Phase 4
Completed N=343
PAIN - Postoperative Analgesia INvestigation
Source: ClinicalTrials.gov NCT02111746 ↗Enrolled (actual)
343
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) — 5.05; 5.02 units on a scale — p=0.934
◆ Published Evidence
Established
37citations · ~7 / year
Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial.
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.
Linked Publications
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Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial.
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 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 |
| 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 |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT02111746) and the linked publication. 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. Informational only — not medical advice.