Trial Outcomes & Findings for Study of Exparel Versus Epidural for Pain Control After Thoracotomy (NCT NCT02178553)

NCT ID: NCT02178553

Last Updated: 2020-01-09

Results Overview

Pain with cough documented using the numerical rating scale pain scores (0-10)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 102 participants
• Primary outcome timeframe: In the morning (8 am) on first postoperative day
• Results posted on: 2020-01-09

Participant Flow

Participant milestones

Measure	Epidural In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.	Intercostal Bupivicaine (Exparel) In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
Overall Study STARTED	53	49
Overall Study COMPLETED	45	39
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Measure	Epidural In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.	Intercostal Bupivicaine (Exparel) In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
Overall Study Did not proceed to open thoracotomy	7	3
Overall Study Physician Decision	0	4
Overall Study Technical problem with injection	1	3

Baseline Characteristics

Study of Exparel Versus Epidural for Pain Control After Thoracotomy

Baseline characteristics by cohort

Measure	Epidural n=45 Participants In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.	Intercostal Bupivicaine (Exparel) n=39 Participants In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.	Total n=84 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 12.5 • n=93 Participants	62.1 years STANDARD_DEVIATION 10.8 • n=4 Participants	61.9 years STANDARD_DEVIATION 11.7 • n=27 Participants
Sex: Female, Male Sex · Female	19 Participants n=93 Participants	21 Participants n=4 Participants	40 Participants n=27 Participants
Sex: Female, Male Sex · Male	26 Participants n=93 Participants	18 Participants n=4 Participants	44 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	43 Participants n=93 Participants	39 Participants n=4 Participants	82 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Body Mass Index	29.5 kg/m2 STANDARD_DEVIATION 6.1 • n=93 Participants	28.8 kg/m2 STANDARD_DEVIATION 7.4 • n=4 Participants	29.2 kg/m2 STANDARD_DEVIATION 6.7 • n=27 Participants

PRIMARY outcome

Timeframe: In the morning (8 am) on first postoperative day

Pain with cough documented using the numerical rating scale pain scores (0-10)

Outcome measures

Measure	Epidural n=45 Participants In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.	Intercostal Bupivicaine (Exparel) n=39 Participants In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
Pain Scores With Cough on First Postoperative Day	6.1 units on a scale Standard Deviation 2.7	6.9 units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: In the morning (8 am) on the second postoperative day

Pain with cough documented using the numerical rating scale pain scores (0-10). Zero indicates no pain, and 10 indicates the worst pain one could imagine.

Outcome measures

Measure	Epidural n=45 Participants In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.	Intercostal Bupivicaine (Exparel) n=39 Participants In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
Pain Scores With Cough on the Second Postoperative Day	5.2 score on a scale Standard Deviation 2.1	6.0 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Each morning for two days postoperative

NRS pain scores on a 0-10 scale at rest at 8 am on the first postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.

Outcome measures

Measure	Epidural n=45 Participants In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.	Intercostal Bupivicaine (Exparel) n=39 Participants In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
Pain Scores at Rest in the Morning on the First Postoperative Day	2.9 NRS pain score on a scale from 0-10 Standard Deviation 2.0	4.0 NRS pain score on a scale from 0-10 Standard Deviation 2.2

SECONDARY outcome

Timeframe: Each morning for two days postoperative

NRS pain scores on a 0-10 scale at rest in the morning on the second postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.

Outcome measures

Measure	Epidural n=45 Participants In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.	Intercostal Bupivicaine (Exparel) n=39 Participants In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
Pain Scores at Rest on the Second Postoperative Day	2.8 NRS pain scores on a scale from 0-10 Standard Deviation 1.9	3.2 NRS pain scores on a scale from 0-10 Standard Deviation 1.6

Adverse Events

Epidural

Serious events: 5 serious events

Other events: 3 other events

Deaths: 1 deaths

Intercostal Bupivicaine (Exparel)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Epidural n=46 participants at risk In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr. Epidural	Intercostal Bupivicaine (Exparel) n=39 participants at risk In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered. Intercostal Bupivicaine (Exparel)
Respiratory, thoracic and mediastinal disorders Respiratory failure	8.7% 4/46 • 3 months from the date of surgery	2.6% 1/39 • 3 months from the date of surgery
Surgical and medical procedures Prolonged hospital stay	2.2% 1/46 • 3 months from the date of surgery	2.6% 1/39 • 3 months from the date of surgery
Respiratory, thoracic and mediastinal disorders Pulmonary complications	0.00% 0/46 • 3 months from the date of surgery	5.1% 2/39 • 3 months from the date of surgery
Cardiac disorders Myocardial infarction	0.00% 0/46 • 3 months from the date of surgery	2.6% 1/39 • 3 months from the date of surgery

Other adverse events

Measure	Epidural n=46 participants at risk In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr. Epidural	Intercostal Bupivicaine (Exparel) n=39 participants at risk In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered. Intercostal Bupivicaine (Exparel)
Skin and subcutaneous tissue disorders Pruritis	6.5% 3/46 • 3 months from the date of surgery	0.00% 0/39 • 3 months from the date of surgery

Additional Information

Dr. James D. Hannon

Mayo Clinic Rochester

Phone: 507-284-7289

Email: hannon.james@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place