Phase 4 N=343 Randomized Double-blind Treatment

PAIN - Postoperative Analgesia INvestigation

Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT02111746 ↗

Enrolled (actual)

343

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) — 5.05; 5.02 units on a scale — p=0.934

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Exparel (Drug); Bupivacaine hydrochloride (Drug); Patient Controlled Analgesia (PCA) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)	3.71; 3.03	0.014 sig
PRIMARY Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)	3.71; 3.03	0.014 sig
PRIMARY Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)	3.71; 3.03	0.014 sig
PRIMARY Postoperative Pain as Assessed by a Five-point Satisfaction Scale	4.37; 4.37	1
PRIMARY Postoperative Pain as Assessed by a Five-point Satisfaction Scale	4.37; 4.37	1
PRIMARY Postoperative Pain as Assessed by a Five-point Satisfaction Scale	4.37; 4.37	1
PRIMARY Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)	4; 3.53	0.202
PRIMARY Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)	4; 3.53	0.202
PRIMARY Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)	4; 3.53	0.202
SECONDARY Overall Opioid Use	—	—
SECONDARY Mean Length of Hospital Stay	—	—
SECONDARY Change From Baseline in Quality of Life	—	—
SECONDARY Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours	—	—
SECONDARY Hospital Cost for Patient Care During Hospitalization	—	—

Summary

The purpose of this study is to assess the efficacy of the intraoperative injection of prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical incisions.

Eligibility Criteria

Inclusion Criteria

18 years-old or older, and
Sternotomy, thoracotomy, laparotomy or mini-thoracotomy incision is planned
There is reasonable expectation that the patient will be extubated within 24 hours after surgery

Exclusion Criteria

The patient has a known allergy to morphine or any opioid
The patient has a known chronic pain disorder or takes daily opioid medication > 1 month prior to surgery
There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion
High postoperative morbidity index based on preoperative assessment, such as, low likelihood of extubation within 24 hours, extensive thoracoabdominal aortic aneurysm (Extent 2 TAAA), preoperative renal insufficiency/failure, etc.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02111746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.