Clinical trial NCT03827291: QL Block With Exparel in Colectomy
Official title: Quantitative Observational Comparative Effectiveness of Quadratus Lumborum (QL) Block With Liposomal Bupivacaine (Exparel®) Versus Thoracic Epidural Analgesia in Patients Undergoing Laparoscopic Colectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparotomy
Colectomy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2019-02-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare efficacy of a quadratus lumborum block performed with liposomal bupivacaine for pain relief after laparoscopic colectomy compared to a historical cohort who received thoracic epidural analgesia.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if using a different type of injection of local anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a quadratus lumborum block) will improve pain control and be easier to manage after surgery than the current standard of care epidural (spinal injection) pain relief for patients undergoing laparoscopy colectomy.

Detailed description: Participants in this study will receive exparel via an abdominal muscle nerve block procedure immediately prior to their operation. Participants will be in this study for 96 hours following surgery, which is typically 3 days. During participation, the study staff will review participant's electronic health records for pain scores and pain medication needs.

Participants that receive the quadratus lumborum block, may experience improved pain control and/or reduced side effects compared to the epidural pain relief option, but it is not known yet whether this will be the case.

The most common risk is being sore in the flank where the block was placed. Other risks of the block rarely occur (less than .5-1%), these can include infection, allergy to the local anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac arrest.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective, laparoscopic colonic resection by one of three surgeons: Drs. Thacker, Mantyh or Migaly. These surgeons perform this procedure in the same manner
* Age 18-85 years
* American Society of Anesthesiologists (ASA) Physical Class I-III
* BMI 18-35 kg/m\^2

Exclusion Criteria:

* Inability to consent
* Inability to speak English
* Pregnancy
* Emergency surgery
* Contraindications to regional blockade: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
* Allergies/intolerances/contraindications to any of the multimodal agents (acetaminophen, gabapentin, ketorolac)
* Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
* History of drug or alcohol abuse
* Rheumatoid arthritis
* Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments of compliance

Primary outcomes:
measure: Cumulative opioid consumption over 48 hours
timeFrame: Opioid consumption from administration of Exparel to 48 hours post-administration
Secondary outcomes:
Other outcomes:
measure: 11-point Numeric Rating Scale (NRS-11)
timeFrame: 30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration
measure: Block success
timeFrame: 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration
measure: Adverse Events
timeFrame: From administration of Exparel through 168 hours post Exparel administration
measure: Satisfaction with postoperative pain control
timeFrame: From administration of Exparel through 48 hours post Exparel administration
measure: Hospital length of stay
timeFrame: From administration of Exparel through hospital discharge
measure: Incidence of opioid-related adverse events
timeFrame: From administration of Exparel through 168 hours post Exparel administration
measure: Time to first mobilization
timeFrame: From time of arrival in PACU through first mobilization
measure: Cost
timeFrame: From time of arrival in PACU through 96 hours post Exparel administration
measure: Sleep Quality
timeFrame: From administration of Exparel through 168 hours post Exparel administration
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Amanda Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: