QL Block With Exparel in Colectomy

Quantitative Observational Comparative Effectiveness of Quadratus Lumborum (QL) Block With Liposomal Bupivacaine (Exparel®) Versus Thoracic Epidural Analgesia in Patients Undergoing Laparoscopic Colectomy.

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.

Study Overview

• Status: Completed
• Conditions: Laparotomy; Colectomy
• Intervention / Treatment: Drug: Exparel; Other: Thoracic epidural analgesia

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadratus lumborum block; 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.	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.	Other: Thoracic epidural analgesia; Historical cohort that received thoracic epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Opioid Consumption Over 48 Hours	Measured in morphine milligram equivalents.	From arrival to PACU to 48 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)	The NRS-11 is an 11-point scale where 10=worst pain imaginable and 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Participants With 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
Number of Participants With Adverse Events Related to the Block	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
Satisfaction With Postoperative Pain Control	Overall subject satisfaction with pain control will be recorded on an 11-point scale: 10=highly satisfied, 0=completely unsatisfied.	Up to 48 hours post Exparel administration
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
Number of Participants With Opioid-related Adverse Events	Adverse events include nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression.	From administration of Exparel through 168 hours post Exparel administration
Time to First Mobilization		From time of arrival in PACU through first mobilization
Sleep Quality as Measured by Two Questions	Each question has a scale of 0 (no interference) to 10 (completely interferes) and the two scores are averaged: "How much did pain interfere with falling asleep?", "How much did pain interfere with staying asleep?"	Up to 168 hours post Exparel administration

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Pacira Pharmaceuticals, Inc
• Investigators: Principal Investigator: Amanda Kumar, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): December 9, 2022

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Plant Preparations; Biological Products; Complex Mixtures; Tea
• Other Study ID Numbers: PRO00091425

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes