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

NCT03745794 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2018-0519NCI-2018-02182
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Total Inpatient Oral Morphine Equivalents (OME)

  Up to 1 year

• Hospital Cost

  Up to 1 year

• Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI)

  Up to 1 year

• Pain Prescription Dosage/Size

  through study completion, an average of 1 year

• Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg

  Up to 1 year

Study Arms (2)

Arm I (QL block, standard of care)

ACTIVE COMPARATOR

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

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

Arm II (second QL block)

EXPERIMENTAL

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; Drug: Quadratus Lumborum Block; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Given standard of care

Also known as: standard of care, standard therapy

Arm I (QL block, standard of care); Arm II (second QL block)

Quadratus Lumborum Block DRUG

Undergo QL block

Also known as: QL Block

Arm I (QL block, standard of care); Arm II (second QL block)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (QL block, standard of care); Arm II (second QL block)

Questionnaire Administration OTHER

Ancillary studies

Arm I (QL block, standard of care); Arm II (second QL block)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients with current or past substance (drug or alcohol) abuse disorder.
• Laparoscopic or minimally invasive surgery.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Results Point of Contact

• Title: Dr. Ching-Wei D. Tzeng, MD/Associate Professor, Surgical Oncology
• Organization: UT MD Anderson Cancer Center

cdtzeng@mdanderson.org

(713) 792-0386

Study Officials

• Ching-Wei D Tzeng

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 19, 2018
• Study Start: February 28, 2019
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 23, 2025
• Results First Posted: February 13, 2023

Record last verified: 2025-12

Locations

US (1)