Clinical trial NCT03305666: Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
Official title: A Randomized Clinical Trial of Single Dose Liposomal Bupivacaine Delivered Via VATS Intercostal Nerve Block vs. Continuous Bupivacaine Infusion Delivered Via Indwelling Subscapular Catheter After Surgical Stabilization of Rib Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Effect
Rib Fractures
Rib Trauma
Surgical Procedure, Unspecified
Pain; Catheter (Other)
Nerve Pain
Local Infiltration
Anesthesia, Local
Intercostal Rib
Opioid Dependence
Chest Injury Trauma
Pneumonia
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority, randomized, clinical trial
Primary purpose: TREATMENT

Brief summary: Rib fractures represent a common injury pattern this is highly associated with patient morbidity and mortality, as pain control remains a challenge. Even after surgical stabilization of rib fractures (SSRF), unsuccessful pain control can lead to morbid outcomes such as pneumonia and opioid dependence. Multi-modal anesthesia, with the use of thoracic epidurals and para-vertebral injections/catheters, has shown to lessen these occurrences but are subject to a wide array of limitations. A more directed therapy with liposomal bupivacaine has shown to provide sustained analgesia for up to 72 hours in patients who have undergone other types of thoracic surgery, but not SSRF. The hypothesis of the current clinical trial is that, among patients undergoing SSRF, liposomal bupivacaine delivered via video assisted thoracic surgery (VATS) is an intercostal nerve block that provides comparable analgesia to the pain catheter, as measured by pulmonary function, numeric pain scoring, and postoperative narcotic use.

Detailed description: Rib fractures represent a common injury pattern with high associated morbidity and mortality. Effective pain control in both the acute and long term periods remains a challenge. Surgical stabilization of rib fractures (SSRF) is now a recommended treatment for patients with severe chest wall injuries. In addition to stabilization of the chest wall, SSRF offers a unique opportunity to deliver directed, loco-regional anesthesia. Loco-regional anesthesia is a recognized, essential component of multi-modal anesthesia for patients with rib fractures in order to both decrease pain and minimize the use of opioids and their associated side effects.

Delivery options for loco-regional anesthesia to patients with rib fractures share in common the intention of anesthetizing the intercostal nerves. Moving from the spinal cord laterally, modalities include thoracic epidural catheters, paravertebral blocks or catheters, and rib/intercostal blocks. Although rib blocks may be accomplished via a variety of techniques, the two most common intra-operative techniques are video-assisted thoracoscopic surgery (VATS) intercostal nerve blocks and indwelling, subscapular catheters In general, neuraxial modalities such as thoracic epidural and para-vertebral injections/catheters are subject to a wide array of limitations, including patient coagulopathy (International Normalized Ratio \> 1.5), co-existing spine fractures, peri-insertion, peri-removal withholding of venous thromboembolism pharmacoprophylaxis, and provider availability. For these reasons, our current practice is to insert a subscapular "pain catheter" at the conclusion of the SSRF operation; this catheter is able to deliver a continuous infusion of 0.25% bupivacaine and may be left in place for several days.

Although favorable results using the pain catheter have been published in patients with rib fractures who have not undergone SSRF, we have noticed several limitations to this treatment modality. First, position is highly variable; and, because the catheter is not truly in the space of the intercostal nerves, drug delivery is likely irregular. This variability may be particularly relevant in obese patients; and the median body mass index of patient who underwent SSRF at Denver Health is 29 kg/m\^2. Beyond catheter placement, we have also experienced issues with leakage of drug from the skin entry site of the catheter. Moreover, catheters frequently become dislodged or inadvertently removed during patient transport. Further, the indwelling foreign body likely introduces some risk of infection. Finally, the presence of the catheter is distressing to many patients.

Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Inc., Parsippany, NJ, www.pacira.com) has been shown to provide sustained analgesia for up to 72 hours following a single injection of the drug delivery system. The safety and efficacy of liposomal bupivacaine has been evaluated in over 1,300 subjects and 21 clinical trials. Although many of these trials have included thoracic surgery patients, no trial has evaluated the efficacy and safety of liposomal bupivacaine administered to patients with rib fractures undergoing SSRF. Potential benefits as compared to current practice include directed injection immediately adjacent to the intercostal nerve using a VATS approach, as well as obviation of the need for an indwelling catheter. The hypothesis of the current clinical trial is that, among patients undergoing SSRF, liposomal bupivacaine delivered via video assisted thoracic surgery (VATS) is an intercostal nerve block that provides comparable analgesia to the pain catheter, as measured by pulmonary function, numeric pain scoring, and postoperative narcotic use.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing SSRF at Denver Health Medical Center

Exclusion Criteria:

* Allergy or hypersensitivity to bupivacaine
* Pregnancy
* Incarceration
* Age \< 18 years
* Indwelling continuous thoracic epidural analgesia

Primary outcomes:
measure: Daily Sequential Clinical Assessment of Respiratory Function (SCARF) Score
timeFrame: Median SCARF scores were recorded for the first 5 postoperative days.
Secondary outcomes:
measure: Daily Narcotic Requirements Using Equi-analgesic Doses
timeFrame: Mean narcotic requirement scores were recorded for the first 5 postoperative hospital inpatient days.
measure: Percentage of Participants Experiencing Failure of Primary Loco-Regional Analgesia (LRA)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: Denver Health and Hospital
name: Fredric Pieracci, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leasia KN, Ciarallo C, Prins JTH, Preslaski C, Perkins-Pride E, Hardin K, Cralley A, Burlew CC, Coleman JJ, Cohen MJ, Lawless R, Platnick KB, Moore EE, Pieracci FM. A randomized clinical trial of single dose liposomal bupivacaine versus indwelling analgesic catheter in patients undergoing surgical stabilization of rib fractures. J Trauma Acute Care Surg. 2021 Nov 1;91(5):872-878. doi: 10.1097/TA.0000000000003264.