An interventional study of liposomal bupivicaine in Pain, Postoperative, sponsored by United States Naval Medical Center, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by United States Naval Medical Center, San Diego · Not applicable, Interventional, and Treatment
Aim: To compare the postoperative outcomes after surgical infiltration with plain bupivacaine compared to liposomal bupivacaine in patients undergoing elective, minimally invasive, general surgery procedures. To the investigators knowledge, there are no head-to-head, prospective, randomized, controlled trials of plain bupivacaine versus liposomal bupivacaine to evaluate postoperative pain and return of function.
The investigators current standard has been to use liposomal bupivacaine routinely for surgical infiltration which was a change from the historical practice of infiltration with lidocaine/bupivacaine, plain bupivacaine or no local anesthetic at all. The change was made due to the perceived benefits in analgesia past the 12-24 hours that plain bupivacaine was effective. It is not clear, however, that there are statistically significant benefits in terms of reduced narcotic use and length of hospital stay and improved pain control and return of function post-operatively.
Primary outcomes: The investigators will then measure narcotic use post-operatively as calculated by combining measures of patient-controlled analgesia (PCA) use for first 24 hours added to in-patient oral narcotic use (by referencing the electronic medical record (EMR)) as well as out-patient oral narcotic use as reported by patients. Subjective pain levels and pain interference scale and physical functioning scale will be evaluated pre-operatively and post-operatively with use of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) developed by the Defense and Veterans Center for Integrative Pain Management (DVCIPM) as a measure of perioperative pain and function.
5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 100 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →United States Naval Medical Center, San Diego is the lead sponsor of 65 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Post procedure, infiltrate wounds with liposomal bupivacaine 1. Liposomal Bupivacaine (Brand name Exparel) 266 milligram (mg)/20 mL to be diluted to 30 mL with normal saline 2. 10 mL of study drug to be injected at each 10-12 millimeter (mm) trocar site and 5 mL of study drug to be injected at the 5 mm trocar sites. Typically there are two 10 mm trocar sites and three 5 mm trocar sites.
Drug: liposomal bupivicaine
1. Post procedure, infiltrate wounds with plain bupivicaine 2. Plain Bupivacaine 0.25%, volume of 30 mL 3. 10 mL of study drug to be injected at each 10-12 millimeter (mm) trocar site and 5 mL of study drug to be injected at the 5 mm trocar sites. Typically there are two 10 mm trocar sites and three 5 mm trocar sites.
Drug: liposomal bupivicaine
1. The intervention that is being tested and who will perform the procedures; Two general surgeons will perform the procedure with either liposomal or plain bupivacaine. 2. The treatment procedures or regimens; The treatment procedure is direct, surgical site infiltration with either liposomal or plain bupivacaine. 3. Dosage level and justification; Liposomal Bupivacaine: 266 mg/20 mL liposomal bupivacaine diluted to 30 mL Plain Bupivacaine: 30 mL of 0.5% plain bupivacaine 4. Route of drug administration; Surgical site infiltration
Also known as: Exparel
Total post operative narcotic use in morphine equivalents.
To be measured by combining measures of Patient-Controlled Analgesia pump use for the first 24 hours added to in-patient oral narcotic use (by referencing the electronic medical record (EMR) and out-patient oral narcotic use as reported by patients.
Time frame: Up to fourteen days.
Length of hospital stay post operative procedure.
Participants post operative procedure length of stay will be determined from the electronic medical record.
Time frame: up to fourteen days.
Pain level pre and post operative procedure.
Baseline pain level will be gathered pre operative procedure and post operative procedure day one, seven, and fourteen through the 0 to 10 pain scale with 0 being "No Pain", 5 being "Moderate Pain", and 10 being "Worse Possible Pain".
Time frame: Up to fourteen days.
Post operative procedure physical functioning level.
Data is gathered on POP day one, seven and fourteen through the Physical Functioning Scale (PFS), which is scored from 0 to 100 with a higher scores indicating better physical function.
Time frame: Up to fourteen days.
Number of post operative procedure adverse events.
Data is gathered from the patient electronic medical record (EMR).
Time frame: Up to fourteen days.
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2015 to primary completion in Jan 2020, 49 months.
Of 1,888 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 49 months is above that.
Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
United States Naval Medical Center, San Diego