Laparotomy Clinical Trial
Official title:
Quantitative Observational Comparative Effectiveness of Quadratus Lumborum (QL) Block With Liposomal Bupivacaine (Exparel®) Versus Thoracic Epidural Analgesia in Patients Undergoing Laparoscopic Colectomy.
Verified date | December 2022 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | December 9, 2022 |
Est. primary completion date | December 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Pacira Pharmaceuticals, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 11-point Numeric Rating Scale (NRS-11) | Two measures will be taken with each assessment, one at rest and one with coughing. (11-point scale: 10=worst pain imaginable, 0= no pain) | 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 | |
Other | Block success | Presence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels "sharp" or "dull", indicating block failure and success respectively. | 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration | |
Other | Adverse Events | Subjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block). | From administration of Exparel through 168 hours post Exparel administration | |
Other | Satisfaction with postoperative pain control | Overall subject satisfaction with pain control will be recorded on postoperative day 0 and 1 (11-point scale: 10=highly satisfied, 0=completely unsatisfied) | From administration of Exparel through 48 hours post Exparel administration | |
Other | Hospital length of stay | Measured both by raw length of stay and by time to achieving "discharge readiness", defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower). | From administration of Exparel through hospital discharge | |
Other | Incidence of opioid-related adverse events | Incidence of nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression | From administration of Exparel through 168 hours post Exparel administration | |
Other | Time to first mobilization | Time to first mobilization | From time of arrival in PACU through first mobilization | |
Other | Cost | Hospital costs including pharmacy-related costs, costs due to opioid-related adverse events, the cost associated with nursing interventions and drugs to treat opioid-related adverse events, and overall hospital admission costs will be calculated. | From time of arrival in PACU through 96 hours post Exparel administration | |
Other | Sleep Quality | Two measures will be taken for sleep quality assessment. How much did pain interfere with falling asleep ( 0= no interference, 10= completely interferes). How much did pain interfere with staying asleep (0= no interference, 10= completely interferes). Measures will be taken once daily from POD 1 to POD 7 (approximately 168hrs. after surgery). | From administration of Exparel through 168 hours post Exparel administration | |
Primary | Cumulative opioid consumption over 48 hours | Opioid consumption from administration of Exparel to 48 hours post-administration | Opioid consumption from administration of Exparel to 48 hours post-administration |
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