Clinical trial NCT03745794: Repeat Quadratus Lumborum Block to Reduce Opioid Need in Patients After Pancreatic Surgery
Official title: Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Pancreatectomy ("RESQU-BLOCK" Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants Discharged Opioid-Free
timeFrame: 90 days from surgery
Secondary outcomes:
measure: Total Inpatient Oral Morphine Equivalents (OME)
timeFrame: Up to 1 year
measure: Hospital Cost
timeFrame: Up to 1 year
measure: Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI)
timeFrame: Up to 1 year
measure: Pain Prescription Dosage/Size
timeFrame: through study completion, an average of 1 year
measure: Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg
timeFrame: Up to 1 year
measure: Percentage of Patients Using Opioids
timeFrame: At 30 days after surgery
measure: MDASI-GI in Clinic Visits
timeFrame: Up to 1 year
measure: Percentage of Patients Using Opioids
timeFrame: At 90 days after surgery
measure: Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient)
timeFrame: At 30 and 90 days
measure: Patients and Family Free of Opioid Use
timeFrame: At 6 months and 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ching-Wei D Tzeng
role: PRINCIPAL_INVESTIGATOR
References: