QL Block With Exparel in Colectomy

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03827291
• Other study ID #: PRO00091425
• Status: Completed
• Phase: Phase 4
• Start date: October 31, 2019
• Est. completion date: December 9, 2022

Study information

• Verified date: December 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Colectomy
• Laparotomy

Intervention

Drug:
• Exparel
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.

Other:
• Thoracic epidural analgesia
Historical cohort that received thoracic epidural analgesia

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

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