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NCT Number: NCT04138901

Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.

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Key information

Conditions

Postoperative Pain Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, KS013, South Korea

About this study

Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia
  • American Society of Anesthesiologists (ASA) physical classification I-III
  • Consent to IV-patient controlled analgesia use
  • Willingness and ability to sign an informed consent document

Exclusion criteria

  • Do not understand our study
  • Allergies to anesthetic or analgesic medications
  • Wound infiltration analgesia for postoperative pain control
  • Infection or anatomic abnormality at the needle insertion site
  • Pregnancy/Breast feeder
  • Medical or psychological disease that can affect the treatment response

Treatment and study plan

Ultrasound guided subcostal transversus abdominis plane block (TAPB)

Procedure

At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.

Other names: TAP block

Ropivacaine 0.75% Injectable Solution

Drug

0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Device

0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Primary outcomes

  1. Total fentanyl consumption during 24 hours

    Time frame: postoperative 24 hours

    postoperative cumulative fentanyl consumption (mcg)

Secondary outcomes

  1. Total fentanyl consumption

    Time frame: postoperative 6, 12, 48 hours

    postoperative cumulative fentanyl consumption (mcg)

  2. Postoperative pain score

    Time frame: postoperative 6, 12, 24, 48 hours

    11-pointed NRS pain score at resting/coughing NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"

  3. occurrence of opioid-related side effects

    Time frame: postoperative 6, 12, 24, 48 hours

    Incidence of postoperative nausea and vomiting, dizziness, sedation, respiratory depression (%)

  4. Rescue nonopioid(ketorolac, nefopam) analgesic requirement

    Time frame: postoperative 6, 12, 24, 48 hours

    Overall postoperative rescue of nonopoioid(ketorolac, nefopam) analgesic requirement

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2019
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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