Pain Management for Cancer Surgery

(LapTAP Trial)

Overseen By AHN Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Must not be taking: Opioids, Analgesics

Disqualifiers: Hepatic dysfunction, Chronic pain, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three methods to manage pain during minimally invasive cancer surgeries. The treatments compared include LapTAP (Laparoscopic Transversus Abdominis Plane Block, a pain relief technique using targeted anesthetic blocks) with or without a local anesthetic, and a local anesthetic alone. Researchers aim to determine which option best controls pain, requires the least medication, and causes the fewest side effects. Individuals scheduled for elective cancer surgeries, such as those involving the liver or stomach, who can communicate their pain levels, may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management strategies for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on long-term opioid or pain medication, you may not be eligible to participate.

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

A previous study found the Laparoscopic Transversus Abdominis Plane Block (LapTAP) to be safe and effective, particularly for abdominal surgeries. This technique manages pain by numbing nerves in the belly area. Research shows that patients tolerate it well with few side effects.

Research indicates that local anesthetics, used to numb specific areas, are generally safe. They are commonly used in surgeries and have a strong safety record, with patients usually experiencing only minor side effects, if any.

Both treatments used in the trial have undergone prior study and are considered safe for managing pain during surgery. Participants might expect typical, mild reactions, but serious issues are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pain management techniques for cancer surgery because they explore different ways to deliver anesthesia effectively. The Laparoscopic Transversus Abdominis Plane (TAP) Block stands out because it involves numbing a specific area of nerves using a minimally invasive approach, which may lead to better pain control and quicker recovery compared to traditional methods like general anesthesia. When combined with local anesthetics, it could provide enhanced pain relief with potentially fewer side effects. These techniques offer the possibility of improving patient comfort and reducing reliance on opioids, which is a major concern in post-surgical pain management.

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

Research shows that the Laparoscopic Transversus Abdominis Plane Block (LapTAP), one of the treatments in this trial, effectively reduces pain after minimally invasive surgeries. Studies indicate that it leads to lower pain levels, and patients often require fewer pain medications. This suggests that LapTAP may aid in a more comfortable and quicker recovery after surgery. Local anesthetics, another treatment option in this trial, provide strong pain relief during and after cancer surgeries and reduce the risk of long-term pain issues. Overall, both treatments have proven effective in managing pain in surgical patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Casey Allen, MD

Principal Investigator

Allegheny Health Network

Are You a Good Fit for This Trial?

This trial is for patients with various abdominal cancers (like liver, stomach, pancreatic) who are undergoing minimally invasive surgery. Participants must be eligible for the surgical procedures and willing to have their pain management method chosen randomly.

Inclusion Criteria

My upcoming medical procedure is expected to last between 1 and 8 hours.

Patients who have provided informed consent to participate in the study

I am scheduled for a minimally invasive cancer surgery in my liver, stomach, bile ducts, pancreas, reproductive organs, or GI tract.

Exclusion Criteria

I am either younger than 18 or 90 years old or older.

I have liver problems or cirrhosis.

My health is severely limited by my illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo minimally invasive oncologic surgery with one of three pain management regimens: LapTAP with LA, LapTAP only, or LA only

Surgery day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for pain scores, opioid consumption, and adverse events for 24 hours post-surgery

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment until discharge

Up to 1 week

What Are the Treatments Tested in This Trial?

Interventions

• Laparoscopic Transversus Abdominis Plane Block
• Local Anesthesia

Trial Overview The study compares three pain control methods during cancer surgery: a Laparoscopic Transversus Abdominis Plane Block with local anesthesia, the block without anesthesia, and local anesthesia alone. Patients will receive standard care and their pain levels will be monitored post-surgery.

How Is the Trial Designed?

Group I: Laparoscopic Transversus Abdominis Plane Block with Local Anesthetic Active Control 2 Interventions

Patient would be receiving Laparoscopic Transversus Abdominis Plane block in addition to Local Anesthetic per standard of care.

Group II: Laparoscopic Transversus Abdominis Plane block only Active Control 1 Intervention

Patient would be receiving Laparoscopic Transversus Abdominis Plane block without Local Anesthetic per standard of care.

Group III: Local Anesthetic only Active Control 1 Intervention

Patient would be receiving Local Anesthetic per standard of care.

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials

52

Recruited

13,000+

Published Research Related to This Trial

In a study of 66 women undergoing total abdominal hysterectomy, the combination of a transversus abdominis plane block with general anesthesia significantly reduced the consumption of opioids (remifentanil) and anesthetics (sevoflurane), indicating a more efficient pain management strategy.

Patients receiving the transversus abdominis plane block reported significantly lower pain scores and higher quality of recovery scores in the postoperative period, suggesting improved outcomes compared to those who only received general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effects of transversus abdominis plane block on analgesic and anesthetic consumption during total abdominal hysterectomy: a randomized controlled study]. Karaman, T., Ozsoy, AZ., Karaman, S., et al.[2022]

In a randomized trial involving 79 patients undergoing midline laparotomy, surgeon-administered transversus abdominis plane block with bupivacaine did not significantly reduce opioid requirements compared to a placebo, with both groups requiring similar amounts of morphine in the first 24 hours post-surgery.

The study found no differences in pain scores, incidence of nausea and vomiting, or other postoperative outcomes between the bupivacaine and placebo groups, suggesting that this technique should not be considered standard practice for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blinded, randomized trial comparing surgeon-administered transversus abdominis plane block with placebo after midline laparotomy in gynecologic oncology surgery. Bernard, L., Lavecchia, M., Trepanier, G., et al.[2023]

In a study involving 28 adult female patients undergoing elective gynaecological surgery, the transversus abdominis plane block with 3 mg/kg of ropivacaine resulted in peak plasma concentrations that could be potentially neurotoxic, reaching a mean of 2.54 µg/ml 30 minutes post-injection.

