Pancreatic Carcinoma
Conditions
Brief 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.
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.
Interventions
OTHERBest Practice
Given standard of care
DRUGQuadratus Lumborum Block
Undergo QL block
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Discharged Opioid-Free | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Inpatient Oral Morphine Equivalents (OME) | Up to 1 year | Two sample t-test or Wilcoxon rank-sum test will be used. |
| Hospital Cost | Up to 1 year | Two sample t-test. |
| Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI) | Up to 1 year | Two sample t-test or Wilcoxon rank-sum test will be used. |
| Pain Prescription Dosage/Size | through study completion, an average of 1 year | Two sample t-test or Wilcoxon rank-sum test will be used. |
| Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg | Up to 1 year | Two sample t-test or Wilcoxon rank-sum test will be used. |
| MDASI-GI in Clinic Visits | Up to 1 year | Two sample t-test or Wilcoxon rank-sum test will be used. |
| Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient) | At 30 and 90 days | Two sample t-test or Wilcoxon rank-sum test will be used. |
| Patients and Family Free of Opioid Use | At 6 months and 1 year | Two sample t-test or Wilcoxon rank-sum test will be used. |
| Percentage of Patients Using Opioids | At 30 days after surgery | Two sample t-test or Wilcoxon rank-sum test will be used. |
Countries
United States
Participant flow
Pre-assignment details
30 participants were excluded from the study before assignment to arms due to aborted surgery, discharged before 4 days after surgery or opioids free at 3rd day after surgery.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1, Control Arm (Usual Care) Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. | 52 |
| Arm 2, Experimental Arm (2nd 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. | 53 |
| Total | 105 |
Baseline characteristics
| Characteristic | Total | Arm 1, Control Arm (Usual Care) | Arm 2, Experimental Arm (2nd QL-Block) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 59 Participants | 25 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 27 Participants | 19 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 11.8 | 63 years STANDARD_DEVIATION 12.5 | 65 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 44 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 94 Participants | 46 Participants | 48 Participants |
| Region of Enrollment United States | 105 participants | 52 participants | 53 participants |
| Sex: Female, Male Female | 47 Participants | 24 Participants | 23 Participants |
| Sex: Female, Male Male | 58 Participants | 28 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 52 | 3 / 54 |
| other Total, other adverse events | 39 / 52 | 31 / 54 |
| serious Total, serious adverse events | 10 / 52 | 10 / 54 |
Outcome results
Primary
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
Population: one participant inevaluable for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1, Control Arm (Usual Care) | Number of Participants Discharged Opioid-Free | 19 Participants |
| Arm 2, Experimental Arm (2nd QL-Block) | Number of Participants Discharged Opioid-Free | 27 Participants |
p-value: 0.17Chi-squared
Secondary
Hospital Cost
Two sample t-test.
Time frame: Up to 1 year
Secondary
MDASI-GI in Clinic Visits
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: Up to 1 year
Secondary
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
Secondary
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
Secondary
Percentage of Patients Using Opioids
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: At 30 days after surgery
Secondary
Percentage of Patients Using Opioids
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: At 90 days after surgery
Secondary
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
Secondary
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
Secondary
Total Inpatient Oral Morphine Equivalents (OME)
Two sample t-test or Wilcoxon rank-sum test will be used.
Time frame: Up to 1 year
Secondary
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