A Phase 2 interventional study of Best Practice and Quadratus Lumborum Block in Pancreatic Carcinoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 136 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
Other: Best Practice · Drug: Quadratus Lumborum Block · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
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: Best Practice · Drug: Quadratus Lumborum Block · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Given standard of care
Also known as: standard of care, standard therapy
Undergo QL block
Also known as: QL Block
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
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
Time frame: 90 days from surgery
Total Inpatient Oral Morphine Equivalents (OME)
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: Up to 1 year
Hospital Cost
Two sample t-test.
Time frame: 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.
Time frame: Up to 1 year
Pain Prescription Dosage/Size
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: 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.
Time frame: Up to 1 year
Percentage of Patients Using Opioids
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: At 30 days after surgery
MDASI-GI in Clinic Visits
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: Up to 1 year
Percentage of Patients Using Opioids
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: 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.
Time frame: At 30 and 90 days
Patients and Family Free of Opioid Use
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: At 6 months and 1 year
| Milestone | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| Started | 52 | 54 |
| Completed | 52 | 53 |
| Not completed | 0 | 1 |
Performed Chi-squared test to compare the proportion of patients who were opioid-free on the discharge date between the two arms
| Participants | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| Number of Participants Discharged Opioid-Free | 19 | 27 |
Two sample t-test or Wilcoxon rank-sum test will be used.
Results for this outcome have not been posted.
Two sample t-test.
Results for this outcome have not been posted.
Two sample t-test or Wilcoxon rank-sum test will be used.
Results for this outcome have not been posted.
Two sample t-test or Wilcoxon rank-sum test will be used.
Results for this outcome have not been posted.
Two sample t-test or Wilcoxon rank-sum test will be used.
Results for this outcome have not been posted.
Two sample t-test or Wilcoxon rank-sum test will be used.
Results for this outcome have not been posted.
Two sample t-test or Wilcoxon rank-sum test will be used.
Results for this outcome have not been posted.
Two sample t-test or Wilcoxon rank-sum test will be used.
Results for this outcome have not been posted.
Two sample t-test or Wilcoxon rank-sum test will be used.
Results for this outcome have not been posted.
Two sample t-test or Wilcoxon rank-sum test will be used.
Results for this outcome have not been posted.
Collected over 90 days from surgery. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1, Control Arm (Usual Care) | 3/52 (5.8%) | 10/52 (19.2%) | 39/52 (75%) |
| Arm 2, Experimental Arm (2nd QL-Block) | 3/54 (5.6%) | 10/54 (18.5%) | 31/54 (57.4%) |
| Event | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| Pancreatic leakGastrointestinal disorders | 4/52 | 2/54 |
| GI OtherGastrointestinal disorders | 3/52 | 2/54 |
| SepsisInfections and infestations | 2/52 | 0/54 |
| Chyle leakGastrointestinal disorders | 0/52 | 2/54 |
| AbscessInfections and infestations | 1/52 | 2/54 |
| BJ leakGastrointestinal disorders | 1/52 | 0/54 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/52 | 0/54 |
| Hematologic_ otherBlood and lymphatic system disorders | 1/52 | 0/54 |
| Sterile collectionInfections and infestations | 1/52 | 0/54 |
| Delayed Gastric EmptyingGastrointestinal disorders | 0/52 | 1/54 |
| Event | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|
| GI OtherGastrointestinal disorders | 9/52 | 3/54 |
| Delayed Gastric EmptyingGastrointestinal disorders | 8/52 | 7/54 |
| Pancreatic leakGastrointestinal disorders | 8/52 | 7/54 |
| Wound infectionInfections and infestations | 7/52 | 2/54 |
| Infectious OtherInfections and infestations | 6/52 | 1/54 |
| Post-op transfusionBlood and lymphatic system disorders | 4/52 | 5/54 |
| Chyle leakGastrointestinal disorders | 2/52 | 4/54 |
| Renal otherRenal and urinary disorders | 3/52 | 3/54 |
| CholangitisInfections and infestations | 3/52 | 1/54 |
| ArrythmiaCardiac disorders | 2/52 | 0/54 |
| Age, Categorical(Participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 19 | 46 |
| >=65 years | 25 | 34 | 59 |
| Age, Continuous(years) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| Mean | 63 ± 12.5 | 65 ± 11.2 | 64 ± 11.8 |
| Sex: Female, Male(Participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| Female | 24 | 23 | 47 |
| Male | 28 | 30 | 58 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 2 | 8 |
| Not Hispanic or Latino | 44 | 49 | 93 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 5 |
| White | 46 | 48 | 94 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) | Total |
|---|---|---|---|
| United States | 52 | 53 | 105 |
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M.D. Anderson Cancer Center