Trial Outcomes & Findings for PAIN - Postoperative Analgesia INvestigation (NCT NCT02111746)
NCT ID: NCT02111746
Last Updated: 2018-10-16
Results Overview
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
350 participants
Primary outcome timeframe
postoperative day 1
Results posted on
2018-10-16
Participant Flow
Participant milestones
| Measure |
Exparel®
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
171
|
|
Overall Study
COMPLETED
|
169
|
169
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age wasn't collected for all participants.
Baseline characteristics by cohort
| Measure |
Exparel®
n=172 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=171 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 14.8 • n=172 Participants • Age wasn't collected for all participants.
|
61 years
STANDARD_DEVIATION 13.9 • n=171 Participants • Age wasn't collected for all participants.
|
60.7 years
STANDARD_DEVIATION 14.2 • n=343 Participants • Age wasn't collected for all participants.
|
|
Sex: Female, Male
Female
|
55 Participants
n=172 Participants
|
67 Participants
n=171 Participants
|
122 Participants
n=343 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=172 Participants
|
104 Participants
n=171 Participants
|
221 Participants
n=343 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=172 Participants • Ethnicity data wasn't collected from all participants.
|
26 Participants
n=171 Participants • Ethnicity data wasn't collected from all participants.
|
53 Participants
n=343 Participants • Ethnicity data wasn't collected from all participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=172 Participants • Ethnicity data wasn't collected from all participants.
|
132 Participants
n=171 Participants • Ethnicity data wasn't collected from all participants.
|
271 Participants
n=343 Participants • Ethnicity data wasn't collected from all participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=172 Participants • Ethnicity data wasn't collected from all participants.
|
13 Participants
n=171 Participants • Ethnicity data wasn't collected from all participants.
|
19 Participants
n=343 Participants • Ethnicity data wasn't collected from all participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
0 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
0 Participants
n=290 Participants • Race data wasn't collected from all participants.
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
4 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
10 Participants
n=290 Participants • Race data wasn't collected from all participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
0 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
0 Participants
n=290 Participants • Race data wasn't collected from all participants.
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
25 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
60 Participants
n=290 Participants • Race data wasn't collected from all participants.
|
|
Race (NIH/OMB)
White
|
98 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
103 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
201 Participants
n=290 Participants • Race data wasn't collected from all participants.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
0 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
0 Participants
n=290 Participants • Race data wasn't collected from all participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
13 Participants
n=145 Participants • Race data wasn't collected from all participants.
|
19 Participants
n=290 Participants • Race data wasn't collected from all participants.
|
|
Region of Enrollment
United States
|
172 participants
n=172 Participants
|
171 participants
n=171 Participants
|
343 participants
n=343 Participants
|
PRIMARY outcome
Timeframe: postoperative day 1Population: Intention-to-treat analysis. Data for this measure was collected for only 153 in the Exparel arm and 152 in the Regular Bupivacaine group.
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Outcome measures
| Measure |
Exparel®
n=153 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=152 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
|---|---|---|
|
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
|
5.05 units on a scale
Standard Deviation 2.8
|
5.02 units on a scale
Standard Deviation 2.68
|
PRIMARY outcome
Timeframe: postoperative day 2Population: Intention-to-treat analysis. Data for this measure was collected for only 160 in the Exparel arm and 159 in the Regular Bupivacaine group.
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Outcome measures
| Measure |
Exparel®
n=160 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=159 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
|---|---|---|
|
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
|
4.69 units on a scale
Standard Deviation 2.49
|
4.08 units on a scale
Standard Deviation 2.64
|
PRIMARY outcome
Timeframe: postoperative day 3Population: Intention-to-treat analysis. Data for this measure was collected for only 159 in the Exparel arm and 151 in the Regular Bupivacaine group.
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Outcome measures
| Measure |
Exparel®
n=159 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=151 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
|---|---|---|
|
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
|
3.71 units on a scale
Standard Deviation 2.42
|
3.03 units on a scale
Standard Deviation 2.47
|
PRIMARY outcome
Timeframe: postoperative day 1Population: Intention-to-treat analysis. Data for this measure was collected for only 144 in the Exparel arm and 146 in the Regular Bupivacaine group.
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Outcome measures
| Measure |
Exparel®
n=144 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=146 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
|---|---|---|
|
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
|
4.08 units on a scale
Standard Deviation 1.16
|
3.99 units on a scale
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: postoperative day 2Population: Intention-to-treat analysis. Data for this measure was collected for only 155 in the Exparel arm and 155 in the Regular Bupivacaine group.
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Outcome measures
| Measure |
Exparel®
n=155 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=155 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
|---|---|---|
|
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
|
4.23 units on a scale
Standard Deviation 1.05
|
4.12 units on a scale
Standard Deviation 1.33
|
PRIMARY outcome
Timeframe: postoperative day 3Population: Intention-to-treat analysis. Data for this measure was collected for only 148 in the Exparel arm and 148 in the Regular Bupivacaine group.
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Outcome measures
| Measure |
Exparel®
n=148 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=148 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
|---|---|---|
|
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
|
4.37 units on a scale
Standard Deviation 0.99
|
4.37 units on a scale
Standard Deviation 1.11
|
PRIMARY outcome
Timeframe: postoperative day 1Population: Intention-to-treat analysis. Data for this measure was collected for only 142 in the Exparel arm and 140 in the Regular Bupivacaine group.
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
Outcome measures
| Measure |
Exparel®
n=142 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=140 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
|---|---|---|
|
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
|
5.49 units on a scale
Standard Deviation 2.51
|
5.41 units on a scale
Standard Deviation 2.52
|
PRIMARY outcome
Timeframe: postoperative day 2Population: Intention-to-treat analysis. Data for this measure was collected for only 151 in the Exparel arm and 149 in the Regular Bupivacaine group.
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
Outcome measures
| Measure |
Exparel®
n=151 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=149 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
|---|---|---|
|
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
|
4.48 units on a scale
Standard Deviation 2.38
|
4.4 units on a scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: postoperative day 3Population: Intention-to-treat analysis. Data for this measure was collected for only 150 in the Exparel arm and 135 in the Regular Bupivacaine group.
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
Outcome measures
| Measure |
Exparel®
n=150 Participants
Patients will receive will receive the study drug \[bupivacaine liposomal injectable suspension (Exparel®)\] and Patient Controlled Analgesia (PCA).
Exparel: Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
|
Regular Bupivacaine
n=135 Participants
Patients will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension.
Bupivacaine hydrochloride: Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA): Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
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|---|---|---|
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Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
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4 units on a scale
Standard Deviation 2.35
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3.53 units on a scale
Standard Deviation 3.6
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SECONDARY outcome
Timeframe: Over the first 72 hours after surgeryThe total amount in mg of opioid medication consumed through 12, 24, 36, 48, 60, and 72 hours after surgery will be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 4 weeksIndirect outcome measure to assess the adequacy of postoperative pain control as an indicator of improvement in healing period, patient participation in physical therapy and faster patient mobilization, and overall health care cost
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3The impact of pain on patient's quality of life will be assessed through a brief pain inventory (BPI). In addition, the 5-point scale analgesia satisfaction survey will be used along with the BPI to assess patient satisfaction and quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hours after surgeryOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of hospital stay, an expected average of 4 weeksHospital cost for patient care during hospitalization will be estimated from hospital charges and financial records.
Outcome measures
Outcome data not reported
Adverse Events
Exparel®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Regular Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kristofer M Charlton-Ouw
The University of Texas Health Science Center at Houston
Phone: (713) 486-5100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place