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

Primary Purpose

Liver and Intrahepatic Bile Duct Disorder

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Fentanyl
Hydromorphone Hydrochloride
Implanted Medical Device
Implanted Medical Device
Liposomal Bupivacaine
Questionnaire
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver and Intrahepatic Bile Duct Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (TAE)

Arm II (TAP)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Early post-operative pain control
The area under the curve for each patient will be computed using the trapezoidal method using the pain score by time curve as has been done in prior studies of this type at MD Anderson. Will be compared between groups. In addition, the number of patients experiencing severe pain (>= 7/10) during the inpatient recovery period will be compared between study 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.
Complication rates secondary to the analgesic regimen
Pain control modality complications will be prospectively recorded including epidural hematoma, epidural catheter migration/malfunction, injection/exit site cellulitis, epidural abscess, cerebrospinal fluid leak, prolonged ileus (defined as inability to tolerate regular diet by post operation day 5), imbalance and gait instability, altered mental status and delirium, and need to change pain control modality due to inadequate pain control. The rate of these complications will be compared between study groups. Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated.
Surgical complication rates
Postoperative surgical complications will be prospectively recorded and graded using the Accordian grading scale. Liver surgery specific complications including bile fistula, bleeding requiring transfusion and liver failure will be recorded. 30-day readmission and 90-day mortality will be recorded. The rates of these complications will be compared between study groups. Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated.
Measures of functional recovery
Quality of recovery will be assessed using the MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) at regimented intervals including preoperative baseline and postoperative inpatient and outpatient recovery, Return to baseline symptoms including return to baseline life interference summary score at 6 weeks postoperatively, measured using the MDASI-GI, will be compared between groups. Likewise, pre- and post-operative physical and cognitive performance recovery will be 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.

Full Information

First Posted
July 7, 2017
Last Updated
August 16, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03214510
Brief Title
Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery
Official Title
Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVE: I. To compare length of hospital stay between patients treated with thoracic epidural analgesia (TEA) versus (vs.) pre-incision ultrasound-guided, four-quadrant transversus abdominus plane (TAP) block after open liver resection within an enhanced recovery program. SECONDARY OBJECTIVES: I. To compare the area under the curve of early (0-48 hour) post-operative pain scores and number of patients who experience severe postoperative pain between the TEA and TAP groups. II. To compare anesthetic-related complication rates and need to change modalities between TEA and TAP groups. III. To compare surgery-related complications (including 30-day readmission and 90-day mortality rates) between TEA and TAP groups. IV. To compare return to baseline symptom burden, functional and cognitive status between TEA and TAP groups. OUTLINE: Patients are randomized into 1 of 2 arms. ARM I: 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. ARM II: Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver and Intrahepatic Bile Duct Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (TAE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (TAP)
Arm Type
Experimental
Arm Description
Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
AH 250
Intervention Description
Given via thoracic epidural catheter or TAP block
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Abstral, Duragesic
Intervention Description
Given via thoracic epidural catheter
Intervention Type
Drug
Intervention Name(s)
Hydromorphone Hydrochloride
Other Intervention Name(s)
Dilaudid, Dilaudid HP, Dimorphone, Exalgo, Hydromorphone, Hydrostat, Hymorphan, Laudicon, Novolauden
Intervention Description
Given via thoracic epidural catheter
Intervention Type
Device
Intervention Name(s)
Implanted Medical Device
Other Intervention Name(s)
IMPLANTED
Intervention Description
Undergo placement of thoracic epidural catheter
Intervention Type
Device
Intervention Name(s)
Implanted Medical Device
Other Intervention Name(s)
IMPLANTED
Intervention Description
Undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Other Intervention Name(s)
Bupivacaine Liposome Injectable Suspension, Exparel
Intervention Description
Given via TAP block
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
Questionnaires
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Total length of inpatient stay
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Early post-operative pain control
Description
The area under the curve for each patient will be computed using the trapezoidal method using the pain score by time curve as has been done in prior studies of this type at MD Anderson. Will be compared between groups. In addition, the number of patients experiencing severe pain (>= 7/10) during the inpatient recovery period will be compared between study 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.
Time Frame
Within 48 hours post surgery
Title
Complication rates secondary to the analgesic regimen
Description
Pain control modality complications will be prospectively recorded including epidural hematoma, epidural catheter migration/malfunction, injection/exit site cellulitis, epidural abscess, cerebrospinal fluid leak, prolonged ileus (defined as inability to tolerate regular diet by post operation day 5), imbalance and gait instability, altered mental status and delirium, and need to change pain control modality due to inadequate pain control. The rate of these complications will be compared between study groups. Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated.
Time Frame
Up to 5 years
Title
Surgical complication rates
Description
Postoperative surgical complications will be prospectively recorded and graded using the Accordian grading scale. Liver surgery specific complications including bile fistula, bleeding requiring transfusion and liver failure will be recorded. 30-day readmission and 90-day mortality will be recorded. The rates of these complications will be compared between study groups. Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated.
Time Frame
Up to 5 years
Title
Measures of functional recovery
Description
Quality of recovery will be assessed using the MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) at regimented intervals including preoperative baseline and postoperative inpatient and outpatient recovery, Return to baseline symptoms including return to baseline life interference summary score at 6 weeks postoperatively, measured using the MDASI-GI, will be compared between groups. Likewise, pre- and post-operative physical and cognitive performance recovery will be 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.
Time Frame
Up to 5 years
Other Pre-specified Outcome Measures:
Title
Time to readiness for RIOT (return to intended oncologic therapy)
Description
Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated. To assess the relationship between study variables and time to event outcomes (such as RIOT), Kaplan-Meier plots and log-rank tests will be used.
Time Frame
Up to 5 years
Title
Narcotic utilization
Description
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.
Time Frame
Up to 5 years
Title
Compliance with ordering and delivery of Enhanced Recovery After Surgery program elements
Description
Will be tabulated with frequency and percentages. Will be compared using chi-square test with Fisher's correction as indicated.
Time Frame
Up to 5 years
Title
Cost of perioperative care
Description
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.
Time Frame
Up to 5 years
Title
Biologic inflammatory markers
Description
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.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy E. Newhook, MD
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy E. Newhook
Phone
713-792-6940
Email
tnewhook@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Timothy E. Newhook

12. IPD Sharing Statement

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

Learn more about this trial

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

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