.1097/AAP.0b013e3181ac7d00.
- Background: PubMed 11460814Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
- Background: PubMed 19037193Stamenkovic DM, Jankovic ZB, Toogood GJ, Lodge JP, Bellamy MC. Epidural analgesia and liver resection: postoperative coagulation disorders and epidural catheter removal. Minerva Anestesiol. 2011 Jul;77(7):671-9. Epub 2008 Nov 27.
- Background: PubMed 19139027Cook TM, Counsell D, Wildsmith JA; Royal College of Anaesthetists Third National Audit Project. Major complications of central neuraxial block: report on the Third National Audit Project of the Royal College of Anaesthetists. Br J Anaesth. 2009 Feb;102(2):179-90. doi: 10.1093/bja/aen360. Epub 2009 Jan 12.
- Background: PubMed 16913338Weinberg L, Scurrah N, Gunning K, McNicol L. Postoperative changes in prothrombin time following hepatic resection: implications for perioperative analgesia. Anaesth Intensive Care. 2006 Aug;34(4):438-43. doi: 10.1177/0310057X0603400405.
- Background: PubMed 24151899Wong-Lun-Hing EM, van Dam RM, Welsh FK, Wells JK, John TG, Cresswell AB, Dejong CH, Rees M. Postoperative pain control using continuous i.m. bupivacaine infusion plus patient-controlled analgesia compared with epidural analgesia after major hepatectomy. HPB (Oxford). 2014 Jul;16(7):601-9. doi: 10.1111/hpb.12183. Epub 2013 Oct 23.
- 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 11167441McLeod G, Davies H, Munnoch N, Bannister J, MacRae W. Postoperative pain relief using thoracic epidural analgesia: outstanding success and disappointing failures. Anaesthesia. 2001 Jan;56(1):75-81. doi: 10.1046/j.1365-2044.2001.01763-7.x.
- Individual participant dataSharing planned: No
Related trials for Pain Control After Elective Hepatectomy
Active, not recruitingPhase 3
Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Liver Resection
Liver Cancer, Pain Management
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.
Anthony MH Ho, MD,FRCPC principal investigator
Queen's University/ Kingston Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Hydromorphone and Ropivacaine and Hydromorphone in people with Pain Control After Elective Hepatectomy, run by Dr. Anthony Ho at 1 site in Canada.
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 12 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 5 Dec 2022. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anthony MH Ho, MD, FRCPC (613-548-7827, anthony.ho@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 0-72 hours after surgery). The study lists 3 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 NCT02909322, which also lists 50 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 5 Dec 2022.