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Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

ConditionsOncologic SurgeryCancerCancer SurgeryHepatic CancerGastric (Cardia, Body) CancerBiliary Tract CancerPancreatic Cancer ResectableGynecologic CancersGastrointestinal CancersColorectal CancerMinimally Invasive Surgical Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Local Anesthesia

    Procedure/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 block

    Procedure/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.

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Laparoscopic Transversus Abdominis Plane Block with Local AnestheticActive comparator 2 interventions
Group B: Laparoscopic Transversus Abdominis Plane block onlyActive comparator 1 intervention
Group C: Local Anesthetic onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

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

Secondary outcomes

1

Opioid Consumption

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

Time frame
up to 24 hours post surgery
2

Recovery Analgesic Time

Time to first rescue analgesic request

Time frame
up to 24 hours post surgery
3

Adverse Event(s) Frequency

Frequency of any adverse events related to interventions

Time frame
immediately post surgery up through discharge (on average of 1 week)
4

Adverse Event(s) Severity

Severity of any adverse events related to interventions

Time frame
immediately post surgery up through discharge (on average of 1 week)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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