Postoperative Analgesia Investigation

Pain Clinical Trial

— PAIN  

Official title:

A Prospective Randomized-controlled Study on Effectiveness of Extended-release Liposomal Bupivacaine in Postoperative Pain Control.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02474472
• Other study ID #: UT-PAIN-001
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 2013
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to compare the efficacy of standard local anesthetic bupivicaine and liposomal bupivicaine in postoperative pain control both in magnitude and duration in patients undergoing sternotomy, thoracotomy, thoracoabdominal, and laparotomy incisions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years-old or older, and

• Sternotomy, thoracotomy, laparotomy or thoracoabdominal 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

• The surgeon/anesthesiologist concludes that the period for intubation will be likely be for more than 24 hours after surgery

• There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• bupivacaine hydrochloride

• bupivacaine liposomal injectable suspension

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hosptial; Heart and Vascular Institute	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC) of Numeric Pain Scale		First 72 hours after procedure
Primary	Brief Pain Inventory Questionnaire		up to 30 postoperative days
Primary	5-point satisfaction scale		up to 30 postoperative days