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

Primary Purpose

Pancreatic Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Quadratus Lumborum Block
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (QL block, standard of care)

Arm II (second QL block)

Arm Description

Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total Inpatient Oral Morphine Equivalents (OME)
Two sample t-test or Wilcoxon rank-sum test will be used.
Hospital Cost
Two sample t-test.
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.
Pain Prescription Dosage/Size
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
Two sample t-test or Wilcoxon rank-sum test will be used.
Percentage of Patients Using Opioids
Two sample t-test or Wilcoxon rank-sum test will be used.
MDASI-GI in Clinic Visits
Two sample t-test or Wilcoxon rank-sum test will be used.
Percentage of Patients Using Opioids
Two sample t-test or Wilcoxon rank-sum test will be used.
Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient)
Two sample t-test or Wilcoxon rank-sum test will be used.
Patients and Family Free of Opioid Use
Two sample t-test or Wilcoxon rank-sum test will be used.

Full Information

First Posted
November 14, 2018
Last Updated
February 8, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03745794
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (QL block, standard of care)
Arm Type
Active Comparator
Arm Description
Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
Arm Title
Arm II (second QL block)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Given standard of care
Intervention Type
Drug
Intervention Name(s)
Quadratus Lumborum Block
Other Intervention Name(s)
QL Block
Intervention Description
Undergo QL block
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Number of Participants Discharged Opioid-Free
Description
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
Secondary Outcome Measure Information:
Title
Total Inpatient Oral Morphine Equivalents (OME)
Description
Two sample t-test or Wilcoxon rank-sum test will be used.
Time Frame
Up to 1 year
Title
Hospital Cost
Description
Two sample t-test.
Time Frame
Up to 1 year
Title
Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI)
Description
Two sample t-test or Wilcoxon rank-sum test will be used.
Time Frame
Up to 1 year
Title
Pain Prescription Dosage/Size
Description
Two sample t-test or Wilcoxon rank-sum test will be used.
Time Frame
through study completion, an average of 1 year
Title
Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg
Description
Two sample t-test or Wilcoxon rank-sum test will be used.
Time Frame
Up to 1 year
Title
Percentage of Patients Using Opioids
Description
Two sample t-test or Wilcoxon rank-sum test will be used.
Time Frame
At 30 days after surgery
Title
MDASI-GI in Clinic Visits
Description
Two sample t-test or Wilcoxon rank-sum test will be used.
Time Frame
Up to 1 year
Title
Percentage of Patients Using Opioids
Description
Two sample t-test or Wilcoxon rank-sum test will be used.
Time Frame
At 90 days after surgery
Title
Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient)
Description
Two sample t-test or Wilcoxon rank-sum test will be used.
Time Frame
At 30 and 90 days
Title
Patients and Family Free of Opioid Use
Description
Two sample t-test or Wilcoxon rank-sum test will be used.
Time Frame
At 6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Wei D Tzeng
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

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

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