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

Pancreatic Carcinoma Clinical Trial

Official title:

Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Pancreatectomy ("RESQU-BLOCK" Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03745794
• Other study ID #: 2018-0519
• Secondary ID: NCI-2018-0218220
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 28, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: March 31, 2023
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Other:
• Best Practice
Given standard of care

Drug:
• Quadratus Lumborum Block
Undergo QL block

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	90 days from surgery
Secondary	Total Inpatient Oral Morphine Equivalents (OME)	Two sample t-test or Wilcoxon rank-sum test will be used.	Up to 1 year
Secondary	Hospital Cost	Two sample t-test.	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.	Up to 1 year
Secondary	Pain Prescription Dosage/Size	Two sample t-test or Wilcoxon rank-sum test will be used.	through study completion, an average of 1 year
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.	Up to 1 year
Secondary	Percentage of Patients Using Opioids	Two sample t-test or Wilcoxon rank-sum test will be used.	At 30 days after surgery
Secondary	MDASI-GI in Clinic Visits	Two sample t-test or Wilcoxon rank-sum test will be used.	Up to 1 year
Secondary	Percentage of Patients Using Opioids	Two sample t-test or Wilcoxon rank-sum test will be used.	At 90 days after surgery
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.	At 30 and 90 days
Secondary	Patients and Family Free of Opioid Use	Two sample t-test or Wilcoxon rank-sum test will be used.	At 6 months and 1 year

External Links

•   MD Anderson Cancer Center