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

Trial Summary

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.

What data supports the effectiveness of the treatment Laparoscopic Transversus Abdominis Plane Block for pain management in cancer surgery?

Research shows that the transversus abdominis plane block, which involves injecting anesthetic between certain abdominal muscles, has been effective in reducing pain and the need for painkillers after various abdominal surgeries, including hysterectomy and prostatectomy. ^{1 2 3 4 5}

Is the transversus abdominis plane block generally safe for humans?

The transversus abdominis plane block is considered a safe and simple technique for pain relief in surgeries, but there is a possibility of toxic levels of local anesthetic in the blood if large doses are used. ^{3 5 6 7 8}

How is the Laparoscopic Transversus Abdominis Plane Block treatment different from other pain management options for cancer surgery?

The Laparoscopic Transversus Abdominis Plane Block is unique because it involves injecting a local anesthetic between specific abdominal muscles to target sensory nerves, providing pain relief after surgery. This method is guided by a laparoscope (a small camera), allowing precise placement of the anesthetic, which can enhance pain control compared to other techniques. ^{1 3 4 5 9}

What is the purpose of this trial?

This is a research study to evaluate the effectiveness of 3 different types of routine pain management regimens used during clinically indicated, minimally invasive oncologic (cancer) surgery. This project is considered "Research" and participation is voluntary. Upon enrollment in this study, the research team will collect data from the patient's medical records. The patient will undergo all of the normal testing and procedures required pre-operatively (standard of care). The study team will then randomly assign the patient (like a flip of a coin) to one of three different study arms for pain management during surgery: 1. Laparoscopic Transversus Abdominis Plane Block (LapTAP) with Local Anesthetic (LA) 2. Laparoscopic Transversus Abdominis Plane Block (LapTAP) only 3. Local Anesthetic (LA) only The patient will receive standard pre- and post-operative care according to clinical guidelines (routine care). The study team will collect information from the patient's medical record for the first 24 hours after their surgery and upon discharge. This information will include pain scores, amount of medication required, any side effects the patient may have experienced, and satisfaction with pain control. Participation in the study will end upon discharge from the hospital.

Research Team

Casey Allen, MD

Principal Investigator

Allegheny Health Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Wound infiltration or transversus abdominis plane block after laparoscopic radical prostatectomy: a randomized clinical trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Continuous lumbar transversus abdominis plane block may spread to supraumbilical dermatomes. [2011]

3. Brazil 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]. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic-guided transversus abdominis plane block for colorectal surgery. [2013]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block. [2022]

7. India 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. [2022]

8. Nepal 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. [2019]

9. Spain pubmed.ncbi.nlm.nih.gov

Efficacy of ultrasound-guided transversus abdominis plane block in laparoscopic hysterectomy. Clinical trial. [2018]