Pain Management Techniques for Liver Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Narcotics, Anticoagulants

Disqualifiers: Uncontrolled disease, Neurologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two pain management techniques to determine which aids recovery better after liver surgery. Researchers compare thoracic epidural analgesia, which delivers pain medication through a small tube in the back, with a four-quadrant transversus abdominus plane block, where pain relief targets the abdominal muscles directly. It focuses on patients undergoing liver surgery for cancer without bowel surgery. Participants must sign a consent form and should not have had any recent major surgeries or chronic narcotic use. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking advancements in pain management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using therapeutic anticoagulation within 5 days of surgery and those with chronic narcotic use. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that thoracic epidural analgesia (TEA) is generally safe for patients undergoing liver surgery. Studies have found that it typically does not lead to serious complications like infections or blood clots in patients without major blood clotting issues. TEA is also preferred for controlling post-surgical pain. However, about one in four patients might not experience full pain relief if the epidural is not placed correctly.

For the four-quadrant transversus abdominus plane (TAP) block, research indicates it is safe and carries a low risk of causing liver injury, especially when guided by ultrasound. It also helps reduce the need for strong painkillers, such as opioids, after surgery.

Both TEA and TAP block effectively manage pain, with studies showing no major difference in pain relief between the two. This suggests that both options are generally safe and effective for pain management after liver surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these pain management techniques for liver surgery because they offer innovative ways to control pain effectively. The Four-Quadrant Transversus Abdominus Plane (TAP) Block uses an ultrasound-guided delivery of bupivacaine, including a long-lasting liposomal version, directly to the abdominal nerves, potentially providing better localized pain relief than traditional systemic painkillers. On the other hand, Thoracic Epidural Analgesia involves placing a catheter near the spine to administer hydromorphone and bupivacaine, offering continuous pain relief in a more targeted manner than oral or intravenous medications. These methods aim to enhance recovery, minimize opioid use, and improve overall patient comfort compared to current options like systemic opioids or standard epidural techniques.

What evidence suggests that this trial's treatments could be effective for pain management in liver surgery?

Research has shown that thoracic epidural pain relief, one of the treatments in this trial, works effectively after major surgeries, such as liver operations. It succeeds in 91% of patients and reduces the need for additional pain medication, like opioids. This method also leads to better outcomes compared to standard painkillers administered through an IV.

For the four-quadrant transversus abdominus plane (TAP) block, another treatment option in this trial, studies suggest it helps manage pain and reduces opioid use in abdominal surgeries. However, it does not significantly speed up recovery. Both methods show promise for reducing pain after liver surgery, with thoracic epidural being slightly more effective. ^{2 3 6 7 8}

Who Is on the Research Team?

Timothy Newhook, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients scheduled for open liver surgery at MD Anderson Cancer Center, without bowel resection. They must have normal blood clotting measures, no fever or infections that would interfere with epidural placement, and not be on chronic narcotics. Pregnant women or those unable to follow the study are excluded.

Inclusion Criteria

Platelets >= 100,000/ml (within 30 days of surgery)

International normalized ratio (INR) =< 1.5 (within 30 days of surgery)

Patients must sign a study-specific consent form

Exclusion Criteria

I have used narcotics daily for 30 days or more before my surgery.

I have a severe illness that makes liver surgery too risky for me.

Anaphylaxis to local anesthetics or narcotics

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Preparation

Patients undergo placement of thoracic epidural catheter or ultrasound-guided, four-quadrant transversus abdominus plane block before surgery

1 day

1 visit (in-person)

Surgery and Immediate Post-Operative Care

Patients receive pain management via thoracic epidural analgesia or TAP block during and after liver surgery

Up to 48 hours

Inpatient stay

Follow-up

Participants are monitored for safety, effectiveness, and recovery, including assessment of surgical complications and functional recovery

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Four-Quadrant Transversus Abdominus Plane Block
• Thoracic Epidural Analgesia

Trial Overview The study compares thoracic epidural analgesia and four-quadrant transversus abdominus plane block to see which method better reduces pain after liver surgery. The goal is to determine if one leads to quicker and more complete recovery.

