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Completed

NCT Number: NCT03827291

QL Block With Exparel in 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.

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Key information

Conditions

Laparotomy Colectomy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exparel

Drug

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.

Thoracic epidural analgesia

Other

Historical cohort that received thoracic epidural analgesia

Primary outcomes

  1. Cumulative Opioid Consumption Over 48 Hours

    Time frame: From arrival to PACU to 48 hours post-operatively

    Measured in morphine milligram equivalents.

Secondary outcomes

  1. Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)

    Time frame: 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

    The NRS-11 is an 11-point scale where 10=worst pain imaginable and 0= no pain.

Other outcomes

  1. Number of Participants With Block Success

    Time frame: 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration

    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.

  2. Number of Participants With Adverse Events Related to the Block

    Time frame: From administration of Exparel through 168 hours post Exparel administration

    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).

  3. Satisfaction With Postoperative Pain Control

    Time frame: Up to 48 hours post Exparel administration

    Overall subject satisfaction with pain control will be recorded on an 11-point scale: 10=highly satisfied, 0=completely unsatisfied.

  4. Hospital Length of Stay

    Time frame: From administration of Exparel through hospital discharge

    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).

  5. Number of Participants With Opioid-related Adverse Events

    Time frame: From administration of Exparel through 168 hours post Exparel administration

    Adverse events include nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression.

  6. Time to First Mobilization

    Time frame: From time of arrival in PACU through first mobilization

  7. Cost

    Time frame: From time of arrival in PACU through 96 hours post Exparel administration

    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.

  8. Sleep Quality as Measured by Two Questions

    Time frame: Up to 168 hours post Exparel administration

    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?"

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2019
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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