Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery

NCT03214510 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2016-1111NCI-2018-01124
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This phase III trial studies how well thoracic epidural analgesia or four-quadrant transversus abdominus plane block works in reducing pain in patients undergoing liver surgery. It is not yet known whether thoracic epidural analgesia or four-quadrant transversus abdominus plane block may help people to recover more completely and more quickly after surgery.

Conditions

Liver and Intrahepatic Bile Duct Disorder

Outcome Measures

Primary Outcomes (1)

• Total length of inpatient stay

  Will be recorded and compared between groups. Will be summarized using descriptive statistics including mean, standard deviation, median and range. Will be compared with 2-sample t- tests, Mann Whitney U tests or Wilcoxon rank sum tests as indicated.

  Up to 5 years

Secondary Outcomes (4)

• Early post-operative pain control

  Within 48 hours post surgery

• Complication rates secondary to the analgesic regimen

  Up to 5 years

• Surgical complication rates

  Up to 5 years

• Measures of functional recovery

  Up to 5 years

Other Outcomes (5)

• Time to readiness for RIOT (return to intended oncologic therapy)

  Up to 5 years

• Narcotic utilization

  Up to 5 years

• Compliance with ordering and delivery of Enhanced Recovery After Surgery program elements

  Up to 5 years

Study Arms (2)

Arm I (TAE)

EXPERIMENTAL

Patients undergo placement of thoracic epidural catheter before surgery. Patients receive hydromorphone hydrochloride and bupivacaine via thoracic epidural catheter every 10 minutes or 3 hours as needed. Patients may receive fentanyl and bupivacaine or plain bupivacaine via thoracic epidural catheter.

Drug: Bupivacaine; Drug: Fentanyl; Drug: Hydromorphone Hydrochloride; Device: Implanted Medical Device; Behavioral: Questionnaire

Arm II (TAP)

EXPERIMENTAL

Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.

Drug: Bupivacaine; Device: Implanted Medical Device; Drug: Liposomal Bupivacaine; Behavioral: Questionnaire

Interventions

Liposomal Bupivacaine DRUG

Given via TAP block

Also known as: Bupivacaine Liposome Injectable Suspension, Exparel

Arm II (TAP)

Questionnaire BEHAVIORAL

Ancillary studies

Also known as: Questionnaires

Arm I (TAE); Arm II (TAP)

Implanted Medical Device DEVICE

Undergo placement of thoracic epidural catheter

Also known as: IMPLANTED

Arm I (TAE)

Bupivacaine DRUG

Given via thoracic epidural catheter or TAP block

Also known as: AH 250

Arm I (TAE); Arm II (TAP)

Fentanyl DRUG

Given via thoracic epidural catheter

Also known as: Abstral, Duragesic

Arm I (TAE)

Hydromorphone Hydrochloride DRUG

Given via thoracic epidural catheter

Also known as: Dilaudid, Dilaudid HP, Dimorphone, Exalgo, Hydromorphone, Hydrostat, Hymorphan, Laudicon, Novolauden

Arm I (TAE)

Eligibility Criteria

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

You may qualify if:

• Patients undergoing open liver resection without bowel resection/anastomosis for malignancy at MD Anderson Cancer Center
• Patients must sign a study-specific consent form
• Platelets \>= 100,000/ml (within 30 days of surgery)
• International normalized ratio (INR) =\< 1.5 (within 30 days of surgery)
• Activated partial thromboplastin time (aPTT) =\< 40 (within 30 days of surgery)
• Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement

You may not qualify if:

• Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver surgery
• History of chronic narcotic use, defined as 30 days or more of preoperative daily narcotic use, measured from the date of surgery
• Anaphylaxis to local anesthetics or narcotics
• Previous or current neurologic disease affecting the lower hemithorax or below
• Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia
• Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion
• Use of therapeutic anticoagulation within 5 days of surgery (not including venous thromboembolism prophylaxis)
• Known bleeding diathesis or coagulopathy
• Psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barrier that would preclude accurate assessment of postoperative pain and/or ability to answer questionnaires (need to be able to read, comprehend, and answer questions)
• Inability to comply with study and/or follow-up procedures
• Patient refusal to participate in randomization
• Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent
• Patients with obvious unresectable disease prior to signing informed consent
• Patients with previous ventral hernia repair, cosmetic abdominoplasty or anterior abdominal wall reconstruction

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Bupivacaine; Fentanyl; Hydromorphone; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Timothy E. Newhook, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: October 4, 2017
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)