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Oncologic SurgeryLapTAPNCT06731998

Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

A study testing Local Anesthesia and Laparoscopic Transversus Abdominis Plane block in people with Oncologic Surgery and Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Oncologic Surgery, Cancer, Cancer Surgery
What is being tested?
Local Anesthesia and Laparoscopic Transversus Abdominis Plane block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
5 Feb 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients age ≥ 18 - 89
  • Patients scheduled for elective (clinically indicated) hepatic, gastric, biliary, pancreatic, gynecologic, colorectal, other GI Minimally invasive oncologic surgery.
  • Patients who have provided informed consent to participate in the study.
  • Patients with an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
  • Patients undergoing procedures anticipated to last more than 1 hour but less than 8 hours.
  • Patients able to understand and self-report pain using the designated pain Visual Analog Scale

Who cannot join

  • Patients age less than 18 or ≥ 90
  • Pre-existing hepatic dysfunction, cirrhosis
  • Patients with an ASA classification of IV or higher.
  • Patients with chronic pain disorders or on long-term opioid or analgesic therapy.
  • Patients with known contraindications to the study drugs or procedures (e.g., allergy to LA or contraindications to LapTAP).
  • Patients with cognitive impairments or psychiatric conditions that could interfere with pain assessment or understanding of informed consent.
Show all 10Show fewer
  • Patients unable to understand the language in which consent and study-related information are provided (The study and the study-related information will be in the English Language)..
  • Patients who have undergone major surgery within the last 6 months.
  • Female patients who are pregnant.
  • Patients currently enrolled in another clinical trial that might interfere with the outcome measures of this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Casey Allen, MD contact

(412) 913-6466

casey.allen@ahn.org

AHN Clinical Trials Contact contact

412-913-6466

clinicaltrials@ahn.org

United States1 site, 1 recruiting
  • AHN West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Casey Allen, MD, (412) 913-6466, casey.allen@ahn.org

    AHN Clinical Trials Contact, clinicaltrials@ahn.org

    Recruiting

Other trials in United States

About this study

Official title: Evaluating Optimal Perioperative Pain Management: A Prospective Randomized Control Trial of Laparoscopic Transversus Abdominis Plane Block With Local Anesthetic, Laparoscopic Transversus Abdominis Plane Block Alone, and Local Anesthetic Alone in Minimally Invasive Oncologic Surgery

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.
Read the detailed description

Traditional pain management strategies have heavily relied on the use of Local Anesthesia (LA). Laparoscopic Transversus Abdominis Plane block (LapTAP) has emerged as a new approach for postoperative pain control following minimally invasive surgery, promising enhanced pain control in comparison with traditional approaches. Preliminary investigations into LapTAP have shown promise, yet there remains a significant gap in comparative effectiveness research, especially juxtaposed against the more traditional LA. We propose a comprehensive three-arm superiority trial evaluating LapTAP in conjunction with LA, LapTAP alone, and LA alone. We intend to scrutinize the efficacy of each modality in managing postoperative pain specific to minimally invasive oncologic surgery. Findings from this trial will be used to refine clinical protocols, improve patient outcomes, and potentially standardize care in postoperative pain management for minimally invasive oncologic procedures.

Being tested
Local Anesthesia, Laparoscopic Transversus Abdominis Plane block
Keywords
Laparoscopic Transversus Abdominis Plane Block, Local Anesthetic, Laparoscopic Surgical Procedure, pain management, cancer, cancer surgery, oncologic surgery, perioperative pain management, minimally invasive surgical procedures
Medical subject headings
Neoplasms, Liver Neoplasms, Biliary Tract Neoplasms, Gastrointestinal Neoplasms, Colorectal Neoplasms, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local AnesthesiaProcedure or surgery

    For local anesthetic administration at port sites, 30 mL of 0.1% ropivacaine is injected around the umbilical port site following the completion of the primary surgical procedure. Additionally, 5 mL of 0.1% ropivacaine is injected around each additional port site to ensure effective local anesthesia.

  • Laparoscopic Transversus Abdominis Plane blockProcedure or surgery

    Surgeon will place 18 gauge needle into the fascial plane between the internal oblique and transversus abdominis muscles. Once the needle is accurately positioned surgeon will inject 15 mL of 0.1% ropivacaine slowly. This procedure is performed bilaterally to ensure comprehensive analgesia. The total volume utilized for the LapTAP block is 30 mL of 0.1% ropivacaine.

Study groups in NCT06731998
Study groupRoleWhat they receive
Laparoscopic Transversus Abdominis Plane Block with Local AnestheticActive comparatorPatient would be receiving Laparoscopic Transversus Abdominis Plane block in addition to Local Anesthetic per standard of care.
Receives: Procedure: Local Anesthesia; Procedure: Laparoscopic Transversus Abdominis Plane block
Laparoscopic Transversus Abdominis Plane block onlyActive comparatorPatient would be receiving Laparoscopic Transversus Abdominis Plane block without Local Anesthetic per standard of care.
Receives: Procedure: Laparoscopic Transversus Abdominis Plane block
Local Anesthetic onlyActive comparatorPatient would be receiving Local Anesthetic per standard of care.
Receives: Procedure: Local Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Score

    Pain will be measured in the post anesthesia care unit (PACU) using Visual Analog Scale. Pain will be scored from zero to ten, with zero being no pain at all and ten being unbearable pain.

