Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study
Overview
- Phase
- Not Applicable
- Intervention
- Ultrasound guided subcostal transversus abdominis plane block (TAPB)
- Conditions
- Postoperative Pain
- Sponsor
- Seoul National University Hospital
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Total fentanyl consumption during 24 hours
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Hojin Lee, MD
Clinical assistant professor
Seoul National University Hospital
Eligibility Criteria
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
Arms & Interventions
Group T
Patients receiving bilateral subcostal TAP block.
Intervention: Ultrasound guided subcostal transversus abdominis plane block (TAPB)
Group T
Patients receiving bilateral subcostal TAP block.
Intervention: Ropivacaine 0.75% Injectable Solution
Group T
Patients receiving bilateral subcostal TAP block.
Intervention: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
Outcomes
Primary Outcomes
Total fentanyl consumption during 24 hours
Time Frame: postoperative 24 hours
postoperative cumulative fentanyl consumption (mcg)
Secondary Outcomes
- Rescue nonopioid(ketorolac, nefopam) analgesic requirement(postoperative 6, 12, 24, 48 hours)
- Total fentanyl consumption(postoperative 6, 12, 48 hours)
- Postoperative pain score(postoperative 6, 12, 24, 48 hours)
- occurrence of opioid-related side effects(postoperative 6, 12, 24, 48 hours)