Repeat Quadratus Lumborum Block to Reduce Opioid Need in Patients After Pancreatic Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVE:
- 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 Design
Arms and Interventions
| 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: Best Practice
Given standard of care
Other Names:
Drug: Quadratus Lumborum Block
Undergo QL block
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| 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: Best Practice
Given standard of care
Other Names:
Drug: Quadratus Lumborum Block
Undergo QL block
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Proportion of opioid-free patients between the two arms [through study completion, an average of 1 year]
Will perform Chi-squared test.
Secondary Outcome Measures
- 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.
- Percentage of patients using opioids [At 30 days after surgery]
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.
- Percentage of patients using opioids [At 90 days after surgery]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Ching-Wei D Tzeng, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2018-0519
- NCI-2018-02182
- 2018-0519