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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Pancreatic Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03745794

2018-0519 (Other Identifier)

NCI-2018-02182 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 2 patient groups

Arm I (QL block, standard of care)

Active Comparator group

Description:

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

Treatment:

Drug: Quadratus Lumborum Block

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Best Practice

Arm II (second QL block)

Experimental group

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.

Treatment:

Drug: Quadratus Lumborum Block

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Best Practice