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Phase 2 N=106 Randomized Triple-blind Treatment

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

Pancreatic Carcinoma

Enrolled (actual)
106
Serious AEs
18.9%
Results posted
Feb 2023
Primary outcome: Primary: Number of Participants Discharged Opioid-Free — 19; 27 Participants — p=0.17

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Best Practice (Other); Quadratus Lumborum Block (Drug); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
M.D. Anderson Cancer Center
Primary completion
Jul 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Discharged Opioid-Free
19; 27 0.17
SECONDARY
Total Inpatient Oral Morphine Equivalents (OME)
SECONDARY
Hospital Cost
SECONDARY
Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI)
SECONDARY
Pain Prescription Dosage/Size
SECONDARY
Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg
SECONDARY
Percentage of Patients Using Opioids
SECONDARY
MDASI-GI in Clinic Visits
SECONDARY
Percentage of Patients Using Opioids
SECONDARY
Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient)
SECONDARY
Patients and Family Free of Opioid Use

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03745794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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