ClinicalTrials.Veeva

Menu

Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Postoperative Pain

Treatments

Drug: Ropivacaine 0.75% Injectable Solution
Device: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
Procedure: Ultrasound guided subcostal transversus abdominis plane block (TAPB)

Study type

Interventional

Funder types

Other

Identifiers

NCT04138901
HS-2019-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

112 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

112 participants in 2 patient groups

Group T
Experimental group
Description:
Patients receiving bilateral subcostal TAP block.
Treatment:
Procedure: Ultrasound guided subcostal transversus abdominis plane block (TAPB)
Drug: Ropivacaine 0.75% Injectable Solution
Device: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
Group C
No Intervention group
Description:
Patients not receiving bilateral subcostal TAP block.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems