Trial Outcomes & Findings for Continuous Subpleural Infusion of Bupivacaine (NCT NCT01566838)
NCT ID: NCT01566838
Last Updated: 2017-12-20
Results Overview
The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Postoperative day 1 through postoperative day 30
Results posted on
2017-12-20
Participant Flow
Participant milestones
| Measure |
On-q Pump
Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Three patients did not have follow-up data for the study and were therefore excluded from analysis
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
|
Standard of Care
Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
38
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Subpleural Infusion of Bupivacaine
Baseline characteristics by cohort
| Measure |
On-q Pump
n=41 Participants
Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
|
Standard of Care
n=42 Participants
Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 12.4 • n=113 Participants
|
62.9 years
STANDARD_DEVIATION 12.1 • n=163 Participants
|
62.95 years
STANDARD_DEVIATION 12.25 • n=160 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=113 Participants
|
21 Participants
n=163 Participants
|
42 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=113 Participants
|
21 Participants
n=163 Participants
|
41 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
34 participants
n=113 Participants
|
35 participants
n=163 Participants
|
69 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=113 Participants
|
7 participants
n=163 Participants
|
14 participants
n=160 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=113 Participants
|
42 participants
n=163 Participants
|
83 participants
n=160 Participants
|
|
Surgical Procedure Performed
Lobectomy
|
23 participants
n=113 Participants
|
20 participants
n=163 Participants
|
43 participants
n=160 Participants
|
|
Surgical Procedure Performed
Wedge
|
18 participants
n=113 Participants
|
16 participants
n=163 Participants
|
34 participants
n=160 Participants
|
|
Surgical Procedure Performed
Other
|
0 participants
n=113 Participants
|
6 participants
n=163 Participants
|
6 participants
n=160 Participants
|
|
Diagnosis
Cancer
|
30 participants
n=113 Participants
|
27 participants
n=163 Participants
|
57 participants
n=160 Participants
|
|
Diagnosis
Interstitial Lung Disease
|
7 participants
n=113 Participants
|
12 participants
n=163 Participants
|
19 participants
n=160 Participants
|
|
Diagnosis
Other
|
4 participants
n=113 Participants
|
3 participants
n=163 Participants
|
7 participants
n=160 Participants
|
|
Side
Left
|
11 participants
n=113 Participants
|
12 participants
n=163 Participants
|
23 participants
n=160 Participants
|
|
Side
Right
|
30 participants
n=113 Participants
|
29 participants
n=163 Participants
|
59 participants
n=160 Participants
|
|
Side
Unspecified
|
0 participants
n=113 Participants
|
1 participants
n=163 Participants
|
1 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 1 through postoperative day 30Population: 30-day pain medication usage
The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.
Outcome measures
| Measure |
On-q Pump
n=38 Participants
Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
|
Standard of Care
n=42 Participants
Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management
|
|---|---|---|
|
Number of Participants With and Without 30-Day Pain Medication Usage
Yes
|
8 participants
|
6 participants
|
|
Number of Participants With and Without 30-Day Pain Medication Usage
No
|
30 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Postoperative day 1 through day 7Population: 7-day paresthesia
Participants experiencing parasthesia (a tingling or pricking sensation usually caused by pressure or damage to nerves) through postoperative day 7
Outcome measures
| Measure |
On-q Pump
n=38 Participants
Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
|
Standard of Care
n=42 Participants
Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management
|
|---|---|---|
|
7-day Paresthesia
Yes
|
3 participants
|
1 participants
|
|
7-day Paresthesia
No
|
25 participants
|
25 participants
|
|
7-day Paresthesia
Unknown
|
10 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 daysPopulation: In-hospital length of stay (days)
Hospital length of stay for this operation will be recorded and analyzed for each arm of the study.
Outcome measures
| Measure |
On-q Pump
n=38 Participants
Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
|
Standard of Care
n=42 Participants
Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management
|
|---|---|---|
|
Length of Stay
|
1 days
Interval 0.0 to 1.0
|
1 days
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 30-day incidence of paresthesia
30-day incidence of paresthesia (tingling or pricking sensation, usually caused by pressure or nerve damage)
Outcome measures
| Measure |
On-q Pump
n=38 Participants
Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
|
Standard of Care
n=42 Participants
Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management
|
|---|---|---|
|
30-day Incidence of Parasthesia
Yes
|
13 participants
|
15 participants
|
|
30-day Incidence of Parasthesia
No
|
25 participants
|
27 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 30 day return to work
Returned to work in 30 days?
Outcome measures
| Measure |
On-q Pump
n=38 Participants
Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
|
Standard of Care
n=42 Participants
Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management
|
|---|---|---|
|
Return to Work
Yes
|
18 participants
|
20 participants
|
|
Return to Work
No
|
3 participants
|
3 participants
|
|
Return to Work
Not currently working
|
17 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Resuming of physical activity
Did the patient resume physical activity.
Outcome measures
| Measure |
On-q Pump
n=38 Participants
Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
|
Standard of Care
n=42 Participants
Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
Standard acute pain management
|
|---|---|---|
|
Resumed Physical Activity
Yes
|
37 participants
|
37 participants
|
|
Resumed Physical Activity
No
|
1 participants
|
5 participants
|
Adverse Events
On-q Pump
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sandeep Khandhar, MD
Cardiac, Vascular, and Thoracic Surgery Associates
Phone: 703-280-5858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place