How Is the Trial Designed?

Group I: Arm II (TAP) Experimental Treatment 4 Interventions

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

Group II: Arm I (TAE) Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Ultrasound-guided transversus abdominis plane (TAP) injections allow for more accurate placement of anesthetic, and this study found that increasing the volume of injected contrast (5, 10, 15, or 20 mL) correlates with greater spread in the abdominal wall, with 15 mL providing optimal coverage.

The study, conducted on 2 fresh frozen cadaver torsos, showed that 5 mL resulted in about 1 vertebral level of spread, while 10, 15, and 20 mL resulted in approximately 2 vertebral levels, indicating that larger volumes may enhance the effectiveness of the block, although results may vary in live patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transversus abdominis plane injection with computed tomography correlation: a cadaveric study. Moeschler, SM., Murthy, NS., Hoelzer, BC., et al.[2022]

In a study of 50 living liver donors, the use of a transversus abdominis plane (TAP) block significantly reduced postoperative morphine consumption, with patients receiving the block using an average of 40mg compared to 65mg in those who did not (P<0.05).

The TAP block also led to lower pain scores at rest and during movement at multiple time points post-surgery, indicating its effectiveness in providing analgesia after upper abdominal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transversus abdominis plane block for postoperative analgesia in living liver donors: A prospective, randomized, double-blinded clinical trial. Kıtlık, A., Erdogan, MA., Ozgul, U., et al.[2022]

In a systematic review of 6 randomized controlled trials involving 568 patients, the transversus abdominis plane (TAP) block was found to provide comparable pain control to thoracic epidural analgesia (TEA) after colorectal surgery, while also resulting in lower opioid consumption and fewer adverse events.

TAP block showed additional benefits in laparoscopic surgeries, including a shorter time to first flatus and a lower incidence of postoperative nausea and vomiting (PONV) compared to TEA, highlighting its advantages for minimally invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transversus abdominis plane block versus thoracic epidural analgesia in colorectal surgery: a systematic review and meta-analysis. Hamid, HKS., Marc-Hernández, A., Saber, AA.[2021]

In a study of 44 patients with ischemic heart disease undergoing abdominal surgery, low thoracic-epidural analgesia (TEA) was found to be more effective than the tranversus-abdominis plane (TAP) block, resulting in significantly lower morphine consumption and better pain control.

Patients receiving TEA experienced less pain at rest and during coughing compared to those receiving TAP block, although TEA was associated with a higher incidence of hypotension, indicating a trade-off between efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy and outcome of transversus-abdominis plane block versus low thoracic-epidural analgesia after laparotomy in ischemic heart disease patients. Wahba, SS., Kamal, SM.[2022]

The Transversus abdominis plane (TAP) block is an effective regional anesthesia technique that targets specific nerves to manage acute postoperative pain after abdominal surgery.

This case report explores the potential of TAP block in treating prolonged pain following upper abdominal surgery, suggesting its versatility beyond immediate postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guided TAP block for the treatment of postoperative prolonged pain - an alternative approach. Ekmekçi, P., Kazak Bengisun, Z., Kazbek, BK., et al.[2018]

The Transversus abdominis plane (TAP) block significantly reduces postoperative pain scores in patients undergoing lower abdominal surgeries, providing effective analgesia for the first 24 hours after surgery.

Patients receiving the TAP block requested their first rescue analgesic much later (265 minutes) compared to those who did not receive the block (66 minutes), indicating that TAP block not only reduces pain but also decreases the need for additional pain medication post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Transversus Abdominis Plane Block for Postoperative Analgesia in Different Lower Abdominal Surgeries in a Tertiary Care Hospital-Chengalpattu District. Manoharan, MM., Gnanadesikan, U., Elavarasan, K., et al.[2023]

In a study of 60 patients undergoing radical cystectomy, dexmedetomidine as an adjuvant to bupivacaine in TAP blocks provided significantly longer postoperative analgesia compared to fentanyl, with the first rescue analgesia occurring at an average of 8.90 hours versus 6.50 hours for fentanyl.

