Trial Outcomes & Findings for TEA vs. PVB vs. PCA in Liver Resection Surgery (NCT NCT02192879)
NCT ID: NCT02192879
Last Updated: 2016-10-24
Results Overview
Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days
Results posted on
2016-10-24
Participant Flow
Participant milestones
| Measure |
Thoracic Epidural
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TEA vs. PVB vs. PCA in Liver Resection Surgery
Baseline characteristics by cohort
| Measure |
Thoracic Epidural
n=3 Participants
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
n=4 Participants
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
n=3 Participants
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 daysPost-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).
Outcome measures
| Measure |
Thoracic Epidural
n=3 Participants
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
n=4 Participants
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
n=3 Participants
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
|---|---|---|---|
|
Highest VAS Pain Score at Rest
|
5.67 units on a scale
Standard Deviation 2.08
|
7.0 units on a scale
Standard Deviation 2.94
|
7.67 units on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications ariseHospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.
Outcome measures
| Measure |
Thoracic Epidural
n=3 Participants
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
n=4 Participants
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
n=3 Participants
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
|---|---|---|---|
|
Hospital Length of Stay
|
10.33 days
Standard Deviation 4.93
|
6.25 days
Standard Deviation 2.5
|
7.0 days
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: postoperatively until return of bowel function, up to 7 daysPostoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.
Outcome measures
| Measure |
Thoracic Epidural
n=3 Participants
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
n=4 Participants
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
n=3 Participants
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
|---|---|---|---|
|
Gastrointestinal Recovery
|
4.33 days
Standard Deviation 0.58
|
4.25 days
Standard Deviation 2.63
|
5.33 days
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 daysCumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.
Outcome measures
| Measure |
Thoracic Epidural
n=3 Participants
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
n=4 Participants
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
n=3 Participants
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
|---|---|---|---|
|
Cumulative Postoperative Opioid Requirement
|
388.33 mg
Standard Deviation 430.71
|
224.6 mg
Standard Deviation 236.5
|
176.20 mg
Standard Deviation 40.14
|
SECONDARY outcome
Timeframe: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications ariseMajor surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.
Outcome measures
| Measure |
Thoracic Epidural
n=3 Participants
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
n=4 Participants
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
n=3 Participants
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
|---|---|---|---|
|
Incidence of Major Postoperative Complication
|
2 complications
|
2 complications
|
0 complications
|
SECONDARY outcome
Timeframe: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 daysPost-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).
Outcome measures
| Measure |
Thoracic Epidural
n=3 Participants
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
n=4 Participants
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
n=3 Participants
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
|---|---|---|---|
|
Highest VAS Pain Scores With Coughing
|
7.33 units on a scale
Standard Deviation 2.52
|
8.0 units on a scale
Standard Deviation 2.45
|
8.33 units on a scale
Standard Deviation 1.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 daysPopulation: only patients who had a catheter
Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored
Outcome measures
| Measure |
Thoracic Epidural
n=3 Participants
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
n=4 Participants
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
|---|---|---|---|
|
Serious Adverse Events Associated With Regional Catheter Placement
|
0 serious adverse events
|
0 serious adverse events
|
—
|
Adverse Events
Thoracic Epidural
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Paravertebral Catheter
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient-Controlled Analgesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thoracic Epidural
n=3 participants at risk
thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|
Continuous Paravertebral Catheter
n=4 participants at risk
continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|
Patient-Controlled Analgesia
n=3 participants at risk
Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/3
|
25.0%
1/4
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
diaphragm leak
|
33.3%
1/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
bile leak
|
33.3%
1/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Eye disorders
blurred vision
|
0.00%
0/3
|
25.0%
1/4
|
0.00%
0/3
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place