    Measured: Hourly, starting 1 hour post surgery for 24 hours, then at time of hospital discharge (on average 1 week)

Secondary outcomes (5)
  1. Opioid Consumption

    Opioid consumption (milligrams) within the first 24 hours post-surgery (standardize with Morphine equivalence).

    Measured: up to 24 hours post surgery

  2. Recovery Analgesic Time

    Time to first rescue analgesic request

    Measured: up to 24 hours post surgery

  3. Adverse Event(s) Frequency

    Frequency of any adverse events related to interventions

    Measured: immediately post surgery up through discharge (on average of 1 week)

  4. Adverse Event(s) Severity

    Severity of any adverse events related to interventions

    Measured: immediately post surgery up through discharge (on average of 1 week)

  5. Patient Satisfaction with Pain Management

    Will gauge patient perceptions of pain control and overall satisfaction with their treatment with a standardized Visual Analog Scale utilizing a zero to ten scale, with zero being completely dissatisfied and ten being completely satisfied.

    Measured: At discharge (on average of 1 week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start5 Feb 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731998
Sponsor's protocol ID
LapTAP
Acronym
LapTAP
Status last verified
Sep 2025
First submitted
12 Nov 2024
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not necessary for the scope of the study to share IPD.

Publications

  • 17. https://pain.ucsf.edu/fascial-plane-blocks/transversus-abdominis-plane-tap-block

  • Jones JH, Aldwinckle R. Interfascial Plane Blocks and Laparoscopic Abdominal Surgery: A Narrative Review. Local Reg Anesth. 2020 Oct 23;13:159-169. doi: 10.2147/LRA.S272694. eCollection 2020.

    PubMed 33122942
  • Guo Q, Li R, Wang L, Zhang D, Ma Y. Transversus abdominis plane block versus local anaesthetic wound infiltration for postoperative analgesia: A systematic review and meta-analysis. Int J Clin Exp Med. 2015 Oct 15;8(10):17343-52. eCollection 2015.

    PubMed 26770326
  • Hamid HK, Emile SH, Saber AA, Ruiz-Tovar J, Minas V, Cataldo TE. Laparoscopic-Guided Transversus Abdominis Plane Block for Postoperative Pain Management in Minimally Invasive Surgery: Systematic Review and Meta-Analysis. J Am Coll Surg. 2020 Sep;231(3):376-386.e15. doi: 10.1016/j.jamcollsurg.2020.05.020. Epub 2020 Jun 2.

    PubMed 32502615
  • Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.

    PubMed 21296242
  • Mannava S, Hafezi N, Turk F, Colgate C, Askegard-Giesmann J, Markel T, Horn N, Gray B. Transversus Abdominis Plane Block VS. Local Wound Infiltration for Elective Minimally Invasive Cholecystectomy in Children: A Prospective Randomized Trial. J Pediatr Surg. 2024 Jan;59(1):96-102. doi: 10.1016/j.jpedsurg.2023.09.020. Epub 2023 Sep 22.

    PubMed 37863700
  • Calle GA, Lopez CC, Sanchez E, De Los Rios JF, Vasquez EM, Serna E, Arango AM, Castaneda JD, Vasquez RA, Gonzalez A, Escobar A, Almanza LA. Transversus abdominis plane block after ambulatory total laparoscopic hysterectomy: randomized controlled trial. Acta Obstet Gynecol Scand. 2014 Apr;93(4):345-50. doi: 10.1111/aogs.12351.

    PubMed 24575769
  • Rajanbabu A, Puthenveettil N, Appukuttan A, Asok A. Efficacy of laparoscopic-guided transversus abdominis plane block for patients undergoing robotic-assisted gynaecologic surgery: A randomised control trial. Indian J Anaesth. 2019 Oct;63(10):841-846. doi: 10.4103/ija.IJA_471_19. Epub 2019 Oct 10.

    PubMed 31649397
  • El Hachem L, Small E, Chung P, Moshier EL, Friedman K, Fenske SS, Gretz HF 3rd. Randomized controlled double-blind trial of transversus abdominis plane block versus trocar site infiltration in gynecologic laparoscopy. Am J Obstet Gynecol. 2015 Feb;212(2):182.e1-9. doi: 10.1016/j.ajog.2014.07.049. Epub 2014 Aug 1.

    PubMed 25088860
  • Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

    PubMed 29026331
  • Ye SP, Zhu WQ, Huang ZX, Liu DN, Wen XQ, Li TY. Role of minimally invasive techniques in gastrointestinal surgery: Current status and future perspectives. World J Gastrointest Surg. 2021 Sep 27;13(9):941-952. doi: 10.4240/wjgs.v13.i9.941.

    PubMed 34621471
  • Small C, Laycock H. Acute postoperative pain management. Br J Surg. 2020 Jan;107(2):e70-e80. doi: 10.1002/bjs.11477.

    PubMed 31903595

Questions about this trial

What is this clinical trial studying?

A study testing Local Anesthesia and Laparoscopic Transversus Abdominis Plane block in people with Oncologic Surgery and Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Casey Allen, MD ((412) 913-6466, casey.allen@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score (time frame: Hourly, starting 1 hour post surgery for 24 hours, then at time of hospital discharge (on average 1 week)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06731998, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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