Despite the potential for toxicity, the plasma concentrations observed were similar to those found in other injection sites, suggesting that while caution is needed, the technique may still be safe when monitored properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block. Griffiths, JD., Barron, FA., Grant, S., et al.[2022]

The transversus abdominis plane (TAP) block provided significantly longer-lasting analgesia and lower pain scores compared to direct infiltration of local anesthetic in a study of 52 patients undergoing lower abdominal surgeries.

Patients receiving the TAP block required less morphine for pain management and experienced fewer side effects, such as sedation and postoperative nausea and vomiting, indicating it is a safer and more effective analgesic technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of analgesic efficacy of transversus abdominis plane block with direct infiltration of local anesthetic into surgical incision in lower abdominal gynecological surgeries. Sivapurapu, V., Vasudevan, A., Gupta, S., et al.[2022]

The transversus abdominis plane block significantly reduced postoperative pain scores for 8 to 12 hours after gynecological surgeries, demonstrating its efficacy as an analgesic technique.

Patients receiving the transversus abdominis plane block required less opioid medication compared to those receiving local bupivacaine infiltration, indicating a potential benefit in minimizing opioid use post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of ultrasound guided transversus abdominis plane block versus local wound infiltration for post operative analgesia in patients undergoing gynaecological surgery under general anaesthesia. Ranjit, S., Shrestha, SK.[2019]

In a study involving 60 patients undergoing laparoscopic radical prostatectomy, both subcutaneous wound infiltration (WI) and transversus abdominis plane (TAP) block provided effective pain control, with no significant differences in pain scores or opioid requirements post-surgery.

The results suggest that both techniques are equally effective as part of a multimodal analgesic approach, with very low pain scores and minimal complications, indicating that neither method offers a clear advantage over the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound infiltration or transversus abdominis plane block after laparoscopic radical prostatectomy: a randomized clinical trial. Tejedor, A., Deiros, C., Bijelic, L., et al.[2023]

In a study of 40 patients undergoing laparoscopic hysterectomy, the addition of a transversus abdominis plane block to systemic analgesia did not significantly reduce opioid consumption or pain intensity compared to systemic analgesia alone.

The results suggest that while the transversus abdominis plane block is a common technique for pain management, it may not provide additional benefits in this specific surgical context, potentially increasing preparation time and costs without improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ultrasound-guided transversus abdominis plane block in laparoscopic hysterectomy. Clinical trial. Guardabassi, DS., Lupi, S., Agejas, R., et al.[2018]

Bilateral continuous lumbar transversus abdominis plane blocks provided effective postoperative pain relief for a high-risk patient after major abdominal surgery, allowing her to avoid systemic opioids for 81 hours.

This technique resulted in a prolonged sensory block level from T6 to L1, which lasted for 24 hours after stopping the infusion, suggesting it may be a safer alternative to epidural anesthesia and systemic pain medications in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous lumbar transversus abdominis plane block may spread to supraumbilical dermatomes. Forero, M., Neira, VM., Heikkila, AJ., et al.[2011]

The transversus abdominis plane block, performed with laparoscopic guidance, effectively reduces postoperative pain in patients undergoing laparoscopic colorectal surgery, enhancing analgesia after the procedure.

This improved method allows for precise needle placement and confirmation of injectate spread, suggesting it could be a valuable addition to postoperative care, although further randomized trials are needed to fully evaluate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic-guided transversus abdominis plane block for colorectal surgery. Favuzza, J., Delaney, CP.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11675870/

The Efficacy of Transversus Abdominis Plane (TAP) Blocks ... TAP blocks have been shown to lower postoperative pain scores, decrease postoperative opioid consumption, decrease the need for anti-emetics, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06731998

Optimal Perioperative Pain Control in Minimally Invasive ... Laparoscopic Transversus Abdominis Plane block (LapTAP) has emerged as a new approach for postoperative pain control following minimally invasive surgery, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1743919122006021

Transversus abdominis plane block for laparoscopic ... Evidence demonstrated that laparoscopic surgery provided similar oncologic outcomes and better post-operative recoveries with comparison to open surgery in the ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1080327/full

Laparoscopic versus ultrasound-guided transversus ... Our meta-analysis will summarize all the available evidence for the effectiveness and safety of TAPB approaches for minimally invasive colorectal surgery.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33823786/

Analgesic efficacy of postoperative bilateral, ultrasound ... A postoperative bilateral, ultrasound-guided, posterior TAP block resulted in better pain management and a faster recovery in patients undergoing laparoscopic ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465020303034

Efficacy and Safety of a Surgeon-Performed Laparoscopic ... In summary, our data demonstrated the safety and efficacy of a surgeon-performed, laparoscopically guided, 4-point TAP block in robot-assisted gynecologic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9010526/

Efficacy of Transversus Abdominis Plane Block in Patients ... This study aimed to evaluate the efficacy of transversus abdominis plane block (TAPB) in patients after laparoscopic radical cervical cancer ...

8. link.springer.com link.springer.com/article/10.1007/s00423-025-03752-2

Efficacy of bupivacaine liposome transversus abdominis ... This indicates that using liposomal bupivacaine for TAP block in abdominal surgery is safe and can provide sustained analgesia for over 48 h, ...

9. ls.amegroups.org ls.amegroups.org/article/view/7372/html

Gastrointestinal outcomes following transversus abdominus ... This systematic review aimed to explore the relationship between intra-operative TAP block and incidence of post-operative ileus. It was ...