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Completed

NCT Number: NCT03745794

Repeat Quadratus Lumborum Block to Reduce Opioid Need in Patients After Pancreatic Surgery

This phase II trial studies how an additional anesthetic nerve block, called a quadratus lumborum block, works to reduce the need for opioids in patients after pancreatic surgery. Giving an additional regional anesthetic after surgery may hasten the weaning process, reduce the need for opioid medications upon discharge, and reduce the risk of opioid dependence.

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Key information

Conditions

Pancreatic Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVE:

I. To use a phase II randomized controlled trial to compare the intervention of a second regional anesthetic block (quadratus lumborum [QL] block) versus usual care (single intraoperative QL block) to increase the proportion of opioid-free pancreatic cancer survivors at discharge after potentially curative surgery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.

ARM 2: Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care.

After completion of study treatment, patients are followed up at 1 month, 3 months, 6 months, and 1 year after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing elective open pancreatic resection for potentially curative intent (pancreaticoduodenectomy or distal pancreatectomy) who would otherwise be treated with QL block + IV-PCA converted to oral pain meds (non-narcotic bundle + opioid pain pill).

Exclusion criteria

  • Patients with current or past substance (drug or alcohol) abuse disorder.
  • Laparoscopic or minimally invasive surgery.

Treatment and study plan

Best Practice

Other

Given standard of care

Other names: standard of care, standard therapy

Quadratus lumborum block

Drug

Undergo QL block

Other names: QL Block

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Number of Participants Discharged Opioid-Free

    Time frame: 90 days from surgery

    Performed Chi-squared test to compare the proportion of patients who were opioid-free on the discharge date between the two arms

Secondary outcomes

  1. Total Inpatient Oral Morphine Equivalents (OME)

    Time frame: Up to 1 year

    Two sample t-test or Wilcoxon rank-sum test will be used.

  2. Hospital Cost

    Time frame: Up to 1 year

    Two sample t-test.

  3. Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI)

    Time frame: Up to 1 year

    Two sample t-test or Wilcoxon rank-sum test will be used.

  4. Pain Prescription Dosage/Size

    Time frame: through study completion, an average of 1 year

    Two sample t-test or Wilcoxon rank-sum test will be used.

  5. Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg

    Time frame: Up to 1 year

    Two sample t-test or Wilcoxon rank-sum test will be used.

  6. Percentage of Patients Using Opioids

    Time frame: At 30 days after surgery

    Two sample t-test or Wilcoxon rank-sum test will be used.

  7. MDASI-GI in Clinic Visits

    Time frame: Up to 1 year

    Two sample t-test or Wilcoxon rank-sum test will be used.

  8. Percentage of Patients Using Opioids

    Time frame: At 90 days after surgery

    Two sample t-test or Wilcoxon rank-sum test will be used.

  9. Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient)

    Time frame: At 30 and 90 days

    Two sample t-test or Wilcoxon rank-sum test will be used.

  10. Patients and Family Free of Opioid Use

    Time frame: At 6 months and 1 year

    Two sample t-test or Wilcoxon rank-sum test will be used.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Pancreatectomy ("RESQU-BLOCK" Trial)

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2018
Registry last updated
Dec 23, 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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