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

Phase 2

Active, not recruiting

Conditions: Pancreatic Carcinoma

Interventions: Other: Best Practice
Drug: Quadratus Lumborum Block
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

Registration Number: NCT03745794

Lead Sponsor: M.D. Anderson Cancer Center

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 136

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (QL block, standard of care)	Best Practice	Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
Arm I (QL block, standard of care)	Quadratus Lumborum Block	Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
Arm I (QL block, standard of care)	Questionnaire Administration	Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
Arm II (second QL block)	Quality-of-Life Assessment	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.
Arm I (QL block, standard of care)	Quality-of-Life Assessment	Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
Arm II (second QL block)	Best Practice	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.
Arm II (second QL block)	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.
Arm II (second QL block)	Quadratus Lumborum 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
MDASI-GI in Clinic Visits	Up to 1 year	Two sample t-test or Wilcoxon rank-sum test will be used.
Total Inpatient Oral Morphine Equivalents (OME)	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 90 days after surgery	Two sample t-test or Wilcoxon rank-sum test will be used.
Hospital Cost	Up to 1 year	Two sample t-test.
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.
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.