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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Best Practice; Drug: Quadratus Lumborum Block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (QL block, standard of care); Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Given standard of care; Other Names: standard of care; standard therapy; Drug: Quadratus Lumborum Block; Undergo QL block; Other Names: QL Block
Experimental: Arm II (second QL block); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Given standard of care; Other Names: standard of care; standard therapy; Drug: Quadratus Lumborum Block; Undergo QL block; Other Names: QL Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Discharged Opioid-Free	Performed Chi-squared test to compare the proportion of patients who were opioid-free on the discharge date between the two arms	90 days from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Inpatient Oral Morphine Equivalents (OME)	Two sample t-test or Wilcoxon rank-sum test will be used.	Up to 1 year
Hospital Cost	Two sample t-test.	Up to 1 year
Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI)	Two sample t-test or Wilcoxon rank-sum test will be used.	Up to 1 year
Pain Prescription Dosage/Size	Two sample t-test or Wilcoxon rank-sum test will be used.	through study completion, an average of 1 year
Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg	Two sample t-test or Wilcoxon rank-sum test will be used.	Up to 1 year
Percentage of Patients Using Opioids	Two sample t-test or Wilcoxon rank-sum test will be used.	At 30 days after surgery
MDASI-GI in Clinic Visits	Two sample t-test or Wilcoxon rank-sum test will be used.	Up to 1 year
Percentage of Patients Using Opioids	Two sample t-test or Wilcoxon rank-sum test will be used.	At 90 days after surgery
Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient)	Two sample t-test or Wilcoxon rank-sum test will be used.	At 30 and 90 days
Patients and Family Free of Opioid Use	Two sample t-test or Wilcoxon rank-sum test will be used.	At 6 months and 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Ching-Wei D Tzeng, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Practice Guidelines as Topic
• Other Study ID Numbers: 2018-0519 (Other Identifier: M D Anderson Cancer Center); NCI-2018-02182 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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.: No