Patients receiving dexmedetomidine also required less total analgesic medication in the first 24 hours post-surgery (0.15 mg) compared to those receiving fentanyl (0.20 mg) and the control group (0.24 mg), indicating better pain management with lower opioid consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing radical cystectomy: a prospective randomised study. Kassim, DY., Mahmoud, HE., Fakhry, DM., et al.[2022]

In a study of 60 children aged 1 to 9 years undergoing unilateral lower abdominal surgeries, the ultrasound-guided transversus abdominis plane (TAP) block provided effective postoperative analgesia with a shorter time to first rescue analgesia (11.33 hours) compared to the caudal epidural block (13.18 hours).

Both the TAP block and caudal block groups had similar total postoperative opioid consumption, indicating that while the TAP block offered quicker pain relief, it did not require more opioids for effective pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of ultrasound-guided transversus abdominis plane block and caudal epidural block for postoperative analgesia in paediatric lower abdominal surgeries: A randomised controlled trial. Ranjan, V., Singh, S.[2023]

The transversus abdominis plane (TAP) block significantly reduced pain scores and tramadol requirements in the first 24 hours after major abdominal surgery in a study of 60 patients, indicating its effectiveness for postoperative analgesia.

No complications were reported from the TAP block, suggesting it is a safe method for providing pain relief following surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of postoperative analgesic efficacy of transversus abdominis plane block after abdominal surgery: A comparative study. Sharma, P., Chand, T., Saxena, A., et al.[2022]

The study involving 54 patients showed that a transversus abdominis plane (TAP) block using 0.5% bupivacaine significantly reduced postoperative pain intensity and the need for fentanyl after laparoscopic cholecystectomy compared to a saline control.

Adding sufentanil to the bupivacaine in the TAP block did not provide any additional benefits in pain relief or reduced fentanyl consumption, indicating that bupivacaine alone is effective for managing pain in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of transverse abdominis plane block in reduction of postoperation pain in laparoscopic cholecystectomy. Saliminia, A., Azimaraghi, O., Babayipour, S., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8841264/

Analgesic effects of ultrasound-guided fourquadrant ... The 4Q-TAP block enhanced multimodal analgesia and decreased opioid requirements in patients with CRS with HIPEC, but did not change postoperative recovery ...

2. journals.lww.com journals.lww.com/sjan/fulltext/2025/01000/comparison_of_analgesic_efficacy_of_continuous.8.aspx

Comparison of analgesic efficacy of continuous transversus... Transversus abdominis plane (TAP) block has been shown to be an effective analgesic modality for various abdominal surgeries.

3. anesth-pain-med.org anesth-pain-med.org/upload/pdf/apm-21094.pdf

quadrant transversus abdominis plane in patients with ... The 4Q-TAP group received a postoperative, ultra- sound-guided, four-quadrant TAP block, and the control group received an equivalent volume of normal ...

4. withpower.com withpower.com/trial/phase-3-bile-duct-diseases-9-2017-01d2f

Pain Management Techniques for Liver Surgery This phase III trial studies how well thoracic epidural analgesia or four-quadrant transversus abdominus plane block works in reducing pain in patients ...

5. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/am-pdf/10.1111/anae.15068

Epidural vs. transversus abdominis plane block for ... Our aim was to conduct a systematic review and meta-analysis to compare the analgesic efficacy, side effects and the functional outcomes of TAP block with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4870958/

The use of four-point transversus abdominis plane block for ... The safety profile of four TAP blocks is good with a dose limit of 200 mg in total. The risk of inadvertent liver injury is also minimum using the US for ...

7. brieflands.com brieflands.com/articles/aapm-12923

Subcostal Transverse Abdominis Plane Block for Acute ... There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions than the traditional transverse abdominis plane block.

8. nature.com nature.com/articles/s41598-022-25073-w

Transverse abdominis plane block compared with patient ... Our meta-analysis demonstrated there was no significant or clinically meaningful difference in the postoperative pain scores between TEA and TAP block group.